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2008 Safety Alerts for Human Medical Products
(Drugs, Biologics, Medical Devices, Special Nutritionals, and Cosmetics)

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Biologics (CBER):

 

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Special Nutritional Products and Cosmetics:

Aspire36, Aspire Lite Dietary Supplements (posted 03/04/2008)
"Blue Steel" and "Hero" Dietary Supplement Products (posted 03/25/2008)
Calcilo XD Low-Calcium & Vitamin D-Free Infant Formula With Iron Powder (posted 06/02/2008)
Herbal Science International, Inc. Dietary Herbal Supplements (posted 04/14/2008)
Infant Formula Manufactured in China (posted 09/12/2008; UPDATE 09/22/2008)
Rize 2 The Occasion Capsules and Rose 4 Her Capsules (posted 07/02/2008; UPDATE 07/30/2008)
Total Body Formula, Total Body Mega Formula (posted 03/28/2008; UPDATED 05/01/2008)
Viapro 375mg Capsules (posted 07/31/2008)
Viril-ity Power (VIP) Tablets (posted 05/30/2008)
Weight Loss Pills (posted 12/22/2008) New
Xiadafil VIP Tablets (posted 05/27/2008)

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Drugs and Therapeutic Biological Products (CDER):

2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product (posted 06/30/2008)
20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP (posted 12/09/2008)
Abacavir (marketed as Ziagen) and Abacavir-containing Medications (posted 07/24/2008)
Amiodarone (used with simvastatin) (posted 08/08/2008)
Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% (posted 09/18/2008)
Antiepileptic Drugs (posted 01/31/2008; UPDATE 12/16/2008)
Antipsychotics, Conventional and Atypical (posted 05/29/2008)
Avandia (rosiglitazone maleate) (posted 02/26/2008)
Avastin (bevacizumab) (posted 07/14/2008)
B. Braun Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride Injection Solution (posted 03/21/2008)
Benzoyl Peroxide Acne Cream 10% (posted 11/12/2008)
Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D), Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel, Actonel W/Calcium), Tiludronate (Skelid), Zoledronic acid (Reclast, Zometa) (posted 11/12/2008)
Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa) (posted 01/07/2008)
Botox, Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B) (posted 02/06/2008)
Byetta (exenatide) (posted 02/27/2008; UPDATE 08/18/2008)
Cardinal Alcohol-Free Mouthwash (posted 05/06/2008; UPDATE 05/19/2008)
CellCept (mycophenolate mofetil) (posted 04/10/2008; UPDATE 06/26/2008)
Colchicine, Injectable (including drugs containing colchicine) (posted 02/06/2008)
Compounded Menopause Hormone Therapy Drugs (posted 01/10/2008)
Cubicin (daptomycin for injection) (posted 04/09/2008)
Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) (UPDATED 08/07/2008)
Dextroamphetamine Sulfate Tablets 10 mg (posted 11/10/2008)
Dextroamphetamine Sulfate 5mg Tablets (posted 10/16/2008)
Digitek (digoxin tablets, USP) (posted 04/28/2008)
Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches (posted 02/15/2008)
Edetate Disodium (marketed as Endrate and generic products) (posted 01/16/2008)
Enbrel (etanercept) (posted 05/01/2008)
Epoetin alfa - Early Communication about an Ongoing Safety Review (posted 09/26/2008)
Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa) (posted 07/31/2008; UPDATED 08/08/2008, 12/02/2008)
Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa) (posted 03/12/2008)
Exubera (insulin human rDNA origin) Inhalation Powder (posted 04/09/2008)
Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor), and Ezetimibe (marketed as Zetia): Early Communication About an Ongoing Safety Review (posted 08/21/2008)
Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor): Early Communication about an Ongoing Data Review (posted 01/25/2008; UPDATED 01/08/2009) New
Fentanyl transdermal system CII Patches (posted 02/19/2008; UPDATED 03/03/2008)
Fluoroquinolone Antimicrobial Drugs (posted 07/08/2008)
Foradil (formoterol fumarate inhalation powder) Capsules (posted 02/29/2008)
Fosphenytoin Sodium (marketed as Cerebyx and generics) (posted 11/24/2008)
Heparin Sodium USP Pre-Filled Syringes (Posted 04/02/2008)
Heparin Sodium Injection (Posted 02/11/2008, UPDATED 02/28/2008, 03/11/2008, 04/29/2008; 05/09/2008; 05/15/2008)
Heparin Sodium Injection 1000 units/mL 1OmL and 30 mL Vials (posted 01/19/2008; updated 01/29/2008)
Herceptin 440 mg and Herceptin BWFI diluent (posted 07/08/2008)
Hydromorphone HCl 2 mg Tablets (posted 12/24/2008) New
Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) (posted 11/12/2008)
Innohep (tinzaparin sodium injection) (posted 11/24/2008; updated 12/31/2008) New
Isosorbide Mononitrate Extended Release Tablets 30 mg and 60 mg (posted 11/10/2008)
Leukine (sargramostim) (posted 01/19/2008)
Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension) (posted 03/11/2008; UPDATE 04/24/2008)
Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) (posted 07/17/2008)
Mitoxantrone Hydrochloride (marketed as Novantrone and generics) (posted 07/29/2008)
MOM Enterprises Mommy's Bliss Nipple Cream (posted 05/29/2008)
Morphine Sulfate Immediate Release Tablets 15 mg and 30 mg (posted 11/10/2008)
Morphine Sulfate Extended Release Tablets 15 mg (posted 11/10/2008)
Morphine Sulfate 60 mg Extended Release Tablets (posted 06/10/2008)
Mycophenolate Mofetil [MMF] (marketed as CellCept) (posted 05/16/2008)
Mycophenolic Acid [MPA] (marketed as Myfortic) (posted 05/16/2008)
Myfortic (mycophenolate acid) (posted 04/10/2008; UPDATED 07/01/2008)
Neupro (rotigotine transdermal system) (posted 04/09/2008)
NuCel Labs Eye Drops and Eye/Ear Wash Products (posted 01/31/2008)
Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription) (posted 12/11/2008)
Ortho Evra Contraceptive Transdermal Patch (posted 01/19/2008)
Over The Counter Cough and Cold Medications (posted 10/09/2008)
Phenytoin (marketed as Dilantin, Phenytek and generics)
Phosphocol P 32 (Chromic Phosphate P 32 Suspension) (posted 09/18/2008)
Prezista (darunavir) (posted 03/12/2008; UPDATED 03/21/2008)
Propafenone HCl Tablets 150 mg, 225 mg, and 300 mg (posted 11/10/2008)
Raptiva (efalizumab) (posted 10/17/2008)
Regranex (becaplermin) Gel (posted 03/27/2008; UPDATED 06/06/2008)
Relenza (zanamivir) (posted 04/02/2008)
Rituxan (rituximab) (posted 09/11/2008)
Simvastatin Used With Amiodarone (posted 08/08/2008)
Singulair (montelukast) (posted 03/27/2008; UPDATE 01/13/2009) New
Sodium Polystyrene Sulfonate Suspension (posted 07/16/2008)
Solodyn (minocycline HCL) Extended Release Tablets 90 mg (posted 05/19/2008)
Spiriva (tiotropium bromide inhalation powder) Capsules (posted 02/29/2008)
Starcaps Dietary Supplement Capsules (posted 11/26/2008; UPDATED 12/09/2008)
Tamiflu (oseltamivir phosphate) (posted 03/04/2008)
Tarceva (erlotinib) (posted 09/23/2008)
Tiotropium (marketed as Spiriva HandiHaler) (posted 03/18/2008; UPDATED 10/07/2008)
Trasylol (aprotinin injection) (UPDATE 05/14/2008)
Tumor necrosis factor-α blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab) (posted 09/04/2008)
Tumor Necrosis Factor Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) (posted 06/03/2008)
Tysabri (natalizumab) (posted 08/25/2008)
Tysabri (natalizumab) (posted 02/27/2008)
Unapproved Over The Counter Drugs Marketed for Prevention and Treatment of STDs (posted 03/06/2008)
Varenicline (marketed as Chantix) (posted 02/01/2008)
Videx (didanosine) (posted 03/27/2008)
Vivitrol (naltrexone) (posted 08/12/2008)
Weight Loss Pills (posted 12/22/2008)
Zhen De Shou Fat Loss Capsules (posted 11/26/2008)
Ziagen (abacavir) (posted 03/27/2008)

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Medical Devices:

Animas Corporation Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump (posted 11/20/2008)
Blood Glucose Meters and Test Strips (posted 03/11/2008)
Boston Scientific NexStent Monorail (posted 08/14/2008)
Chattem Icy Hot Heat Therapy Products (posted 02/11/2008; UPDATED 03/11/2008)
Cordis Corporation Dura Star RX and Fire Star RX PTCA Balloon Catheters (posted 01/25/2008; updated 01/28/2008)
Denture Cleanser Allergic Reactions and Misuse (posted 02/26/2008)
Disposable Battery Operated Lavage System (BOLS) (posted 09/08/2008)
Electronic Medical Devices (posted 07/16/2008)
Gravity Compensating Accessory, High Pressure Range, Sterile, Single Use, by Integra NeuroSciences (posted 12/11/2008) New
Greenline/D MacIntosh No. 3 Laryngoscope Blades (posted 12/19/2008) New
Healon D Ophthalmic Viscosurgical Device (posted 12/11/2008) New
Heparin and Normal Saline Pre-Filled Flushes (posted 01/18/2008; updated 01/28/2008, updated 01/30/2008)
Heparin Sodium Injection (Baxter) (Posted 02/11/2008, UPDATED 02/28/2008, 03/11/2008, 04/29/2008, 05/09/2008)
Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software) (posted 08/01/2008)
LifePak CR Plus Automated External Defibrillators (posted 09/11/2008)
Medtronic AneuRx Stent Graft System (posted 03/18/2008)
Medtronic INDURA 1P Intrathecal Catheter, Sutureless Pump Connector Revision Kit, Intrathecal Catheter Pump Segment Revision Kit (posted 10/02/2008)
Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps (posted 03/21/2008)
Medtronic SynchroMed EL Implantable Infusion Pump (posted 02/04/2008)
Nebion HLX-8 Magnetic Resonance Device (posted 10/03/2008)
Pacific Consolidated brand Mobile Oxygen Storage Tank (posted 08/28/2008)
Radio Frequency Ablation Devices (UPDATE to 12/12/2007 MedWatch notice, posted 09/26/2008)
Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion (posted 07/02/2008)
ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien) (posted 11/06/2008)
Stryker Custom Cranial Implant Kits (posted 12/24/2008) New
Terumo Cardiovascular Systems Tenderflow Pediatric Arterial Cannulae (posted 12/08/2008)
Thoratec HeartMate II Left Ventricular Assist System (posted 10/28/2008)
Transvaginal Placement of Surgical Mesh (posted 10/21/2008)
Unretrieved Device Fragments (posted 01/15/2008)
Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator (posted 10/31/2008)

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2008 Medical Product Safety Alerts, listed in reverse chronological order (most recent first). For an alphabetical listing, return to the categories on this page. You may also search the entire MedWatch site by keyword at the top of this Safety Information page.

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Stryker Custom Cranial Implant Kits
Audience: Maxillofacial surgeons, hospital risk managers
[Posted 12/24/2008] Stryker Leibinger USA and FDA notified healthcare professionals of a Class 1 recall of all sizes of the cranial implant kit distributed from November 5, 2007 through October 23, 2008. The company is recalling these products because sterility cannot be assured. Custom cranial implants are designed individually for each patient to correct trauma and/or defects in the lower jaw, upper jaw and face or the cranium and the face. Implanting surgeons were notified individually of the problem in a October 24, 2008 recall letter. The letter advised them of the risk for serious infections, and instructed them to follow-up with patients for infections for at least six months after surgery. The recall letter also included details for identifying and returning any remaining implant kits.

[December 23, 2008 - Press Release - Stryker]
[December 23, 2008 - Recall Notice - FDA]

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Hydromorphone HCl 2 mg Tablets
Audience: Pharmacists, consumers, primary care healthcare professionals
[Posted 12/24/2008] ETHEX and FDA notified heathcare professionals of a nationwide recall of a single lot of Hydromorphone HCl 2 mg Tablets due to potential for oversized tablets. Hydromorphone is a drug used for pain management. If someone were to take a higher than expected dose of Hydromorphone, the risk of adverse effects known to be associated with the drug may be increased, including respiratory depression (difficulty or lack of breathing), low blood pressure, and sedation. The recalled tablets are a blue, round tablet with a script "E" on one side and a "2" on the other side.

The parent company of ETHEX Corporation, KV Pharmaceutical has advised FDA that it is voluntarily suspending shipments of all FDA-approved drug products in tablet form. This action is being taken as a precautionary measure, to allow KV to address manufacturing issues that have come to management’s attention. See the link below for a list of tablets affected by suspended shipments.

