How to Find a Safety Summary

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   Biologics - Special Nutritional Products and Cosmetics - Drugs and Therapeutic Biologics - Medical Devices
   
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Biologics (CBER):

Human tissue recovered by Biomedical Tissue Services, Ltd. (BTS) (Posted 03/02/2006)
Human Tissues recovered by Donor Referral Services (DRS) (Posted 08/31/2006)
Menactra (Meningococcal Conjugate Vaccine A, C, Y, and W135) (Posted 10/23/2006)
WinRho SDF (Rho(D) Immune Globulin Intravenous [Human]) (Posted 01/06/2006)

Special Nutritional Products and Cosmetics:

Advanced Arthritis Support Capsules (Posted 09/07/2006)
Anabolic Xtreme Superdrol (Posted 03/10/2006)
Brazilian Diet Pills (Emagrece Sim and Herbathin products) (Posted 01/13/2006)
Coral Max Capsules, Coral Max without Iron Capsules (Posted 09/07/2006)
Dietary Supplements Containing Ephedrine Alkaloids (Posted 08/22/2006)
Dietary Supplements Promoted for Sexual Enhancement (Posted 07/13/2006)
Ellagimax Capsules (Posted 09/07/2006)
Mead Johnson GENTLEASE powdered infant formula (Posted 02/22/2006)
Methyl-1-P (Posted 03/10/2006)

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Drugs and Therapeutic Biological Products (CDER):

5-Hydroxytryptamine Receptor Agonists (Triptans) - Serotonin Syndrome (Posted 07/19/2006)
Accutane and generic isotretinoin (Posted 10/06/2006)
Acetaminophen 500 mg Caplets by Perrigo Company (Posted 11/09/2006)
Anabolic Xtreme Superdrol (Posted 03/10/2006)
Angiotensin-converting enzyme inhibitor (ACE inhibitors) drug class (Posted 06/07/2006)
Aptivus (tipranavir) (Posted 06/30/2006)
Avandamet (rosiglitazone maleate) (Posted 01/05/2006)
Avandia (rosiglitazone maleate/metformin hcl) (Posted 01/05/2006)
Avastin (bevacizumab) (Posted 09/25/2006)
Azathioprine Tablets, 50 mg (Posted 07/13/2006)
Benzocaine sprays (Posted 02/13/2006)
Bismacine/Chromacine (Posted 07/21/2006)
Cefazolin for Injection (Posted 03/01/2006)
Clozaril (clozapine) (Posted 01/13/2006)
Complete MoisturePLUS Contact Lens Care Products (Posted 11/22/2006)
Compounded topical anesthetic creams (Posted 12/06/2006)
Coumadin (warfarin sodium) (Posted 10/06/2006)
Cytosol Laboratories, Inc. Balanced Salt Solution (Posted 02/14/2006)
Dexedrine (dextroamphetamine sulfate) (Posted 08/21/2006)
Diastat AcuDial (diazepam rectal gel) (Posted 03/30/2006)
Dolophine (methadone hydrochloride) (Posted 11/27/2006)
Droxia (hydroxyurea capsules) (Posted 01/26/2006)
Effexor (venlafaxine HCl), Effexor XR (venlafaxine HCl) Extended-Release Capsules (posted 10/25/2006)
Elidel Cream (pimecrlimus) (posted 01/20/2006)
Fleet Phospho-Soda and Fleet Accu-Prep (Posted 05/05/2006)
Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (Posted 06/07/2006; UPDATED 12/22/2006)
Gleevec (imatinib mesylate) (Posted 10/19/2006)
Goldline Brand Extra Strength Genapap and Extra Strength Genebs (Posted 05/02/2006)
Heartland Repack Services products (Posted 10/25/2006)
Heparin Sodium Injection (Posted 12/08/2006)
High-Strength Hydrogen Peroxide (Posted 07/27/2006)
Hydralazine HCl Injection, USP, 20 mg/mL (Posted 08/04/2006; UPDATED 08/25/2006)
Hydrea (hydroxyurea capsules) (Posted 01/26/2006)
Ibuprofen and Aspirin Taken Together (Posted 09/08/2006)
Isotretinoin - Accutane and generic isotretinoin (Posted 10/06/2006)
Illegal Steroid Products Sold as Dietary Supplements (Posted 03/10/2006)
Ketek (telithromycin) (Posted 06/29/2006)
Ketek (telithromycin) (Posted 01/20/2006)
Lamictal (lamotrigine) (Posted 09/29/2006)
Macugen (pegaptanib sodium injection) (Posted 04/07/2006)
Methadone Hydrochloride (dolophine) (Posted 11/27/2006)
Methyl-1-P (Posted 03/10/2006)
Mifeprex (mifepristone) (Posted 03/17/2006)
NeutraGard 0.05% and NeutraGard Plus 0.2% Neutral Sodium Fluoride Anticavity Treatment Rinse (Posted 04/28/2006)
Nimotop (nimodipine) (Posted 02/15/2006)
Ontak (denileukin diftitox) (Posted 03/15/2006)
Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (Posted 05/05/2006)
Ortho Evra (norelgestromin/ethinyl estradiol) (Posted 09/20/2006)
Osmoprep Tablets (Posted 05/05/2006)
Paxil (paroxetine hydrochloride) (Posted 05/12/2006)
Promethazine HCl (marketed as Phenergan and generic products)  (Posted 4/25/2006)
Protopic Ointment (tacrolimus) (Posted 01/20/2006)
Quinine products (Posted 12/12/2006)
Rituxan (Rituximab) (Posted 12/18/2006)
Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs) - Serotonin Syndrome (Posted 07/19/2006)
SSRIs and Treatment Challenges of Depression in Pregnancy (Posted 07/19/2006)
Selective Serotonin Reuptake Inhibitors (SSRIs) - Serotonin Syndrome (Posted 07/19/2006)
Tacrolimus Active Pharmaceutical Ingredient [API] (Posted 05/18/2006)
Tamiflu (oseltamivir phosphate) (Posted 11/13/2006)
Tequin (gatifloxacin) (Posted 02/16/2006)
Tracleer (bosentan) (Posted 03/02/2006)
Trasylol (aprotinin) (Posted 02/08/2006; UPDATED 09/29/2006, 12/15/2006)
Triaminic Vapor Patch (Posted 06/20/2006)
Tysabri (natalizumab) (Posted 06/05/2006; UPDATED 07/21/2006)
Ultravist (iopromide) Injection 370mgl/mL, 125 mL (Posted 07/21/2006; UPDATED 07/31/2006)
Unapproved Compounded Inhalation Drugs (Posted 08/10/2006)
Visicol Tablets (Posted 05/05/2006)
WellPatch Cough & Cold Soothing Vapor Pads (Posted 07/19/2006)