[December 23, 2008 - Press Release - Ethex]
[December 23, 2008 - Press Release - KV]
[December 23, 2008 - Tablets Affected by Suspended Shipments - KV]

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Weight Loss Pills
Audience: Consumers, primary care healthcare professionals
[Posted 12/22/2008] FDA alerted consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk. The undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant ( a drug not approved for marketing in the United States), phenytoin ( an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). The weight loss products, some of which are marked as "dietary supplements," are promoted and sold on various web sites and in some retail stores.

FDA advises consumers who use the products to stop taking them and consult their healthcare professional immediately as the health risks posed by these products can be serious (for example, high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke). FDA also encourages consumers to seek guidance from healthcare professional before purchasing weight loss products. See the FDA News Release for a listing of the names of the 25 referenced products.

[December 22, 2008 - News Release - FDA]
[December 22, 2008 - Consumer Questions and Answers - FDA]

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Greenline/D MacIntosh No. 3 Laryngoscope Blades
Audience: ENT, anesthesia, and critical care healthcare professionals, hospital risk managers
[Posted 12/19/2008] Sun Med and FDA notified healthcare professionals of the Class 1 recall of Greenline/D MacIntosh No. 3 Laryngoscope Blades. This product is a part of a medical device [laryngoscope] used to view the vocal cords and other structures when opening a patient’s airway. A piece of the acrylic light tube that runs along the laryngoscope blade may break off during the procedure. This device was distributed from January 16, 2007 through April 13, 2007. The company sent a notice to their distributors requesting that the product be returned.

[December 18, 2008 - Recall Notice - FDA]

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Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription)
Audience: All healthcare professionals, consumers
[Posted 12/11/2008] FDA has become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to colonoscopy or other procedures. These products include the prescription products, Visicol and OsmoPrep, and OSPs available over-the-counter without a prescription as laxatives (e.g., Fleet Phospho-soda). In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury.

FDA is requiring the manufacturer of Visicol and OsmoPrep, the two OSPs available by prescription only, to add a Boxed Warning to the labeling for these products. FDA is also requiring that the manufacturer develop and implement a risk evaluation and mitigation strategy (REMS), which will include a Medication Guide, to ensure that the benefits of these products outweigh the risk of acute phosphate nephropathy, and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with use of these products. FDA recommends, in light of the risk of acute phosphate nephropathy, over-the-counter laxative OSP products should not be used for bowel cleansing. Consumers should only use OSPs for bowel cleansing pursuant to a prescription from a healthcare professional.

[December 11, 2008 - Drug Information Page - FDA]

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Gravity Compensating Accessory, High Pressure Range, Sterile, Single Use, by Integra NeuroSciences
Audience: Hospital surgical and neurological healthcare professionals
[Posted 12/11/2008] Integra NeuroSciences and FDA notified healthcare professionals of a recall of the Gravity Compensating Accessory (GCA), manufactured in January, 2008 through May, 2008 and distributed from February 22, 2008, through June 1, 2008. The GCA is part of a system that redirects (shunts) excess fluid from the brain to the abdomen. The GCA prevents too much fluid from being redirected from the brain while sitting or standing. The recalled devices may leak cerebrospinal fluid which may cause inflammation of brain, spinal cord, or abdominal membranes, pressure on the wound created by implantation of the device, or failure of the shunt system. Patients should contact their healthcare professional with any questions or concerns.

[December 11, 2008 - Recall Notice - FDA]

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Healon D Ophthalmic Viscosurgical Device
Audience: Ophthalmologic healthcare professionals
[Posted 12/11/2008] Advanced Medical Optics (AMO), Inc. and FDA notified healthcare professionals of a Class I recall of Healon D Ophthalmic Viscosurgical Device, Lot Number UD30654, 30 mg/mL fill size syringes. Some of the tested OVD syringes had endotoxin levels above the required limit. These higher levels may cause intraocular inflammation and/or Toxic Anterior Segment Syndrome in patients following surgery. Healthcare professionals should stop using and remove from their inventory all units of the affected lot and contact AMO at 1-877-266-4543.

[January 02, 2009 - News Release - FDA]
[December 10, 2008 - Recall Notice - FDA]

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20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP
Audience: Hospital pharmacists, hospital risk managers, other healthcare professionals
[Posted 12/09/2008] Hospira, Inc. notified healthcare professionals of a recall of one lot (lot number 65-620-FW, expiration date May 1, 2010, NDC 0409-7902-09) of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP in 1000 mL flexible plastic containers. A small number of the containers may be incorrectly labeled with a bar code for 5% Dextrose Injection, USP (NDC 0409-7922-09). The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication. Potential adverse events related to an error of this type include electrolyte imbalance, cardiac dysfunction, gastrointestinal disturbances, paresthesia and mental confusion. The affected lot was shipped to U.S. customers between July 2008 and September 2008. Healthcare facilities with an existing inventory should quarantine the product immediately and call Hospira Customer Care at 1-877-946-7747 for instructions on how to return it.

[December 08, 2008 - Press Release - Hospira, Inc.]

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Terumo Cardiovascular Systems Tenderflow Pediatric Arterial Cannulae
Audience: Cardiological healthcare professionals, hospital risk managers
[Posted 12/08/2008] Terumo Cardiovascular Systems notified healthcare professionals of a worldwide recall of its Tenderflow Pediatric Arterial Cannulae involving 21 lot codes (see Terumo press release for complete list). Terumo received five reports of difficulty retracting the introducer from the cannula. When the introducer cannot be retracted from the cannula, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death. Healthcare professionals are advised to not use the product unless medically necessary. In those cases, the cannula should be used without the introducer.

[December 01, 2008 - Press Release - Terumo Cardiovascular Systems]

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Innohep (tinzaparin sodium injection)
Audience: Hematological and Nephrological healthcare professionals, hospital risk managers
[UPDATE 12/31/2008] Celgene has issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency. It recommended consideration of alternatives to Innohep when treating these patients for deep vein thrombosis with or without pulmonary embolism.

[Posted 12/02/2008] FDA has received information about the clinical study: Innohep in Renal Insufficiency Study (IRIS) that was stopped in February, 2008 by the study’s Data Safety Monitoring Committee because of an interim finding of an increase in all-cause mortality in patients who received Innohep. Information on the patients enrolled in the study, on the heparin used to manufacture Innohep, and on the heparin used in the study is still being collected and analyzed.

In July 2008, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age or older. FDA is concerned that the preliminary data from the IRIS study suggest that the increased risk of mortality is not limited only to patients 90 years of age or older. Therefore, FDA has requested that the company revise the labeling for Innohep to better describe the overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and DVT, PE, or both. This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA anticipates submission of the final IRIS study report in January, 2009 and plans to complete its review soon thereafter. FDA will communicate its conclusions and any resulting recommendations to the public at that time. FDA will consider additional regulatory actions as appropriate after thorough review of all applicable data from the manufacturer of Innohep.

[December 02, 2008 - Communication about an Ongoing Safety Review - FDA]

[December 31, 2008 - Dear Healthcare Professional letter - Celgene]

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Starcaps Dietary Supplement Capsules
Audience: Consumers, healthcare professionals
[UPDATED 12/09/2008] Balanced Health Products, Inc. expanded its voluntarily recall to include additional Lot Numbers 12/2009 – 82866 and 12/2010 - 83801, sold in 30 capsule plastic bottles.

[Posted 11/26/2008] Balanced Health Products, Inc. announced a recall of STARCAPS due to the presence of an undeclared drug ingredient, Bumetanide. Bumetanide is a diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease including nephrotic syndrome. Potential risks associated with the use of Bumetanide include serious and significant fluid and electrolyte loss and an elevation in uric acid concentrations. Consumers should not take Bumetanide if they are allergic to sulfonamides. Significant drug interactions with Bumetanide, such as with digoxin and lithium, may lead to an increase risk of toxicity. Patients may also be at an increased risk of hypotension (low blood pressure), fainting (syncope) and resultant injury if they have normal blood pressure or are already taking an antihypertensive medication and take STARCAPS with undeclared Bumetanide. Consumers who have this product should immediately discontinue taking it and return the product to the manufacturer. See the company's press release for specific lot number information.

[December 08, 2008 - Press Release - Balanced Health Products, Inc.]
[November 24, 2008 - Press Release - Balanced Health Products, Inc.]

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Zhen De Shou Fat Loss Capsules
Audience: Consumers, healthcare professionals
[Posted 11/26/2008] Fashion Sanctuary announced a recall of Zhen De Shou Fat Loss Capsules because FDA analysis found the product to contain undeclared sibutramine, an FDA approved drug used as an appetite suppressant for weight loss. This poses a potential threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. The product was primarily distributed in the U.S and sold via the Internet and the recall affects all lot codes and use by dates. Consumers who may have purchased product from this company should immediately discontinue using the product.

[November 23, 2008 - Press Release - Fashion Sanctuary]

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Phenytoin (marketed as Dilantin, Phenytek and generics) and Fosphenytoin Sodium (marketed as Cerebyx and generics)
Audience: Neurological healthcare professionals
[Posted 11/24/2008] FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais. Until the FDA evaluation is completed, healthcare providers who are considering the use of phenytoin or fosphenytoin should be aware of the risks and benefits described in the current prescribing information for this drug. Healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502. A summary of the data currently being analyzed by FDA, and information for patients and healthcare professionals to consider, can be found in the links provided below.

[November 24, 2008 - Drug Information Page - FDA]
[November 24, 2008 - Information for Healthcare Professionals - FDA]

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Animas Corporation Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump
Audience: Consumers, endocrinological healthcare professionals
[Posted 11/20/2008] Animas Corporation and FDA informed consumers and healthcare professionals of a nationwide recall of battery caps used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump. The battery caps used with the above infusion pumps were manufactured from June 1, 2008 through July 31, 2008, and were distributed from June 16, 2008 through August 1, 2008.

There may be an intermittent loss of contact between the battery cap and the battery compartment in the pump which may result in the device resetting. This can cause the device to stop administering insulin, which could result in an excess level of glucose in the blood (hyperglycemia). Additionally, this failure may lead to user confusion in the amount of insulin administered, contributing to errors in future doses, which may result in lower than normal level of glucose in the blood (hypoglycemia). Healthcare professionals are advised to ensure that their patients replace the battery cap on their insulin pump.

[November 20, 2008 - Recall Notice - FDA]

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Benzoyl Peroxide Acne Cream 10% marked as:
DG Maximum Strength Acne Medicated Gel
Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication
Equate: Medicated Acne Gel

Audience: Consumers, dermatologists, pharmacists, other healthcare professionals
[Posted 11/17/2008] CSI USA Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of all lots of 1 ounce tubes of 10% Benzoyl Peroxide Acne Cream. The products were recalled because samples of the products were found to contain bacteria, Burkholderia Cepacia, formerly known as Pseudomonas Cepacia. There may be an increased health risk of infections for individuals with cuts, scrapes, rashes or other compromised skin conditions; or those with weakened or suppressed immune systems. Consumers should discontinue using the product and should return it to the place of purchase. See the company's press release for photos of product packaging.

[November 13, 2008 - Press Release - CSI USA Inc.]

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Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D)
Etidronate (Didronel)
Ibandronate (Boniva)
Pamidronate (Aredia)
Risedronate (Actonel, Actonel W/Calcium)
Tiludronate (Skelid)
Zoledronic acid (Reclast, Zometa)

Audience: Geriatricians, gynecologists, orthopedic surgeons, other healthcare professionals
[Posted 11/12/2008] FDA issued an update to the Agency's review of safety data regarding the potential increased risk of atrial fibrillation in patients treated with a bisphosphonate drug. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, and to treat bone metastases and lower elevated levels of blood calcium in patients with cancer. FDA reviewed data on 19,687 bisphosphonate-treated patients and 18,358 placebo-treated patients who were followed for 6 months to 3 years. The occurrence of atrial fibrillation was rare within each study, with most studies containing 2 or fewer events. Across all studies, no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation was observed. Additionally, increasing dose or duration of bisphosphonate therapy was not associated with an increase rate of atrial fibrillation. Healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication.

[November 12, 2008 - Update to the October 1, 2007 Early Communication about the Ongoing Safety Review of Bisphosphonates - FDA]

Previous MedWatch alert:
[October 1, 2007]

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Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas)

Audience: Consumers, pediatricians, other healthcare professionals
[Posted 11/12/2008] Johnson & Johnson, Merck Consumer Pharmaceuticals Company and FDA notified consumers and healthcare professionals of a voluntary recall of Infants' Mylicon Gas Relief Dye Free Drops ( Lot No. SMF007 and SMF008) sold in 1 oz plastic bottles that were distributed after October 5, 2008, nationwide. The product was recalled because some bottles could include metal fragments that were generated during the manufacturing process. Parents who have given the product to their infant and are concerned should contact their healthcare professional.

[November 07, 2008 - Press Release - Johnson & Johnson • Merck Consumer Pharmaceuticals Company]

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Propafenone HCl Tablets 150 mg, 225 mg, and 300 mg
Isosorbide Mononitrate Extended Release Tablets 30 mg and 60 mg
Morphine Sulfate Extended Release Tablets 15 mg
Morphine Sulfate Immediate Release Tablets 15 mg and 30 mg
Dextroamphetamine Sulfate Tablets 10 mg

Audience: Pharmacists, other healthcare professionals, patients
[Posted 11/10/2008] Ethex Corp and FDA notified healthcare professionals of a voluntary recall of five generic products (Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets, and Dextroamphetamine Sulfate Tablets). The products were recalled because they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient that could result in patients receiving as much as twice the expected dosage of these drugs, which could cause serious or life-threatening consequences.

Overdoses can include arrhythmias and low blood pressure with Propafenone HCl; fainting and low blood pressure with Isosorbide Mononitrate; respiratory depression and low blood pressure with Morphine Sulfate; and rapid heart rate and high blood pressure with Dextroamphetamine Sulfate. Patients who experience any adverse reactions to these drugs should contact their healthcare professional immediately. See the manufacturer's recall notice for specific lot numbers of the products affected by this recall.

[November 07, 2008 - Press Release - Ethex Corp]

Previous MedWatch Alert:

[October 16, 2008]

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ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)
Audience: Patients with insulin-dependent diabetes; pharmacists
[Posted 11/06/2008] Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles. The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death. These syringes are sold only by Wal-Mart or Sam's Club pharmacies under the ReliOn name. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes. FDA urges patients and health care professionals to check syringe packaging carefully for products with this lot number, not to use the product, and return the product to the pharmacy for replacement. The lot number can be found on the back panel of the 100 count syringe carton, or on the white paper backing of each individual syringe “peel-pack”.

[November 06, 2008 - Recall Notice - FDA]
[November 05, 2008 - News Release - FDA]

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Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator
Audience: Healthcare professionals
[Posted 10/31/2008] FDA notified healthcare professionals of a Class I Recall of the Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator. This device has not been approved by FDA, lacks safety and effectiveness data, and is not manufactured under current good manufacturing practices. The manufacturer has submitted no evidence to FDA to support any of their claims that the product could treat or cure such diseases as cancer, depression, infection and pain. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device.

[December 15, 2008 - News Release - FDA]
[October 31, 2008 - Recall Notice - FDA]

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Thoratec HeartMate II Left Ventricular Assist System
Audience: Cardiologists, cardiovascular surgeons, hospital risk managers
[Posted 10/28/2008] Thoratec Corporation notified healthcare professionals of a worldwide correction of the HeartMate II Left Ventricular Assist System (HM II LVAS), of all serial numbers (having Catalogue No. 1355 or 102139), distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump, and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months, and 11.4% at 36 months. Healthcare professionals with patients supported by a HeartMate II LVAS should assess the wear and fatigue of the percutaneous lead and provide proper instruction to patients on the management and care of the lead.

[October 24, 2008 - Press Release - FDA]

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Transvaginal Placement of Surgical Mesh
Audience: Hospital surgical staff, OB/GYN physicians, other healthcare professionals
[Posted 10/21/2008] FDA informed healthcare professionals of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia. FDA provided recommended actions for both physicians and patients to reduce the risks.

[October 21, 2008 - Public Health Notification - FDA]

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Raptiva (efalizumab)
Audience: Dermatological healthcare professionals, patients
[Posted 10/17/2008] FDA notified healthcare professionals of extensive labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections with the use of Raptiva. In addition, the prescribing information will be updated to describe a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in children. Raptiva is not approved for children under 18 years of age.

Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks. Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay. Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug.

Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.

[October 16, 2008 - News Release - FDA]
[October 2008 - Prescribing Information - Genentech]

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Dextroamphetamine Sulfate 5mg Tablets
Audience: Pharmacists, other healthcare professionals, patients
[Posted 10/16/2008] Ethex Corp and FDA notified healthcare professionals of a voluntary recall of three lots of Dextroamphetamine Sulfate 5mg tablets. The product was recalled due to the potential presence of oversized tablets that may contain as much as twice the labeled amount of the active ingredient. Taking a higher than expected dose of Dextroamphetamine Sulfate may be associated with an increased risk of adverse effects such as tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and dry mouth. Consumers and their caregivers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized and should consult their healthcare professional with any questions.

[October 15, 2008 - Press Release - Ethex]

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Over The Counter Cough and Cold Medications
Audience: Pediatric and primary healthcare professionals, consumers
[Posted 10/09/2008] FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state "do not use" in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns.

[October 09, 2008 - News Release - FDA]

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Nebion HLX-8 Magnetic Resonance Device
Audience: Healthcare professionals, consumers
[Posted 10/03/2008] FDA notified healthcare professionals of a Class I Recall of the Nebion HLX-8 Magnetic Resonance Device. The manufacturer of the device made unsupported claims that the product could be used to treat many different medical conditions and diseases such as cancer (including breast, bone, lung, and pancreatic), carpel tunnel syndrome, migraines, premenstrual syndrome, rheumatoid arthritis, ruptured disks, shingles, and sports injuries and sprains. The device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device.

[December 15, 2008 - News Release - FDA]
[October 03, 2008 - Recall Notice - FDA]

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Medtronic INDURA 1P Intrathecal Catheter
Sutureless Pump Connector Revision Kit
Intrathecal Catheter Pump Segment Revision Kit

Audience: Physical medicine and rehabilitation specialists, anesthesia healthcare professionals, hospital surgical service managers
[Posted 10/02/2008] Medtronic and FDA notified healthcare professionals of the Class I Recall of several Medtronic intrathecal catheters and intrathecal catheter revision kits used with the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps that store and deliver parenteral drugs to the intrathecal space. The products were recalled because of potential misconnections of the Medtronic Sutureless Connector Catheters from the catheter port on the pump. These misconnections have resulted in a blockage between the sutureless pump connector and the catheter port on the pump and disconnection from the pump connector. See the FDA Recall Notice for recommendations for healthcare professionals.

[October 01, 2008 - Recall Notice - FDA]

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Statin drugs and amyotrophic lateral sclerosis (ALS)
Audience: Neurologists, cardiologists, consumers
[Posted 09/30/2008] An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The FDA analysis, undertaken after the agency received a higher than expected number of reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use. Results from this study should be available within 6-9 months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.

Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.

[September 29, 2008 - News Release - FDA]

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Epoetin alfa - Early Communication about an Ongoing Safety Review
Audience: Neurological healthcare professionals
[Posted 09/23/2008] FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. The clinical trial utilized doses of epoetin alfa that were considerably higher than the doses recommended for the treatment of anemia as described in the FDA-approved labeling for the product. Over a period of ninety days after the start of the trial, there were more deaths in the group of patients who received epoetin alfa compared to patients who received the placebo (16% versus 9%). Roughly half of all deaths in both groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage (bleeding within the brain) occurring among approximately 4% of patients who received epoetin alfa compared to 1% of patients in the placebo group.

FDA anticipates the receipt of additional data within the next several weeks. As soon as the review of these data is complete, FDA will communicate our conclusions and recommendations to the public. The finding of increased mortality in patients receiving epoetin alfa in the German trial suggests the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials.

[September 26, 2008 - Early Communication about an Ongoing Safety Review - FDA]

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Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10%
Audience: Hospital ER and ICU medical and nursing personnel, risk managers
[Posted 09/23/2008] Ucyclyd Pharma, Inc. informed healthcare professionals of the detection of particulate matter in the Ammonul Injection product. This particulate matter may impact the safe use of Ammonul. To ensure optimal patient care, healthcare providers are being instructed to use a MilIex Durapore GV 33 mm Sterile Syringe Filter (0.22 µm ) during the admixture process when injecting Ammonul into the 10% Dextrose IV bag. Since this particulate matter may not be readily seen on visual inspection, a filter must be employed in all cases regardless of whether particulate matter is seen in the vial. Testing has confirmed the removal of this specific particulate when using this filter to admix Ammonul. Contact Ucyclyd Pharma, 1-888-829-2593, or 1-800-900-6389 -- a representative is available 24 hours, seven days a week.

[September 15, 2008 - Letter - Ucyclyd Pharma, Inc.]

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Tarceva (erlotinib)
Audience: Oncological healthcare professionals
[Posted 09/23/2008] OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Patients with hepatic impairment receiving Tarceva should be closely monitored during therapy and the product should be used with extra caution in patients with total bilirubin >3x ULN. Dosing should be interrupted or discontinued if changes in liver function are severe, such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside the normal range. New information from a pharmacokinetic study in patients with moderate hepatic impairment associated with significant liver tumor burden has been provided in the revised prescribing information, and other recommendations are included in the WARNINGS and DOSAGE AND ADMINISTRATION sections.

[September 2008 - Letter - OSI Pharmaceuticals, Inc. and Genentech, Inc.]
[September 12, 2008 - Label - OSI Pharmaceuticals, Inc. and Genentech, Inc.]

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Phosphocol P 32 (Chromic Phosphate P 32 Suspension)
Audience: Oncologists, other healthcare professionals
[Posted 09/18/2008] Covidien and Mallinckrodt Inc. informed healthcare professionals of important new safety information in prescribing Phosphocol P 32. Phosphocol P 32 is approved for the intracavitary instillation for the treatment of peritoneal or pleural effusions caused by metastatic disease. Phosphocol P 32 may increase the risk for leukemia in certain situations. Two children (ages 9 and 14) with hemophilia developed acute lymphocytic leukemia approximately 10 months after intra-articular injections of Phosphocol P 32 (0.6 and 1.5 mCi total dose). This drug is not indicated in the intra-articular treatment of hemarthroses. Additionally, post marketing experience identified radiation injury (necrosis and fibrosis) to the small bowel, cecum, and bladder following administration of P 32 into the peritoneal cavity. Healthcare professionals should refer to the product's revised prescribing information for updated information regarding the appropriate use of Phosphocol P 32.

[August 29, 2008 - Letter – Covidien]
[August 2008 - Label – Covidien]

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Infant Formula Manufactured in China
Audience: Consumers, pediatricians
[UPDATE 10/03/2008] FDA issued the results of its interim safety and risk assessment that evaluated the melamine exposure in infant formula and in other foods. FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns. FDA continues to advise consumers not to purchase infant formula manufactured in China from internet sites or from other sources and to contact their health care professional if they have questions regarding their infant’s health or if they note changes in their infant’s health status.

[UPDATE 09/22/2008] FDA contacted companies who manufacture infant formula for distribution in the United States and has learned that they are not importing formula or source materials from China. FDA, in conjunction with state and local officials, began a nation-wide investigation to check Asian markets for Chinese-manufactured infant formula and have not found Chinese infant formula present on shelves in these markets. FDA is advising consumers not to purchase infant formula manufactured in China from internet sites or from other sources.

[Posted 09/12/2008] FDA issued a Health Information Advisory to consumers and healthcare professionals regarding milk-based infant formula manufactured in China. The Chinese manufactured infant formula may be contaminated with melamine. Melamine artificially increases the protein profile of milk and can cause kidney diseases. Currently, no Chinese manufacturers of infant formula have fulfilled the requirements to sell this product in the United States. FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. Caregivers should not feed infant formula manufactured in China to infants and should replace any product from China with an appropriate infant formula manufactured in the United States. Individuals should contact their health care professional if they have questions regarding their infant’s health or if they note changes in their infant’s health status.

[October 03, 2008 - News Release - FDA]
[September 20, 2008 - Statement - FDA]
[September 12, 2008 - News Release – FDA]

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LifePak CR Plus Automated External Defibrillators
Audience: Emergency medical personnel, other healthcare professionals
[UPDATE 09/16/2008] Recall classified by FDA as Class I. See the Recall notice for product numbers affected by this recall.

[Posted 09/11/2008] Physio Control, Inc., issued a recall of LifePak CR Plus Automated External Defibrillators (AED), used by emergency or medical personnel to treat adults in cardiopulmonary arrest. The product was recalled because the AED instructs the responder by voice prompts to press the shock button which is not visible because it is covered, thereby making the responder unable to provide shock therapy. The AED device should be removed from service, or the manufacturer-provided diagram should be consulted to remove and discard the shock button cover.

[September 11, 2008 - Recall Notice – FDA]

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Rituxan (rituximab)
Audience: Oncologists, rheumatologists, other healthcare professionals, consumers
[Posted 09/11/2008] Genentech informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study. The patient developed a JC virus infection with resultant PML and death 18 months after taking the last dose of Rituxan. Healthcare professionals treating patients with Rituxan should consider PML in any patient presenting with new onset neurologic manifestations. Additionally, consultation with a neurologist, brain MRI and lumbar puncture should be considered as clinically indicated.

[September 2008 - Letter – Genentech]
[September 2008 - Label – Genentech, Biogen Idec]

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Disposable Battery Operated Lavage System (BOLS)
Audience: Operating room, outpatient and emergency room supervisory staff and physicians, risk managers
[Posted 09/08/2008] FDA notified healthcare professionals about the potential for sparks, fires, toxic fumes, and explosions when disposable battery operated lavage systems’ (BOLS) cables are cut. BOLS are used in the OR, ER, burn units, and nursing units. The cutting of the battery pack's cable can lead to a short circuit, causing the batteries to discharge rapidly, producing intense heat and flammable gases with a resulting explosion that expels flammable gases and toxic chemicals endangering both patients and staff. Recommendations for avoiding this risk are provided in the medical device safety alert.