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Medical Devices:

Alaris SE Infusion Pumps (Posted 08/29/2006; UPDATED 09/26/2006)
At-Home Genetic Tests (Posted 07/31/2006)
Baxter Healthcare Corp. COLLEAGUE Volumetric Infusion Pumps and Syndeo Patient Controlled Analgesic Syringe Pump (Posted 07/07/2006)
Baxter Healthcare Corp. COLLEAGUE and COLLEAGUE CX Volumetric Infusion Pumps (Posted 04/28/2006)
Baxter Healthcare Corp. COLLEAGUE and COLLEAGUE CX Volumetric Infusion Pumps (Posted 02/02/2006)
Blackstone Medical ICON Modular Fixation System (Posted 4/17/2006)
Boca Medical Ultilet and Closercare Insulin Syringes (Posted 05/23/2006)
Boca Medical Ultilet Insulin Syringe 30g 1/2cc (Posted 4/17/2006)
Boston Scientific Flextome Cutting Balloon Systems (Posted 02/02/2006)
Boston Scientific Mach 1 Guide Catheters (Posted 12/22/2006)
Cochlear Implants with a Positioner (Posted 02/02/2006)
Davol/Bard Composix Kugel Mesh Patch (Posted 03/02/2006; UPDATED 03/31/2006)
Disetronic D-TRONplus Power Packs used in D-TRONplus Insulin Pumps (Posted 07/14/2006; UPDATED 09/19/2006)
Disetronic Medical Systems ACCU-CHEK Ultraflex Infusion Sets (Posted 04/04/2006; UPDATED 07/24/2006)
Fungal Keratitis Infections Related to Contact Lens Use (Posted 04/11/2006; UPDATED 4/17/2006; UPDATED 05/05/2006; UPDATED 05/15/2006)
Gambro Prisma Continuous Renal Replacement System (UPDATE to August 2005 alert, posted 03/01/2006)
Guidant CONTAK RENEWAL TR/TR2 Cardiac Resynchronization Therapy Pacemakers (Posted 06/26/2006; UPDATED 04/12/2007)
Guidant INSIGNIA and NEXUS Pacemakers (Posted 06/26/2006; UPDATED 07/11/2006, 04/12/2007)
Guidant VENTAK PRIZM 2, VITALITY and VITALITY 2 Implantable Cardioverter Defibrillators (Posted 06/26/2006, UPDATED 04/12/2007)
Hamilton Medical, Inc. RAPHAEL Ventilators (Posted 06/12/2006)
Hospital Bed Entrapments (Posted 03/09/2006)
LifeScan One Touch Blood Glucose Test Strips -- Counterfeit Alert (Posted 10/13/2006; UPDATED 10/24/2006, 12/12/2006, 02/06/2007, 03/12/2007)
Medtronic Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit (Posted 07/21/2006; UPDATED 09/08/2006)
Ortho VITROS Immunodiagnostic HBsAg Confirmatory Kit (Posted 01/09/2006)
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Signal Reagent (Posted 4/18/2006)
Ossur Total Knee prosthetic device (Posted 03/31/2006)
Oxygen Regulator Fires Resulting from Incorrect Use of CGA 870 Seals (Posted 04/25/2006; UPDATED 06/20/2006)
Reprocessing of Reusable Ultrasound Transducer Assemblies Used for Biopsy Procedures (Posted 06/20/2006)
Respironics PLV Continuum Ventilator (PLVC I) (Posted 05/05/2006)
Roche Diagnostics ACCU-CHEK Aviva Meters (Posted 01/19/2006)
Roche Diagnostics CoaguChek PT Test Strips (Posted 10/20/2006)
Sage Products Inc. Comfort Shield Perineal Care Washcloths (Posted 06/26/2006)
Steris Amsco Sonic Energy Cleaner and Amsco Sonic Energy Console (Posted 08/31/2006)
The First Years Liquid-Filled Teethers (Posted 01/30/2006; UPDATED 02/10/2006)
Ultravist (iopromide) Injection 370mgl/mL, 125 mL (Posted 07/21/2006)
Vapotherm 2000i and 2000h Respiratory Gas Humidifier (Posted 01/30/2006)
Welch Allyn AED20 Automatic External Defibrillators (Posted 06/12/2006)
Welch Allyn PIC 50 Automated External Defibrillators (Posted 07/07/2006)