[September 04, 2008 - Medical Device Safety (Reprinted Article) – FDA]

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Tumor necrosis factor-alpha blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)
Audience: Rheumatological, gastroenterological and infectious disease healthcare professionals
[Posted 09/04/2008] FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, such as fever, malaise, weight loss, sweats, cough, dypsnea, and/or pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses.  For patients at risk of histoplasmosis and other invasive fungal infections, clinicians should consider empiric antifungal treatment until the pathogen(s) are identified. 

[September 4, 2008 - Information for Healthcare Professionals - FDA]
[September 4, 2008 - Press Release - FDA]

Previous MedWatch Alerts:

[June 3, 2008]

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Pacific Consolidated brand Mobile Oxygen Storage Tank
Audience: Emergency healthcare professionals, military emergency/disaster/field hospital/aviation personnel
[Posted 08/28/2008] Pacific Consolidated Industries, LLC, and FDA notified healthcare professionals of the Class I Recall of the Mobile Oxygen Storage Tank manufactured and distributed between January - March 2007, because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing. The mobile oxygen storage tank is used in military aircraft for treating wounded patients and in disaster areas to quickly supply oxygen to patients. Facilities with the Mobile Oxygen Storage Tank should keep the device in quarantine until arrangements are made to ship the device back to the manufacturer.

[August 28, 2008 - Recall Notice - FDA]

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Tysabri (natalizumab)
Audience: Neurologists, other healthcare professionals, patients
[Posted 08/25/2008] FDA informed healthcare professionals of two new cases of progressive multifocal leukoencephalopathy (PML) in European patients receiving Tysabri monotherapy for multiple sclerosis for more than one year. PML, which is usually fatal, is a known risk of Tysabri treatment, but previous cases in patients with multiple sclerosis were seen in combination with other immunomodulatory therapies. Approximately 39,000 patients have received treatment with Tysabri worldwide, with approximately 12,000 patients receiving treatment for a least one year. No new cases have been seen in the US, where about 7,500 patients have received the drug for greater than one year and approximately 3,300 patients have received the drug for at least one and one-half years. In the U.S., Tysabri is available only to patients with relapsing multiple sclerosis or Crohn's disease who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under this program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections. While the two patients who developed PML were on monotherapy, the FDA still believes that Tysabri monotherapy may confer a lower risk of PML than when Tysabri is used together with other immunomodulatory medications. Prescribing information for Tysabri will be revised to include information informing prescribers and patients that cases of PML have occurred in patients taking Tysabri as monotherapy. Healthcare professionals should continue to monitor patients for sign and symptoms of PML. Additionally, Tysabri should not be infused if PML is suspected.

[August 25, 2008 - Information for Healthcare Professionals - FDA]

Previous MedWatch Alert:

[February 27, 2008]

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Ezetimibe/Simvastatin (marketed as Vytorin)
Simvastatin (marketed as Zocor)
Ezetimibe (marketed as Zetia)

Audience: Endocrinologists, cardiologists, other healthcare professionals, patients
[Posted 08/21/2008] FDA informed healthcare professionals that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and a potentially increased incidence of cancer. Vytorin is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the liver and inhibit the absorption of cholesterol in the intestine to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events. Recently, FDA obtained preliminary results from the SEAS trial. The clinical trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular events in individuals with aortic stenosis. A lower overall cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were diagnosed with and died from all types of cancer combined when compared to placebo during the 5-year study.

FDA anticipates receiving a final SEAS study report in about 3 months and the Agency's review and evaluation of the clinical trial data and other relevant information should take approximately 6 months. FDA will communicate its conclusions and recommendations at that time. Healthcare professionals and caregivers should continue to monitor patients taking Vytorin and report side effects from the use of this drug to the Agency.

[August 21, 2008 - Early Communication about an Ongoing Safety Review - FDA]

Previous MedWatch Alerts:

[January 25, 2008]

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Boston Scientific NexStent Monorail
NexStent Carotid Stent and Monorail Delivery System

Audience: Cardiologists, hospital risk managers
[Posted 08/14/2008] Boston Scientific and FDA informed healthcare professionals and patients of the Class I Recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008. The device is used in patients to treat a blockage in carotid artery disease. The product was recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure. This could lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip. This recall does not affect stents that have already been implanted. Patients should contact their healthcare professional if they have any questions.

[August 14, 2008 - Recall Notice - FDA]

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Vivitrol (naltrexone)
Audience: Primary healthcare physicians, internists, other healthcare professionals
[Posted 08/12/2008] FDA informed healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone. Naltrexone is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. Naltrexone is administered as an intramuscular gluteal injection and should not be administered intravenously, subcutaneously, or inadvertently into fatty tissue. Physicians should instruct patients to monitor the injection site and contact them if they develop pain, swelling, tenderness, induration, bruising, pruritus, or redness at the injection site that does not improve or worsens within two weeks. Physicians should promptly refer patients with worsening injection site reactions to a surgeon. Read the FDA recommendations for healthcare professionals to consider regarding the use of Naltrexone injection.

[August 12, 2008 - Drug Information Page - FDA]
[August 12, 2008 - Information for Healthcare Professionals - FDA]

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Simvastatin Used With Amiodarone
Audience: Cardiologic healthcare professionals, pharmacists, other healthcare professionals
[Posted 08/08/2008] FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone.

[August 08, 2008 - Drug Information Page - FDA]
[August 08, 2008 - Information for Healthcare Professionals - FDA]

[Labels - Simvastatin - DailyMed]
[Labels - Amiodarone - DailyMed]

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Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software)
Audience: Cardiothoracic healthcare professionals, perfusionists, hospital risk managers, biomedical engineers
[Posted 08/01/2008] Levitronix and FDA notified healthcare professionals of a Class 1 recall of the Levitronix CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles manufactured by Levitronix, GmbH, Zurich, Switzerland and distributed from January, 2001 through March, 2008. The Blood Pumping System is used to provide short-term extracorporeal circulatory support during cardiac and other types of surgeries. This device temporarily replaces the function of the heart and lungs in order to maintain the appropriate circulation of blood and oxygen levels in the body during the surgical procedure. A July 24, 2008 Levitronix device correction letter informed physicians not to use Valleylab Force FX-C or SSE2L electrosurgery devices with the CentriMag Blood Pumping System because use may result in stoppage of the pump and may cause serious injury or death. This recall action is an interim fix while the firm further investigates the source of the problem.

[August 01, 2008 - Recall Notice - FDA]
[July 24, 2008 - Letter - Levitronix] Adobe Acrobat pdf format

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Viapro 375mg Capsules
Audience: Consumers, healthcare professionals
[Posted 07/31/2008] EG Labs, LLC, notified consumers and healthcare professionals not to buy or use Viapro 375mg Capsules because one lot of the product was found to contain a potentially harmful undeclared ingredient, thio-methisosildenafil, an analog of sildenafil, a FDA approved product used to treat erectile dysfunction in men to enhance sexual performance. The undeclared ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take products containing nitrates. Consumers who have this product should discontinue using it and consult their healthcare professional if they experience any problems that may be related to taking Viapro.

[July 23, 2008 - Press Release - FDA]

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Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)
Audience: Oncologists, other healthcare professionals
[UPDATE 12/02/2008] FDA issued Q&As for recently approved Medication Guides. The Medication Guides were developed to provide patients with important information about the risks of using ESAs. The information in the Medication Guides may affect a patient’s decision to take the drug and it gives patients a starting point for discussion with their healthcare provider about the medical decision to prescribe an ESA.

[UPDATE 08/08/2008] Amgen, Ortho Biotech letter added.

[Posted 07/31/2008] FDA informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs). The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated. Additional revisions to prescribing information that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure and when to initiate and discontinue ESA dosing will be forthcoming. FDA continues to encourage healthcare professionals to discuss with their patients before starting or continuing therapy with ESAs, the benefits of treatment with ESAs and the potential and demonstrated risks of ESAs for thrombovascular events, shortened time to tumor progression or recurrence, and shortened survival time.

[December 02, 2008 - Q&As on Medication Guides - FDA]
[November 2008 - Medication Guides: Aranesp, Epogen, Procrit] Adobe Acrobat pdf format
[August 07, 2008 - Letter - Amgen, Ortho Biotech] Adobe Acrobat pdf format
[July 30, 2008 - Follow Up to Ongoing Safety Review - FDA]
[July 30, 2008 - Label - Aranesp] Adobe Acrobat pdf format
[July 30, 2008 - Label - Procrit] Adobe Acrobat pdf format
[July 30, 2008 - Label - Epogen] Adobe Acrobat pdf format

Previous MedWatch Alerts:

[03/12/2008]
[01/03/2008]

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Mitoxantrone Hydrochloride (marketed as Novantrone and generics)
Audience: Neurological and Oncological healthcare professionals, risk managers
[Posted 07/29/2008] FDA reminded health care professionals who treat patients with mitoxantrone about recommendations that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone. FDA offered additional recommendations for cardiac monitoring to detect late-occurring cardiac toxicity, and provided information for patients with multiple sclerosis who receive the drug.

These recommendations were established in 2005 in response to post-marketing reports and case reports in the medical literature that described decreases in LVEF or frank congestive heart failure in patients with MS who had received cumulative doses of mitoxantrone that were lower than 100 mg/m2. Since that time, FDA has received information from a post-marketing safety study that demonstrated there is poor adherence to these recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to cardiac monitoring recommendations for patients with MS.

[July 29, 2008 - Information for Healthcare Professionals - FDA]
[March 2005 - Label - Novantrone - Serono, Inc.]

Previous MedWatch Alerts:

[05/24/2005]

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Abacavir (marketed as Ziagen) and Abacavir-containing Medications
Audience: Infectious disease and medical genetics healthcare professionals
[Posted 07/24/2008] FDA informed healthcare professionals that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701. FDA reviewed data from two studies that support a recommendation for pre-therapy screening for the presence of the HLA-B*5701 allele and the selection of alternative therapy in positive subjects. Genetic tests for HLA-B*5701 are available and all patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with abacavir or abacavir-containing medications. Development of clinically suspected abacavir HSR requires immediate and permanent discontinuation of abacavir therapy in all patients, including patients negative for HLA-B*5701.

[July 24, 2008 - Information for Healthcare Professionals - FDA]

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Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)
Audience: Radiological healthcare professionals, cardiologists, hospital risk managers
[Posted 07/17/2008] FDA is updating healthcare professionals about recent changes made to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information for micro-bubble contrast agents, a sterile suspension of perflutren gas microspheres, indicated for use in certain patients with suboptimal echocardiograms, to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.These changes reflect conclusions of FDA reviews of information received following the addition of new Contraindications and Warnings in October 2007. The revised Boxed Warning and Warnings highlight the risk of serious cardiopulmonary reactions during or within 30 minutes following the administration of these products and recommend that high risk patients with pulmonary hypertension or unstable cardiopulmonary conditions be closely monitored during and for at least 30 minutes post administration of these contrast agents. In addition, several of the Contraindications that were added to the labeling in October, 2007 were removed because FDA determined that, in some patients, the benefits from the diagnostic information obtained through the use of Definity or Optison may outweigh the risk for serious cardiopulmonary reactions, even among some patients at particularly high risk for these reactions.

[July 17, 2008 - Information for Healthcare Professionals - FDA]
[June 2008 - Dear Healthcare Professional Letter - GE]
[May 2008 - Dear Healthcare Professional Letter - Lantheus Medical Imaging]

Previous MedWatch Alerts:

[10/12/2007]

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Electronic Medical Devices
Audience: Radiologists, surgeons, hospital risk managers, other healthcare professionals
[Posted 07/16/2008] FDA informed healthcare professionals of the possibility that x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction. Most patients with electronic medical devices undergo CT scans without any adverse consequences. However, the Agency has received a small number of reports of adverse events in which CT scans may have interfered with electronic medical devices, including pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps. FDA is continuing to investigate the issue and is working with the manufacturer to raise awareness in the healthcare community. See the FDA Public Health Notification for a description of adverse event reports and recommendations regarding reducing the potential risk to patients.

[July 14, 2008 - Public Health Notification - FDA]

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Sodium Polystyrene Sulfonate Suspension
Audience: Pharmacists, hospital risk managers, other healthcare professionals
[Posted 07/16/2008] Roxane Laboratories, Inc. informed healthcare professionals of the recall of two lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; lot 856396A Exp April 2010, and lot 856693A Exp May 2010), a product used to treat hyperkalemia. A sample of one of the affected lots tested positive for a strain of yeast, which could potentially affect immunocompromised patients. Symptoms of a yeast infection range from thrush, skin rash, and blood infections. If patients develop an infection they should consult their physician. Pharmacists should determine if any of the referenced product has been dispensed and retrieve it. Additionally, pharmacists and wholesalers of the product should discontinue distribution and use of the referenced lots immediately and contact the manufacturer regarding returning the product.

[July 14, 2008 - Recall - Roxane Laboratories, Inc.]

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Avastin (bevacizumab)
Audience: Oncologists, other healthcare professionals
[Posted 07/14/2008] Genentech, Inc. informed healthcare professionals of reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving Avastin in combination with sunitinib malate. Avastin is not approved for use in combination with sunitinib malate and this combination is not recommended. Twenty-five patients were enrolled in a Phase I dose-escalation study combining Avastin and sunitinib malate. The study consisted of 3 cohorts using a fixed dose of Avastin at 10mg/kg/IV every 2 weeks and escalating doses of sunitinib that included 25, 37.5, and 50 mg orally daily given in a 4 weeks on/ 2 weeks off schedule. Five of 12 patients at the highest sunitinib dose level exhibited laboratory findings consistent with MAHA. Two of these cases were considered severe with evidence of thrombocytopenia, anemia, reticulocytosis, reductions in serum haptoglobin, schistocytes on peripheral smear, modest increases in serum creatinine levels, and severe hypertension, reversible posterior leukoencephalopathy syndrome, and proteinuria. The findings in these two cases were reversible within three weeks upon discontinuation of both drugs without additional interventions. Healthcare professionals should report cases of MAHA or any serious adverse events suspected to be associated with the use of Avastin.

[July 11, 2008 - Dear Healthcare Professional Letter - Genentech]

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Herceptin 440 mg Vials and BWFI Diluent
Audience: Healthcare professionals
[Posted 07/10/2008] Genentech informed healthcare professionals that an increased number of complaints were received regarding damaged and broken vials of Herceptin 440 mg and BWFI (bacteriostatic water for injection) diluent. The affected vials are NDC# 50242-0134-68, List # 15534. There is a risk that damaged vials may lead to a loss in sterility, which can cause infections in patients.

Healthcare professionals should inspect cartons of the product for signs of leakage, cracks and other damage to the vials, observe the vials during reconstitution, and check for loss of vacuum in the vials. See the manufacturer's letter for specific details and recommendations, including instructions in the event a compromised vial is discovered.

[June 28, 2008 - Dear Healthcare Professional Letter - Genentech]

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Fluoroquinolone Antimicrobial Drugs
Audience: Healthcare professionals, consumers
[Posted 07/08/2008] FDA notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use.

Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria.

[July 08, 2008 - Drug Information Page - FDA]
[July 08, 2008 - Information for Healthcare Professionals - FDA]
[July 08, 2008 - News Release - FDA]

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Rize 2 The Occasion Capsules
Rose 4 Her Capsules

Audience: Consumers, healthcare professionals
[UPDATE 07/30/2008] Jack Distribution, LLC, announced a nationwide recall of all lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. Lab analysis by FDA of samples of random lots found the product contains a potentially harmful, undeclared ingredient, thiomethisosildenafil, an analog of sildenafil, the active ingredient of a FDA-approved drug used for erectile dysfunction.

[Posted 07/02/2008] Jack Distribution, LLC issued a voluntary nationwide recall of selected lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, marketed as dietary supplements. The products were recalled because certain lots contained thiomethisosildenafil, an undeclared ingredient that is an analog of sildenafil, a FDA-approved drug used for Erectile Dysfunction. This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers who have one of the above products should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking the products. See the manufacturer's press release for the specific lot numbers of the recalled products.

[July 28, 2008 - Press Release - Jack Distribution, LLC]
[July 01, 2008 - Press Release - Jack Distribution, LLC]

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Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
Audience: Orthopedic surgeons, neurosurgeons, hospital risk managers, surgical service staff
[Posted 07/02/2008] FDA informed healthcare professionals of reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine. The safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use. There have been at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. FDA recommends that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies.

FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of rhBMP, you should follow the reporting procedure established by your facility. Reporting adverse events is everyone’s responsibility, even if the event involves off-label use of medical devices.

[July 01, 2008 - Public Health Notification - FDA]

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2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product
Audience: Hospital risk managers, pharmacists
[Posted 06/30/2008] Sage Products informed healthcare professionals of the voluntary recall of limited lots of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation product. The product was recalled because certain lots were found positive for Burkholderia cepacia (B. cepacia). B. cepacia poses little medical risk to healthy people. However, people who have certain health problems such as a weakened immune system or chronic lung diseases, particularly cystic fibrosis (CF) may be more susceptible to infections with B. cepacia. This organism is a known cause of infections in hospitalized patients and its effects range from no symptoms to serious respiratory infections, especially in patients with CF.

The product was distributed to U.S. hospitals and medical centers nationwide and was shipped between 4/28/08 and 6/19/08. Healthcare professionals should stop using the product and coordinate the return of the product with the manufacturer.

[June 27, 2008 - Press Release - Sage Products]

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Antipsychotics, Conventional and Atypical
Audience: Neuropsychiatric and geriatrics healthcare professionals
[Posted 06/16/2008] FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section.

[June 16, 2008 - Information for Healthcare Professionals - FDA]
[June 16, 2008 - News Release - FDA]

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Morphine Sulfate 60 mg Extended Release Tablets
Morphine Sulfate 30 mg Extended Release Tablets
Audience: Pharmacists, other healthcare professionals
[UPDATE 06/16/2008] Additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, were recalled due to the possible presence of oversized tablets. The recalled lots were distributed by ETHEX Corporation under an “ETHEX” label between June 2006 and May 2008. 

[Posted 06/10/2008] ETHEX Corporation notified healthcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. Opioids such as morphine have life-threatening consequences if overdosed. Consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness, and may be less likely to determine that a tablet is overweight or oversized than an unimpaired individual. If consumers have any questions about the recall, they should call their physician, pharmacist, or other health care provider.

[June 13, 2008 - Press Release - ETHEX Corp.]
[June 09, 2008 - Press Release - ETHEX Corp.]

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Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)
Audience: Rheumatologists, gastroenterologists, oncologists, other healthcare professionals
[Posted 06/03/2008] FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients.

[June 04, 2008 - Early Communication About an Ongoing Safety Review of TNF Blockers - FDA]

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Calcilo XD Low-Calcium & Vitamin D-Free Infant Formula With Iron Powder
Audience: Consumers, pediatricians, other healthcare professionals
[Posted 06/02/2008] Abbott notified consumers and healthcare professionals of the recall of two lots of Calcilo XD Low-Calcium/vitamin D-Free Infant Formula with Iron powder, a low-calcium and Vitamin D-free infant formula specifically designed for the nutrition support of infants and children with hypercalcemia. The product, distributed in the United States between 06/06/06 and 04/17/08, is being recalled because small amounts of air may have entered the can, resulting in product oxidation. Consumption of highly oxidized foods can cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Parents should contact their healthcare professional if they have any questions or concerns.

[May 30, 2008 - Press Release - FDA]

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Viril-ity Power (VIP) Tablets
Audience: Consumers, healthcare professionals
[Posted 05/30/2008] International Pharmaceuticals, Ltd. and FDA notified consumers and healthcare professionals that the company is recalling all supplement products sold under the brand name of Viril-ity Power (VIP) Tablets. The product is being recalled because one lot was found to contain a potentially harmful undeclared ingredient, hydroxyhomosildenafil, an analog of sildenafil. Sildenafil is the active ingredient in Viagra, an FDA-approved drug used for erectile dysfunction. The undeclared ingredient may interact with nitrates found in some prescription drugs (such as Nitroglycerin) and may lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates. Consumers who have Viril-ity Power (VIP) Tablets should stop using it immediately and contact their healthcare professional if they experience any problems that may be related to taking this product.

[May 29, 2008 - Press Release - International Pharmaceuticals, Ltd.]

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Mommy's Bliss Nipple Cream
Audience: Nursing mothers, pediatricians, other healthcare professionals
[Posted 05/29/2008] FDA informed consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. The product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. Potentially harmful ingredients in the product are chlorphenesin and phenoxyethanol. Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause slow or shallow breathing in infants. Phenoxyenthanol, a preservative that is primarily used in cosmetics and medications, can also depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants. Mothers and caregivers should seek immediate medical attention if their child shows signs and symptoms of decreases in appetite, difficulty in awakening, limpness of extremities or a decrease in an infant's strength of grip and a change in skin color.

[May 23, 2008 - News Release - FDA]

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Xiadafil VIP Tablets
Audience: Consumers, healthcare professionals
[Posted 05/27/2008] FDA alerted consumers and healthcare professionals not to buy or use Xiadafil VIP Tablets sold in bottles of 8 tablets (Lot #6K029) or blister cards of 2 tablets (Lot# 6K029-SEI). The product is marketed as a dietary supplement and is promoted and sold over the internet for sexual enhancement and to treat erectile dysfunction (ED). The product contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Xiadafil VIP Tablets contain hydroxyhomosildenafil, an analog of sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for ED. The undeclared ingredient may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have used the product should discontinue use immediately and consult their healthcare professional if they have experienced any adverse events that they believe may be related to the use of this product.

[May 27, 2008 - News Release - FDA]

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Solodyn (minocycline HCL) Extended Release Tablets 90 mg
Audience: Pharmacists, other healthcare professionals
[Posted 05/19/2008] Medicis and FDA notified healthcare professionals of the recall of lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of Solodyn Extended Release Tablets. The product was recalled because one of the bottles contained Azasan (azathioprine tablets) 75mg instead of Solodyn 90mg Tablets. Azasan is an immunosuppressive agent used in transplant patients to prevent kidney rejection and for the treatment of rheumatoid arthritis. Taking Azasan instead of Solodyn presents a health hazard and safety risk to patients. Side effects associated with the use of Azasan, particularly in the elderly, include myelosuppression, infection, bleeding, chills, nausea, vomiting and diarrhea. Joint and muscle pain are also common side effects. Additionally, unanticipated interactions with other drugs may also lead to serious adverse events. The recall is limited to the lots referenced above. Healthcare professionals are urged to check their inventory and pull the referenced lot numbers from their stock and make arrangements with the manufacturer to return the product.

[May 16, 2008 - Press Release - Medicis]

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Mycophenolate Mofetil [MMF] (marketed as CellCept)
Mycophenolic Acid [MPA] (marketed as Myfortic)
Inosine Monophosphate Dehydrogenase Inhibitors (IMPDH) Immunosuppressants

Audience: Transplantation specialists, infectious disease specialists, other healthcare professionals
[Posted 05/16/2008] FDA is aware of reports of infants born with serious congenital anomalies, including microtia and cleft lip and palate, following exposure to mycophenolate mofetil (MMF) during pregnancy. MMF, the active drug substance in CellCept, is an ester of the active metabolite mycophenolic acid (MPA), the active drug substance in Myfortic. In most cases, the mothers were taking MMF following an organ transplant to prevent organ rejection. However, some mothers taking MMF were being treated for immune-mediated conditions such as systemic lupus erythematosus (SLE) and erythema multiforme. Treatment began before their pregnancies and continued into the first trimester or until the pregnancy was detected. MMF and MPA increase the risk of spontaneous abortion in the first trimester and can cause congenital malformations in the offspring of women who are treated during pregnancy.

FDA is continuing to work with the manufacturers of these drug products to develop and implement means to mitigate the risks of fetal exposure. See the FDA Healthcare Professional Information Sheet containing considerations and recommendations for clinicians prior to prescribing MMF or MPA to women of childbearing potential.

[May 16, 2008 - Healthcare Professional Sheet - FDA]

Previous MedWatch Alerts:

[04/10/2008]
[11/27/2007]
[10/29/2007]
[02/22/2007]

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Cardinal Alcohol-Free Mouthwash
Audience: Consumers, hospital and nursing home risk managers, healthcare professionals
[UPDATE 05/19/2008] Hydrox Labs issued a voluntary recall of another lot of Alcohol-Free Mouthwash because samples of the product tested were positive for Burkholderia cepacia (B. cepacia). The affected product lot number is 26230.

[Posted 05/06/2008] Hydrox Labs issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash because the product was found to contain Burkholderia cepacia (B. cepacia). The affected product lot number is 26228. B. cepacia poses little medical risk to healthy individuals. However, people who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with this organism. Consumers and facilities with the recalled alcohol-free mouthwash should stop using the product and contact Cardinal Health for instructions on how to return the product.

[May 16, 2008 - Press Release - Hydrox Labs]
[May 02, 2008 - Press Release - Hydrox Labs]

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Enbrel (etanercept)
Audience: Rheumatologists, dermatologists, other healthcare professionals, patients
[Posted 05/01/2008] Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribing information for Enbrel. The revisions include a BOXED WARNING about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel. Infections have included bacterial sepsis and tuberculosis. The ADVERSE REACTIONS section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel. Healthcare professionals should screen patients for latent tuberculosis infection before beginning Enbrel. Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with the drug. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, Enbrel should be discontinued.

[March 14, 2008 - Dear Healthcare Professional Letter - Amgen/Wyeth] Adobe Acrobat pdf format
[February, 2008 - Label - Amgen/Wyeth] Adobe Acrobat pdf format


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Digitek (digoxin tablets, USP)
Audience: Cardiologists, family physicians, pharmacists, other healthcare professionals, patients
[Posted 04/28/2008] Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions.