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= Adobe Acrobat file (.pdf file), viewed with free Acrobat Reader software. For more information, go to the MedWatch "downloads" page at http://www.fda.gov/MedWatch/getforms.htm

Boston Scientific Mach 1 Guide Catheters

Audience: Hospital risk managers, cardiovascular healthcare professionals
[Posted 12/22/2006] Boston Scientific Corporation and FDA informed healthcare professionals of a recall of 12 lots of Mach 1 Guide Catheters, used to deliver medical devices to the heart to treat coronary artery diesease. The affected product was distributed to hospitals in the United States. Some product units of the affected lots may contain excess strands of resin in the inner lumen near the hub of the guide catheter. If excess resin is present in the catheter and detaches during a procedure, there is the potential for embolization. If an obstruction occurs in a major blood vessel or multiple small blood vessels, it may result in serious complications such as stroke, heart attack or kidney problems.

[December 15, 2006 - Press Release - Boston Scientific]

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Rituxan (Rituximab)

Audience: Oncologists, Rheumatologists, other healthcare professionals, and consumers
Indication: Treatment of CD20-postive, B-cell, non-Hodgkins lymphoma and for moderately-to-severely-active rheumatoid arthritis when there has been inadequate response to other treatments.
[Posted 12/18/2006] FDA and Genentech informed healthcare professionals of important emerging safety information about Rituxan. Two patients died after being treated with Rituxan for systemic lupus erythematosus (SLE). Rituxan is approved for the above indication and is prescribed off-label for other serious diseases and conditions such as SLE. The cause of death was a viral infection of the brain called progressive multifocal leukoencephalopathy (PML) that is caused by reactivated JC virus which is present in about 80 percent of adults. Physicians should maintain a high index of suspicion for the development of PML in patients under treatment with Rituxan.

[December 18, 2006 - Healthcare Professional Sheet - FDA]
[December 18, 2006 - Public Health Advisory - FDA]
[December 18, 2006 - Drug Information Page - FDA]

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Quinine products

Audience: Pharmacists, other healthcare professionals and consumers
[Posted 12/12/2006] FDA informed healthcare professionals and consumers that the Agency ordered firms to stop marketing unapproved drug products containing quinine, citing serious safety concerns, including deaths associated with quinine products. There are multiple unapproved products containing quinine currently on the market, used off-label to treat leg cramps and similar conditions. Since 1969, FDA received 665 reports of adverse events with serious outcomes associated with quinine use, including 93 deaths. Quinine drugs are associated with serious side effects, such as cardiac arrhythmias, thrombocytopenia, and severe hypersensitivity reactions. Qualaquin, manufactured by Mutual Pharmaceutical Company, is the only quinine product approved by the FDA.