[April 25, 2008 - Press Release - Actavis Totowa LLC]

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Herbal Science International, Inc. Dietary Herbal Supplements
Audience: Consumers, healthcare professionals
[Posted 04/14/2008] Herbal Science International, Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers. FDA has long regarded dietary supplements containing ephedra, a botanical that contains ephedrine alkaloids, as a potential health hazards because the alkaloid raises blood pressure and otherwise stress the circulatory system. These effects are linked to adverse health effects like heart attacks and stroke. FDA issued a rule in February 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of illness or injury.

Two of the recalled products contain aristolochic acid which is a potent carcinogen and nephrotoxin. This chemical can cause serious kidney damage and has been associated with several occurrences of kidney failure. The twelfth recalled product contains human placenta, an ingredient which may transmit disease. Dietary supplements that contain human placenta may not be lawfully marketed in the United States. No illnesses have been reported in connection with the recalled products and distribution of all of the products has ceased. Consumers should immediately discontinue use of the recalled products and return the product(s) to their place of purchase.

[April 10, 2008 - Press Release - Herbal Science International]

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CellCept (mycophenolate mofetil)
Myfortic (mycophenolate acid)

Audience: Transplantation specialists, infectious disease specialists, other healthcare professionals
[Update] Novartis informed healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the Myfortic prescribing information. The changes are based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with Myfortic.

[Update] Roche Laboratories informed healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the CellCept prescribing information. The changes are based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with CellCept.

[Posted 04/10/2008] FDA informed healthcare professionals that the Agency is investigating a potential association between the use of CellCept and Myfortic, medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease. PML is a rare disorder that affects the central nervous system usually occurring in patients with immune systems suppressed by disease or medicines. FDA is reviewing data submitted by Roche, including postmarketing reports it has received of PML in patients who took CellCept or Myfortic, and the proposed revisions to the CellCept prescribing information.  FDA has asked Novartis, the maker of Myfortic, for data on PML cases and to revise the Myfortic prescribing information to include the same information about PML included in the CellCept prescribing information.  FDA anticipates it may take about 2 months to complete its review of the postmarketing reports and the proposed revisions to the prescribing information.  As soon as the review is completed, FDA will communicate the conclusions and recommendations to the public.

Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic.

[June 2008 -- Dear Healthcare Professional Letter - Novartis]
[June 2008 -- Dear Healthcare Professional Letter - Roche]
[April 10, 2008 - Communication About an Ongoing Safety Review - FDA]

Previous MedWatch Alerts:

[11/27/2007]
[10/29/2007]
[02/22/2007]

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Neupro (rotigotine transdermal system)
Audience: Neurologists, other healthcare professionals, patients
[Posted 04/09/2008] Schwarz Pharma informed healthcare professionals and patients of the recall of Neupro, a transdermal delivery system worn on the skin and used to treat early stage Parkinson’s disease, at the end of April 2008, because of the formation of rotigotine crystals in the patches. When the drug crystallizes, less drug is available to be absorbed through the skin and the efficacy of the product may vary. Healthcare professionals should not initiate any new patients on Neupro and should begin to down-titrate all patients currently using the product per the guidelines in the product labeling. Patients should NOT abruptly discontinue therapy. Abrupt withdrawal of dopamine agonists has been associated with a syndrome resembling neuroleptic malignant syndrome or akinetic crises.

[April 8, 2008 - Drug Shortage Information - FDA.]

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Exubera (insulin human rDNA origin) Inhalation Powder
Audience: Endocrinologists, pulmonologists, pharmacists, patients
[Posted 04/09/2008] Pfizer informed healthcare professionals and patients of updated safety information in the WARNINGS section of prescribing information for Exubera, a short-acting insulin you breathe in through your mouth using the Exubera inhaler that helps to control high blood sugar in adults with diabetes. There have been 6 newly diagnosed cases of primary lung malignancies in clinical trials among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking. Because of limited availability of Exubera, healthcare professionals should seek alternative treatment options to maintain patients' glycemic control.

[April 9, 2008 - Dear Healthcare Professional Letter - Pfizer, Inc.] Adobe Acrobat pdf format
[April 9, 2008 - Dear Patient Letter - Pfizer, Inc.] Adobe Acrobat pdf format

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Cubicin (daptomycin for injection)
Audience: Infectious disease healthcare professionals, hospital risk managers, and nursing service managers
[Posted 04/09/2008] Cubist Pharmaceuticals, Inc. informed healthcare professionals that a potentially significant impurity, 2-mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. MBT is used in the manufacture of rubber and has been reported to leach from rubber stoppers and syringe components into medicinal products in the past. Cutaneous exposure to MBT has been associated with dermal sensitization, and chronic administration of MBT to laboratory rodents has been associated with an increased risk of certain tumors. No MBT has been identified in reconstituted Cubicin in other standard types of infusion systems that have been tested. Healthcare professionals are advised to discontinue using ReadyMED elastomeric infusion pumps with Cubicin until the issue has been addressed.

[April, 2008 - Letter - Cubist Pharmaceuticals, Inc.] Adobe Acrobat pdf format

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Heparin Sodium USP Pre-Filled Syringes
Audience: Surgeons, hospital risk managers, pharmacists, other healthcare professionals
[Posted 04/02/2008] Covidien notified healthcare professionals of a voluntary recall of certain lots of Heparin Sodium USP because two lots of the product acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue. See the manufacturer's press release for the list of specific lots of the product affected by the recall. Use of the recalled product should be discontinued immediately. Patients should contact their physician if they experience any problems associated with the use of the product.

[March 28, 2008 - Press Release - Covidien] Adobe Acrobat pdf format

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Relenza (zanamivir)
Audience: Pediatric and infectious disease healthcare professionals
[Posted 04/01/2008] GlaxoSmithKline informed healthcare professionals of changes to the WARNINGS AND PRECAUTIONS sections of prescribing information for Relenza regarding information from postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury in patients with influenza who are receiving neuraminidase inhibitors, including Relenza. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of Relenza to these events has not been established. Influenza can be associated with a variety of neurologic and behavioral symptoms which can include seizures, hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.

Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.

[March, 2008 - Letter - GlaxoSmithKline] Adobe Acrobat pdf format
[Feb, 2008 - Label - GlaxoSmithKline] Adobe Acrobat pdf format

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Total Body Formula, Total Body Mega Formula
Audience: Consumers, healthcare professionals
[UPDATE 05/01/2008] FDA notified healthcare professionals and consumers that the Agency's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" detected hazardous amounts of chromium in addition to selenium. Excessive consumption of chromium can cause fatigue, muscle cramps, hyperactivity, hypoglycemia, renal failure and liver toxicity. Excessive chromium intake can also interfere with certain medications. FDA continues to investigate how excessive amounts of selenium and chromium got into the products.

[UPDATE 04/10/2008] The FDA notified healthcare professionals and patients that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." Analyses of samples by FDA have found most of the samples contain extremely high levels of selenium -- up to 200 times the amount of selenium indicated on the labels of the products. The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products. The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue. Consumers should stop taking the products and consult their healthcare professional if they experience any adverse events associated with the use of the products.

[Posted 03/28/2008] The FDA notified consumers of a recall of, and advised them not to purchase or consume, the liquid dietary supplement products Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The Florida Department of Health recently provided reports to the FDA on 23 individuals who experienced serious reactions to these products seven to 10 days after ingestion. In all cases, the reactions included significant hair loss, muscle cramps, diarrhea, joint pain and fatigue. FDA laboratories are analyzing samples of the products to identify the cause of the reactions.

[May 01, 2008 - News Release - FDA]
[April 09, 2008 - News Release - FDA]
[March 27, 2008 - News Release - FDA]

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Ziagen (abacavir)
Videx (didanosine)

Audience: Infectious disease specialists, other healthcare professionals, patients
[Posted 03/27/2008] The FDA issued an Early Communication about recent findings of The Data Collection on Adverse Events of Anti-HIV Drugs Study. Data analyses from this study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking Ziagen (abacavir) or Videx (didanosine) as part of their drug therapy. The study is a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia. Patients in this study are being followed to evaluate the short and long term adverse effects of treatment with anti-HIV drugs. FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until the FDA’s review is complete, health care professionals should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

[March 27, 2008 - Early Communication About an Ongoing Safety Review - FDA]

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Regranex (becaplermin) Gel
Audience: Endocrinologists, other healthcare professionals, patients
[UPDATE 06/06/2008] FDA informed healthcare professionals that a Boxed Warning was added to prescribing information for Regranex that describes an increased risk of death from cancer in patients treated with three or more tubes of Regranex compared with those patients who did not use the product. FDA recommends that Regranex be used only when the benefits can be expected to outweigh the risks.

[Posted 03/27/2008] The FDA is conducting a safety review based on study data suggesting there may be an increased risk of death from cancer in diabetic patients using Regranex (becaplermin) Gel, a skin product used to heal leg and foot ulcers. While the review is ongoing, the FDA recommends health care professionals discuss the potential risks and benefits of using Regranex with their patients.

This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

[June 06, 2008 - Drug Information Page - FDA]
[March 27, 2008 - Communication About an Ongoing Safety Review - FDA]

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Singulair (montelukast)
Audience: Pulmonologists, respiratory therapists, other healthcare professionals, patients
[UPDATE 01/13/2009] FDA provided updated information to its March 2008 Early Communication. FDA is continuing to review clinical trial data to assess other neuropsychiatric events, (mood and behavioral adverse events) related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton). As a result, FDA has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioral adverse events associated with montelukast, zafirlukast, and zileuton.

[Posted 03/27/2008] FDA informed healthcare professionals and patients of the Agency's investigation of the possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a leukotriene receptor antagonist used to treat asthma and the symptoms of allergic rhinitis, and to prevent exercise-induced asthma. Patients should not stop taking Singulair before talking to their doctor if they have questions about the new information. Healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.  Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations.  As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

[January 13, 2009 - Follow-up to the March 27, 2008 Communication - FDA]
[March 27, 2008 - Early Communication About an Ongoing Safety Review - FDA]

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"Blue Steel" and "Hero" Dietary Supplement Products
Audience: Consumers
[Posted 03/25/2008] The U.S. Food and Drug Administration is advising consumers not to purchase or use "Blue Steel" or "Hero" products, marketed nationally as dietary supplements, because these products contain undeclared ingredients, which may dangerously affect a person’s blood pressure level. They are considered unapproved drugs and have not been proven to be safe or effective. These products are promoted and sold over the Internet for the treatment of erectile dysfunction [ED] and for sexual enhancement. They contain undeclared and unapproved substances similar in chemical structure to sildenafil, the active ingredient in an FDA-approved prescription drug for ED. The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels.

[March 25, 2008 - Press Release - FDA]

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B. Braun Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride Injection Solution
Audience: Surgeons, dialysis center staff, hospital risk managers, other healthcare professionals
[Posted 03/21/2008] B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects 23 Finished Product lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada. This product recall was initiated due to a notification received from SPL, disclosing that one lot of Heparin Sodium, USP API acquired by B. Braun has a heparin-like contaminant. FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant.

[March 21, 2008 - Press Release - B. Braun Medical]

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Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps
Audience: Physiatry and Pain management healthcare professionals
[Posted 03/21/2008] FDA and Medtronic notified healthcare professionals of the Class 1 recall of Medtronic Neuromodulation Implantable Infusion Pumps, implantable devices for administering drugs to a specific site in the body to treat pain, spasticity and cancer. The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 16, 2008, Medtronic sent a letter to doctors who implant these devices and/or provide care to patients with the implanted device. The letter described the problem, patient risks, patient management, recommendations and next steps.

[March 21, 2008 - Recall Notice - FDA]
[January, 2008 - Dear Healthcare Professional Letter - Medtronic] Adobe Acrobat pdf format

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Tiotropium (marketed as Spiriva HandiHaler)
Audience: Pulmonary care health professionals and patients
[UPDATE 10/07/2008] FDA informed healthcare professionals that FDA has reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with chronic obstructive pulmonary disease. The preliminary results reported by Boehringer Ingelheim to the FDA showed that there was no increased risk of stroke with tiotropium bromide compared to placebo. 

Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Both studies examined cardiovascular outcomes.

FDA expects to receive the complete report for UPLIFT in November 2008.  Results from this trial will also help to address some issues raised about tiotropium in the two recent publications. Due to the amount of data collected in UPLIFT, a complete review of the results could take several months, at which time FDA will update this communication with the final results of the UPLIFT analysis, as well as all the available data regarding tiotropium and stroke risk.

[Posted 03/18/2008] Boehringer Ingelheim and FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva. This product contains tiotropium bromide and is used to treat bronchospasm associated with chronic obstructive pulmonary disease. Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the safety data from 29 placebo controlled clinical studies (“pooled analysis”).  Based on data from these studies, the preliminary estimates of the risk of stroke are 8 patients per 1000 patients treated for one year with Spiriva, and 6 patients per 1000 patients treated for one year with placebo. This means that the estimated excess risk of any type of stroke due to Spiriva is 2 patients for each 1000 patients using Spiriva over a one year period. 

It is important to interpret these preliminary results with caution. FDA is working with Boehringer Ingelheim to further evaluate the potential association between Spiriva and stroke. FDA has not confirmed these analyses and while pooled analyses can provide early information about potential safety issues, these analyses have inherent limitations and uncertainty that require further investigation using other data sources. Patients should not stop taking Spiriva HandiHaler before talking to their doctor, if they have questions about this new information. This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.

[UPDATE October 07, 2008 - Early Communication about an Ongoing Safety Review - FDA]

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Medtronic AneuRx Stent Graft System
Audience: Vascular surgery healthcare professionals, hospital surgical service managers
[Posted 03/18/2008] FDA issued a Public Health Notification to inform healthcare professionals of an update to earlier FDA safety information on this product. The notification re-emphasizes the need for continued surveillance of patients treated with endovascular grafts, and provides updated information on the mortality risks associated with the use of the AneuRx Stent Graft System to prevent abdominal aortic aneurysm rupture.

[March 17, 2008 - Public Health Notification - FDA]

Previous MedWatch Alerts:

[12/17/2003]
[04/30/2001]

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Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)
Audience: Oncological healthcare professionals
[Posted 03/12/2008] Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of ≥ 12 g/dL.

[March 07, 2008 - Dear Healthcare Professional Letter - Amgen] Adobe Acrobat pdf format

Previous MedWatch Alert:

[11/08/2007]

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Prezista (darunavir)
Audience: Infectious disease healthcare professionals
[UPDATE 3/21/2008] FDA issued a new "Information for Healthcare Professionals" sheet highlighting the addition of hepatotoxicity information to the WARNINGS section of prescribing information for Prezista.

[Posted 03/12/2008] FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. In clinical trials and postmarketing experience, drug induced hepatitis has been reported in patients receiving combination therapy with Prezista/ritonavir. Appropriate laboratory testing should be conducted prior to initiating therapy with Prezista/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of Prezista/ritonavir treatment.

[March 21, 2008 - Information for Healthcare Professionals - FDA]
[March 2008 - Dear Healthcare Professional Letter - Tibotec] Adobe Acrobat pdf format
[February 2008 - Prescribing Information - Tibotec]

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Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension)
Audience: Healthcare professionals, pharmacists, patients
[UPDATE 04/24/2008] Dear Healthcare Professional Letter issued by UCB, Inc.

[Posted 03/11/2008] FDA informed healthcare professionals of life-threatening adverse events and death in patients, including children, who have received Tussionex Pennkinetic Extended-Release Suspension (Tussionex). The reports indicate that healthcare professionals have prescribed Tussionex for patients younger than the approved age group of 6 years old and older, and more frequently than the labeled dosing interval of every 12 hours. Tussionex is contraindicated for use in patients less than 6 years of age because of their susceptibility to life-threatening and fatal respiratory depression.

Patients have administered the incorrect dose due to misinterpretation of the dosing directions, and have used inappropriate devices to measure the suspension. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening and fatal respiratory depression. Prescribers should be familiar with the dosing recommendations of Tussionex before prescribing. In addition, patients and caregivers should use a properly marked measuring device to measure Tussionex to prevent overdose.

[April 16, 2008 - Dear Healthcare Provider Letter - UCB] Adobe Acrobat pdf format
[March 11, 2008 - Drug Information Page - FDA]
[March 11, 2008 - Public Health Advisory - FDA]
[January 2008 - Prescribing Information - UCB] Adobe Acrobat pdf format

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Blood Glucose Meters and Test Strips
Audience: Diabetes healthcare professionals, pharmacists and patients
[Posted 03/11/2008] FDA reminded glucose meter users to only use strips recommended for their specific brand of meter and to read the instructions for use carefully. It is important for users to understand that if they use a test strip that is not recommended for their meter, the device may fail to give results or may generate inaccurate results. While this problem has been identified recently as occurring with a unique meter-strip configuration, FDA recognizes that similar problems can also occur if other brands and models of meters and strips are not used in proper combination.

[March 10, 2008 - News Release - FDA/CDRH/OIVD]

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Unapproved Over The Counter Drugs Marketed for Prevention and Treatment of STDs
Audience: Healthcare professionals, consumers
[Posted 03/06/2008] FDA advised healthcare professionals and consumers that the Agency issued Warning Letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the internet to U.S. consumers for the prevention and treatment of sexually transmitted diseases (STDs). The products are marketed under the names Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus. The products claim to prevent or treat a variety of STDs, including Herpes, Chlamydia, Human Papilloma Virus, cervical dysplasia, and HIV/AIDS. The products pose a serious health threat to unsuspecting consumers who don't know that these products are not FDA approved and have not been proven safe or effective. Consumers who are currently using these products should stop using them immediately and consult their healthcare professional if they have experienced any adverse effects that they suspect are related to the use of these products.

[March 06, 2008 - News Release - FDA]

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Aspire36, Aspire Lite Dietary Supplements
Audience: Consumers, healthcare professionals
[Posted 03/04/2008] Palo Alto Labs and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of two dietary supplements, Aspire36 and Aspire Lite. The products were recalled because they were found to contain Aildenafil in trace amounts and Dimethyl sildenafil thione, an analog of Sildenafil, a drug used to treat erectile dysfunction. The presence of these ingredients in the dietary supplements may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers who have Aspire36 and Aspire Lite in their possession should stop using the products and return any unused product to the place of purchase.

[February 28, 2008 - Press Release - Palo Alto Labs]

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Tamiflu (oseltamivir phosphate)
Audience: Pediatric and infectious disease healthcare professionals
[Posted 03/04/2008, UPDATED 03/04/2008] Roche and FDA informed healthcare professionals of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza.The label has been revised as follows: Influenza can be associated with a variety of neurologic and behavioral symptoms which can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. There have been postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza who were receiving Tamiflu. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made but they appear to be uncommon based on Tamiflu usage data. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of Tamiflu to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.

[February, 2008 - Dear Healthcare Professional Letter - Roche] Adobe Acrobat pdf format
[January, 2008 - Tamiflu Prescribing Information - Roche] Adobe Acrobat pdf format

Previous MedWatch alert:
[November 13, 2006]

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Spiriva (tiotropium bromide inhalation powder) Capsules
Foradil (formoterol fumarate inhalation powder) Capsules

Audience: Pulmonologists, respiratory therapists, pharmacists, other healthcare professionals, patients
[Posted 02/29/2008] FDA informed healthcare professionals and consumers of the correct way to use Spiriva and Foradil inhalation powder capsules. FDA and the American Association of Poison Control Center’s (AAPCC) National Poison Data System have received many reports of patients swallowing Spiriva and Foradil capsules rather than placing the capsules in the inhalation devices. Both products are to be used in the HandiHaler (Spiriva) and Aerolizer (Foradil) devices to deliver the medicine to the lungs to improve breathing in patients with asthma, and in individuals affected by chronic obstructive lung disease and bronchitis. Both products will not treat a patient's breathing condition if the contents of a capsule are swallowed rather than inhaled. Healthcare professionals should discuss with patients how to correctly use the Spiriva HandiHaler or Foradil Aerolizer. See the Public Health Advisory for important information on the correct use of both products.

[February 29, 2008 - Public Health Advisory - FDA]

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Tysabri (natalizumab)
Audience: Neurologists, other healthcare professionals, patients
[Posted 02/27/2008] Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury.

[February, 2008 - Letter - Biogen Idec, Elan] Adobe Acrobat pdf format
[January, 2008 - Prescribing Information - Biogen Idec, Elan] Adobe Acrobat pdf format

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Denture Cleanser Allergic Reactions and Misuse
Audience: Dental healthcare professionals, patients
[Posted 02/26/2008] FDA notified dental healthcare professionals and patients of the risk of serious allergic reactions in users of denture cleansers. These adverse events, including abdominal pain, vomiting, seizures, hypotension and difficulty breathing, have occurred both when the product has been used properly as well as from improper use. These events can occur soon after first use or after years of use. FDA believes that the ingredient responsible for these reactions is persulfate, a known allergen. Persulfates are used in most denture cleansers to help clean and bleach the dentures. FDA has provided specific recommendations for dental healthcare professionals and an 'Advice for Patients' document that can be accessed at the links below.

FDA is recommending that all manufacturers of denture cleansers modify their labeling to include warning information that the product contains persulfates and recommends improving the directions for use on their labeling in order to reduce misuse.

[February 25, 2008 - Public Health Notification - FDA]
[February 25, 2008 - Advice for Patients - FDA]

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Avandia (rosiglitazone maleate)
Audience: Endocrinologists, pharmacists, patients
[Posted 02/26/2008] FDA and GlaxoSmithKline notified pharmacists and physicians of a new Medication Guide for Avandia (rosiglitazone maleate). The FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern. A list of currently approved Medication Guides are available at http://www.fda.gov/cder/Offices/ODS/medication_guides.htm. The Medication Guide and current Prescribing Information for Avandia are provided below.

[February, 2008 - Medication Guide - GlaxoSmithKline] Adobe Acrobat pdf format
[January, 2008 - Prescribing Information - GlaxoSmithKline] Adobe Acrobat pdf format

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Fentanyl transdermal System CII Patches
Audience: Pain management specialists, risk managers, other healthcare professionals, patients
[UPDATED 08/12/2008] Watson Pharmaceuticals, Inc., issued a voluntary recall of one lot of 75mcg/hr Fentanyl Transdermal System patches (lot 92461850; Expiration Date: 8/31/2009) sold in the United States between January 30, 2008, and March 19, 2008. The product was recalled because a small number of the patches were leaking and may expose patients or caregivers directly to fentanyl gel.

[UPDATED 03/03/2008] Actavis Inc. has voluntarily recalled of all lots of Fentanyl Transdermal System CII patches sold in the United States.

[Posted 02/19/2008] Actavis Inc. announced a nationwide recall of certain lots of Fentanyl transdermal system CII Patches sold in the United States and labelled with an Abrika or Actavis label. The product may have a fold-over defect which can cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. The lots covered by this recall include doses of 25, 50, 75, and 100 mcg/hr and are listed in the firm's press release.

[August 08, 2008 - Press Release - Watson]
[March 01, 2008 - Press Release - Actavis]
[February 17, 2008 - Press Release - Actavis]

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Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches
Audience: Pain management specialists, other healthcare professionals, patients
[Posted 02/15/2008] PriCara and Sandoz Inc. announced a nationwide recall of all lots of 25 mcg/hr Duragesic Patches sold in the United States. The product is being recalled because the patches may have a cut along one side of the drug reservoir within the patch which may result in the possible release of fentanyl gel that may expose patients or caregivers directly to fentanyl gel on the skin. Fentanyl is a potent Schedule II opioid medication and exposure to the gel may lead to serious adverse events, including respiratory depression and possible overdose, that may be fatal. Patches with a cut edge should not be used. These recalled patches have expiration dates on or before December 2009 and are all manufactured by ALZA Corporation.

[February 12, 2008 - Press Release - PriCara]

Previous MedWatch alert:

[December 21, 2007]

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Heparin Sodium Injection
Audience: Surgeons, dialysis center staff, hospital risk managers, and other healthcare professionals
[UPDATE 05/15/2008] Atrium Medical Corporation announced that it is initiating a voluntary and precautionary recall of selected lots of Hydraglide Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS).

[UPDATE 05/15/2008] Medtronic Inc., initiated a voluntary recall of selected products featuring the Carmeda BioActive surface. The recalled products are used during cardiopulmonary bypass heart surgeries. Limited lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). It is unclear if exposure to Carmeda-coated medical devices, made with small amount of heparin, could cause adverse events similar to those observed with injectable heparin formulations. Patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time.

Medtronic is also advising customers that selected lots of Trillium-coated products were also manufactured with heparin containing OSCS. The amount of heparin on the product is significantly lower than that contained on the Carmeda product. Based on current data, the benefit of using the affected products outweighs any potential risk to patients. The maximum possible patient exposure to heparin from Trillium is extremely low; therefore, customers can continue to use the affected Trillium products until a replacement is available.

[UPDATE 05/09/2008] FDA requested that health professionals and facilities review and examine all drug/device storage areas, including emergency kits, dialysis units and automated drug storage cabinets to ensure that all recalled heparin products have been removed and are no longer available for patient use. In addition, FDA informed health professionals about other types of medical devices that contain, or are coated with, heparin.

[UPDATE 04/29/2008] Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products.

[UPDATE 02/28/2008] Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection, and their heparin lock flush solutions.

[Posted 02/11/2008] FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded. The reports have largely involved use of multiple-dose vials. However, there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. Heparin sodium is an anticoagulant (blood thinner) that is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis and pulmonary emboli. Heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses.

The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection.

[May 12, 2008 - Press Release - Atrium]
[May 07, 2008 - Press Release - Medtronic]
[April 25, 2008 - Information on Heparin Sodium Injection - FDA/CDER]
[April 25, 2008 - Update to Healthcare Facilities and Healthcare Professionals - FDA/CDRH]
[March 07, 2008 - Updated Questions and Answers - FDA]
[February 28, 2008 - Public Health Update - FDA]
[February 28, 2008 - Press Release - Baxter]
[February 11, 2008 - Public Health Advisory - FDA] UPDATED 02/28/2008
[February 11, 2008 - Questions and Answers - FDA]
[February 11, 2008 - News Release - FDA]

Previous MedWatch alert:

[January 18, 2008]

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Chattem Icy Hot Heat Therapy Products
Audience: Consumers, healthcare professionals
[UPDATED 03/11/2008] FDA issued a Class II Recall of all Icy Hot Heat Therapy products.