[December 12, 2006 - Press Release - FDA]

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Heparin Sodium Injection

Audience: Vascular surgeons, ER personnel, pharmacists, and other healthcare professionals
[Posted 12/08/2006] FDA notified healthcare professionals of revisions to the WARNINGS section of the prescribing information for Heparin to inform clinicians of the possibility of delayed onset of heparin-induced thrombocytopenia (HIT), a serious antibody-mediated reaction resulting from irreversible aggregation of platelets. HIT may progress to the development of venous and arterial thromboses, a condition referred to as heparin-induced thrombocytopenia and thrombosis (HITT). Thrombotic events may be the initial presentation for HITT which can occur up to several weeks after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT.

[October 2006 - Label - Baxter]

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Compounded topical anesthetic creams

Audience: Consumers, Pharmacists and other healthcare professionals
[Posted 12/06/2006] FDA notified healthcare professionals and consumers about the serious public health risks related to compounded topical anesthetic creams. FDA issued warning letters to five firms to stop compounding and distributing standardized versions of topical anesthetic creams, marketed for general distribution. Exposure to high concentrations of local anesthetics, like those in compounded topical anesthetic creams, can cause grave reactions including seizures, irregular heartbeats and death. Compounded topical anesthetic creams are often used to lessen pain in procedures such as laser hair removal, tattoos, and skin treatments. They may be dispensed by clinics and spas that provide these procedures, or by pharmacies and doctors’ offices.

[December 05, 2006 - News Release - FDA]

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Dolophine (methadone hydrochloride)

Audience: Pain management specialists, pharmacists, and other healthcare professionals
Indication: Treatment of moderate to severe pain not responsive to non-narcotic analgesics; detoxification of opioid addiction; and maintenance treatment of opioid addiction
[Posted 11/27/2006] FDA notified healthcare professionals of reports of death and life-threatening adverse events such as respiratory depression and cardiac arrhythmias in patients receiving methadone. These adverse events are the possible result of unintentional methadone overdoses, drug interactions, and methadone's cardiac toxicities (QT prolongation and Torsades de Pointes). The reports underscore the importance of knowing methadone's toxicities and unique pharmacologic properties, including dosing and monitoring recommendations.

[November 27, 2006 - Public Health Advisory - FDA]
[November 27, 2006 - Patient Package Insert - Roxane]
[November 27, 2006 - Healthcare Professional Sheet - FDA]
[November 27, 2006 - Prescribing Information - Roxane]

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Complete MoisturePLUS Contact Lens Care Products

Audience: Ophthalmologists, optometrists, other healthcare professionals and consumers
Indication: Contact lens care
[Posted 11/22/2006] FDA and Advanced Medical Optics, Inc. informed healthcare professionals and consumers of a nationwide recall of 18 lots of Complete MoisturePLUS multipurpose contact lens care solution and Active Packs distributed in the United States. Certain lots were found to have bacterial contamination which compromised sterility. Non-sterility of a contact lens solution may have serious health consequences, including eye infection and microbial keratitis.

Contact lens users who have the recalled product should discontinue use immediately and individuals who experience symptoms of an eye infection such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling, should remove their lenses and consult their eye care provider immediately.

[November 21, 2006 - Press Release - Advanced Medical Optics, Inc.]

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Erythropoiesis Stimulating Agents
Procrit, Epogen, and Aranesp

Audience: Oncologists, nephrologists, and other healthcare professionals
Indication: Treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis.
[Posted 11/17/2006] FDA notified healthcare professionals of a newly published clinical study showing that patients treated with an erythropoiesis-stimulating agent (ESA) and dosed to a target hemoglobin concentration of 13.5 g/dL are at a significantly increased risk for serious and life threatening cardiovascular complications, as compared to use of the ESA to target a hemoglobin concentration of 11.3 g/dL. The “Correction of Hemoglobin and Outcomes in Renal Insufficiency” study, published November 16, 2006 in the New England Journal of Medicine, reports the adverse cardiovascular complications as a composite of the occurrence of one of the following events: death, myocardial infarction, hospitalization for congestive heart failure, or stroke.

The study findings underscore the importance of following the currently approved prescribing information for Procrit, Epogen, and Aranesp, including the dosing recommendation that the target hemoglobin not exceed 12 g/dL.