[Posted 02/11/2008] Chattem, Inc. and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of its Icy Hot Heat Therapy products, including consumer "samples" that were included on a limited promotional basis in cartons of its 3 oz Aspercreme product. The products were recalled because of consumer reports of first, second and third degree burns as well as skin irritation. All lots and sizes of the following Icy Hot Heat Therapy products were recalled:

Icy Hot Heat Therapy Air Activated Heat - Back
Icy Hot Heat Therapy Air Activated Heat - Arm, Neck, and Leg
Icy Hot Heat Therapy Air Activated Heal - Arm, Neck, and Leg single consumer use "samples" on a limited promotional basis in cartons of 3 oz. Aspercreme Pain Relieving Cream.

Consumers who have the Icy Hot Heat Therapy products under this recall should immediately stop using the products, discard them, and /or return them to the manufacturer.

[March 10, 2008 - Recall Notice - FDA]
[February 25, 2008 - Consumer Questions and Answers - FDA]
[February 08, 2008 - Press Release - Chattem, Inc.]

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Botox, Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B)
Audience: Cosmetic Surgeons, neurologists, other healthcare professionals, consumers
[Posted 02/07/2008] FDA issued an early communication about an ongoing safety review regarding Botox and Botox Cosmetic. FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. See the FDA's "Early Communication about an Ongoing Safety Review" for Agency recommendations and additional information for healthcare professionals.

[February 08, 2008 - Early Communication about an Ongoing Safety Review - FDA]

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Injectable Colchicine (including drugs containing colchicine)
Audience: Healthcare professionals
[Posted 02/06/2008] FDA announced its intention to take enforcement action against companies marketing unapproved, injectable colchicine, a drug used to treat gout. Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death. The FDA is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure. This action does not affect colchicine products that are dispensed in tablet form.

Individuals and companies must stop making these products within 30 days and stop shipping the product within 180 days or face regulatory action. After these dates, all injectable colchicine drug products must have FDA approval to be manufactured or shipped interstate.

[February 06, 2008 - News Release - FDA]
[February 06, 2008 - Questions and Answers - FDA]

Previous MedWatch alert:

[05/02/2007]

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Medtronic SynchroMed EL Implantable Infusion Pump
Audience: Pain management specialists, risk managers, other healthcare professionals, patients
[Posted 02/04/2008] FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories. The models were recalled because there is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors manufactured before September 1999. If a pump motor stalls, drug delivery will stop suddenly and without warning. This stoppage will result in loss of therapy, return of the patient's symptoms, and/or symptoms of drug under infusion or withdrawal. Healthcare professionals and patients with questions should contact the manufacturer.

[February 04, 2008 - Recall Notice - FDA]

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Varenicline (marketed as Chantix)
Audience: Neuropsychiatric and other healthcare professionals, consumers
[Posted 02/01/2008] FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy. See the FDA Information for Healthcare Professionals Sheet for recommendations and considerations for healthcare professionals on using Chantix therapy for patients.

[February 01, 2008 - Public Health Advisory - FDA]
[February 01, 2008 - Prescribing Information - Pfizer] Adobe Acrobat pdf format
[February 01, 2008 - Healthcare Professional Information Sheet - FDA]

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Antiepileptic Drugs
Audience: Neuropsychiatric healthcare professionals, other healthcare professionals, patients
[UPDATE 12/16/2008] The FDA has completed its analysis of reports of suicidality (suicidal behavior or ideation [thoughts]) from placebo-controlled clinical trials of drugs used to treat epilepsy, psychiatric disorders, and other conditions. Based on the outcome of this review, FDA is requiring that all manufacturers of drugs in this class include a Warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions.

[Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.

Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The drugs included in the analyses include (some of these drugs are also available in generic form):

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)

Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.

[December 16, 2008 - Drug Information Page - FDA]
[January 31, 2008 - Healthcare Professional Information Sheet - FDA]

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NuCel Labs Eye Drops and Eye/Ear Wash Products
Audience: Consumers, ophthalmologists, optometrists, other healthcare professionals
[Posted 01/31/2008] NuCel Labs and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of all Eye Drops and Eye/Ear Wash Products. The products were recalled after testing indicated the presence of bacteria and particulate matter, deeming these products non-sterile. Non-sterile eye drops pose an unacceptable risk of causing eye infections, which in rare cases could lead to blindness. No illnesses or injuries have been reported to date. There are no lot numbers or expiration dates on the products. Consumers who have the product should discontinue use of the product and return it to NuCel Labs. See the manufacturer's press release for return shipping information.

[January 31, 2008 - Press Release - NuCel Labs]

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Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor): Early Communication about an Ongoing Data Review
Audience: Cardiovascular healthcare professionals and patients
[UPDATE 01/08/2009] The FDA has completed its review of the final clinical study report of ENHANCE and issued an update.

[Posted 01/25/2008] FDA provided healthcare professionals with an early communication about an ongoing data review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor). This early communication is in keeping with FDA’s commitment to inform the public about ongoing postmarketing drug issues.

Merck/Schering Plough Pharmaceuticals reported preliminary results from the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial. This trial was designed to evaluate the amount of atherosclerotic plaque in blood vessels located in the neck based on images obtained through ultrasound in patients treated with Vytorin (ezetimibe plus simvastatin) or simvastatin alone.  Merck/Schering Plough stated that there was no significant difference between Vytorin and simvastatin in the amount of atherosclerotic plaque in the inner walls of the carotid (neck) arteries despite greater lowering of LDL-cholesterol (bad cholesterol) with Vytorin compared to simvastatin. Once Merck/Schering Plough completes the analysis of the unblinded data from ENHANCE, it will submit a final study report to FDA. Once FDA receives the final study report, FDA estimates it will take approximately 6 months to fully evaluate the data. After reviewing the data from the ENHANCE study, and considering all other available information about the link between LDL lowering and reduction of cardiovascular events, FDA will determine whether any further regulatory action is warranted with regard to Zetia and Vytorin and also whether any changes to FDA’s current approach to drugs that lower LDL cholesterol are warranted.

Patients should talk to their doctors if they have any questions about the information from the ENHANCE trial.

[January 08, 2009 - Update of Safety Review - FDA]
[July 18, 2008 - Making Sense of Vytorin Concerns - Consumer Q & A - FDA]
[January 25, 2008 - Early Communication about an Ongoing Data Review - FDA]

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Cordis Corporation Dura Star RX and Fire Star RX PTCA Balloon Catheters
Audience: Cardiovascular healthcare professionals, hospital risk managers
[Posted 01/25/2008] Cordis Corporation and FDA informed healthcare professionals of a Class I recall of All Fire Star and Dura Star balloon catheters, lots 13173912 through 13315455, plus 52 additional lots above 13315455. Balloon catheters are used in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels or arteries of the heart. The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure, or death.

[January 25, 2008 - Recall Notice - FDA]

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Leukine (sargramostim)
Audience: Oncologists, hematologists, other healthcare professionals
[Posted 01/24/2008] Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine. Healthcare professionals should immediately stop using liquid Leukine and return unused vials to the manufacturer.

[January 23, 2008 - Dear Healthcare Professional Letter - Bayer Healthcare] Adobe Acrobat pdf format

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Ortho Evra Contraceptive Transdermal Patch
Audience: Reproductive healthcare professionals, patients
[Posted 01/19/2008] FDA modified the prescribing information for the Ortho Evra Contraceptive Transdermal (Skin) Patch to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism. The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These findings support an earlier study that also said women in this group were at higher risk for VTE.

FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options.

[January 18, 2008 - News Release - FDA]
[January 18, 2008 - Questions and Answers - FDA]

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Heparin Sodium Injection 1000 units/mL 1OmL and 30 mL Vials
Audience: Pharmacists, hospital risk managers, other healthcare professionals
[Posted 01/18/2008; updated 01/29/2008] Baxter Healthcare and FDA notified healthcare professionals of a voluntary recall of certain lots of Heparin as a precaution due to an increase in reports of adverse patient reactions associated with these lots. Baxter is in the process of an in-depth investigation to determine the root cause of the reported reactions.

Reported adverse events include abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, increased lacrimation, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli. There have been no reports involving fatality. See the recall notice for a list of affected lots.

[January 25, 2008 - Press Release - Baxter Healthare]
[January 17, 2008 - Recall Notice - Baxter Healthcare]

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Heparin and Normal Saline Pre-Filled Flushes
Audience: Pharmacists, hospital risk managers, other healthcare professionals, patients
[Posted 01/18/2008; updated 01/30/2008] AM2 PAT, Inc., notified healthcare professionals and patients of a nationwide recall of all lots of both Heparin and Normal Saline pre-filled flushes. These products are distributed under two brand names, Sierra Pre-Filled Inc and B. Braun. The products are sold in 3ml and 5ml sizes for Heparin and 3ml, 5ml, and 10ml sizes for Normal Saline. One lot of Heparin IV flush syringes (1003-02, Lot 070926H) was contaminated with Serratia marcescens which has resulted in patient infections. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

User facilities and consumers should stop using the product immediately, quarantine remaining inventory, and return the product to their respective distributor. For a complete list of the recalled products, see the Recall Notice.

[January 30, 2008 - Class 1 Recall - FDA]
[January 25, 2008 - News Release - FDA]
[January 18, 2008 - Press Release - AM2 PAT, Inc.]
[January 18, 2008 - Press Release - B. Braun]

Previous MedWatch alert:

[December 21, 2007]

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Cough and Cold Medications in Children Less Than Two Years of Age
Audience: Consumers, pediatric and primary care healthcare professionals
[Posted 01/17/2008] FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur. FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. See the FDA Public Health Advisory for Agency recommendations regarding this issue.

[January 17, 2008 - Public Health Advisory - FDA]

Previous MedWatch alert:
[Jan 12, 2007]

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Edetate Disodium (marketed as Endrate and generic products)
Audience: Hospital Risk Managers, pharmacists, other healthcare professionals, patients
[Posted 01/16/2008] FDA notified healthcare professionals and patients about important safety information concerning Edetate Disodium. There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA. Edetate Disodium was approved as an emergency treatment for certain patients with hypercalcemia (very high levels of calcium in the blood) or certain patients with heart rhythm problems as a result of very high amounts of digitalis in the blood. Edetate Calcium Disodium was approved to reduce dangerously high blood lead levels (severe lead poisoning).

The two drugs have very similar names and are commonly referred to only as EDTA. As a result, the two products are easily mistaken for each other when prescribing, dispensing, and administering them. Edetate Disodium and Edetate Calcium Disodium works by binding with heavy metals or minerals in the body allowing them to be passed out of the body through the urine. Read the FDA Public Health Advisory for recommended and important safety considerations for healthcare professionals until the FDA's ongoing evaluation of the risks and benefits of Edetate Disodium is complete.

[January 16, 2008 - Public Health Advisory - FDA]
[January 16, 2008 - Questions and Answers - FDA]

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Unretrieved Device Fragments
Audience: Radiologists, surgeons, hospital risk managers, other healthcare professionals
[Posted 01/15/2008] FDA advised healthcare professionals of serious adverse events associated with unretrieved device fragments (UDFs). A UDF is a fragment of a medical device that has separated unintentionally and remains in the patient after a procedure. Patients may not be aware that this has occurred. The FDA Center for Devices and Radiological Health receives nearly 1000 adverse event reports each year related to UDFs. The adverse events reported included local tissue reaction, infection, perforation and obstruction of blood vessels, and death. Contributing factors may include biocompatibility of the device materials, location of the fragment, potential migration of the fragment, and patient anatomy. During MRI procedures, magnetic fields may cause metallic fragments to migrate, and radiofrequency fields may cause them to heat, causing internal tissue damage and/or burns. See the FDA Public Health Notification for the Agency's recommendations regarding this issue.

[January 15, 2008 - Public Health Notification - FDA]

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Compounded Menopause Hormone Therapy Drugs
Audience: Healthcare Professionals, patients
[Posted 01/10/2008] FDA informed healthcare professionals and patients that the Agency sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency. The pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and has not been proven safe and effective for any use) are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer's disease, stroke, and various forms of cancer. FDA is concerned that the claims for safety, effectiveness, and superiority that these pharmacy operations are making mislead patients, as well as doctors and other healthcare professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness.

Patients who use compounded hormone therapy drugs should discuss menopausal hormone therapy options with their healthcare provider to determine if compounded drugs are the best option for their specific medical needs.

[January 09, 2008 - News Release - FDA]

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Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa)
Audience: Orthopedic Surgeons, other healthcare providers, patients
[Posted 01/07/2008] FDA informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics. The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonates. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.

Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.

[January 07, 2008 - Drug Information page - FDA]

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