[November 16, 2006 - Information for Healthcare Professionals - FDA] PDF
[November 16, 2006 - Public Health Advisory - FDA]

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Tamiflu (oseltamivir phosphate)

Audience: Pediatric and primary care healthcare professionals and patients
[Posted 11/13/2006] Roche and FDA notified healthcare professionals of revisions to the PRECAUTIONS/Neuropsychiatric Events and Patient Information sections of the prescribing information for Tamiflu, indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days and for the prophylaxis of influenza in patients 1 year and older.There have been postmarketing reports (mostly from Japan) of self-injury and delirium with the use of Tamiflu in patients with influenza. People with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior. A healthcare professional should be contacted immediately if the patient taking Tamiflu shows any signs of unusual behavior.

[November 13, 2006 - Letter - Roche]
[November 13, 2006 - Prescribing Information - Roche]
[November 13, 2006 - Patient Package Insert - Roche]

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Acetaminophen 500 mg Caplets by Perrigo Company

Audience: Healthcare professionals and consumers
[Posted 11/09/2006] FDA and Perrigo Company notified the public of a voluntary recall of 383 lots of acetaminophen 500 mg caplets manufactured and distributed under various store-brands as a result of small metal fragments found in a small number of these caplets. Consumers can determine if they are in possession of a recalled product by locating the batch number printed on the container label. A list of stores that carry store-brands potentially affected by this recall, as well as batch numbers affected, is located on FDA's website (referenced below).

To date, there have been no illness or injuries received related to this problem and no consumer complaints have been reported to the FDA or to Perrigo. Based on information currently available, the FDA believes the probability of serious adverse health consequences is remote; however, if a consumer were to swallow an affected caplet, it could result in minor stomach discomfort and/or possible cuts to the mouth or throat. Consumers should consult their physician if they suspect they've been harmed by use of this product.

[November 9, 2006 - News Release - FDA]
[November 9, 2006 - Perrigo Voluntary Product Recall Customer List - FDA]
[November 9, 2006 - Perrigo Recalled Batches - FDA]

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Heartland Repack Services products

Audience: Pharmacists and nursing home administrators
[Posted 10/25/2006] Heartland Repack Services and FDA notified healthcare professionals of a voluntary recall of all products containing a lot number beginning with “K” (example: K12345). Drugs repackaged by Heartland Repack Services are distributed through their own pharmacy services to Omnicare nursing homes and other institutional facilities. Omnicare is responsible for 1.4 million nursing home and healthcare patients in 47 states and Canada. These product lots are distributed in 30, 60, 90 count size boxes and 250 count bags. Both the boxes and bags contain unit dose strips of five tablets per strip. This recall was initiated because there is the potential for mislabeling and packaging mix-up.

Due to incomplete accounting of product subject to this recall, on October 20, 2006 Heartland Repack Services issued a follow-up notice of the July 2006 recall.

[July 27, 2006 - Recall Notice - Heartland Repack Services]
[July 27, 2006 - Recalled Product List - Heartland Repack Services] (1.7 MB pdf file, 119 pages)
[October 20, 2006 - Follow-up Questionnaire - Heartland Repack Services]

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Effexor XR (venlafaxine HCl) Extended-Release Capsules
Effexor (venlafaxine HCl) Tablets

Audience: Neuropsychiatric and other healthcare professionals
[Posted 10/25/2006] Wyeth and FDA notified healthcare professionals of revisions to the OVERDOSAGE/Human Experience section of the prescribing information for Effexor (venlafaxine HCl), indicated for treatment of major depressive disorder. In postmarketing experience, there have been reports of overdose with venlafaxine, occurring predominantly in combination with alcohol and/or other drugs. Published retrospective studies report that venlafaxine overdosage may be associated with an increased risk of fatal outcome compared to that observed with SSRI antidepressant products, but lower than that for tricyclic antidepressants. Healthcare professionals are advised to prescribe Effexor and Effexor XR in the smallest quantity of capsules consistent with good patient management to reduce the risk of overdose.

[October 17, 2006 - Letter - Wyeth]
[August, 2006 - Effexor Label - Wyeth]
[August, 2006 - Effexor XR Label - Wyeth]

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Menactra (Meningococcal Conjugate Vaccine A, C, Y, and W135)

Audience: Neurological and Pediatric healthcare professionals, and consumers
[Posted 10/23/2006] FDA and CDC updated an October 2005 alert to consumers and health care providers regarding reports of Guillain Barre Syndrome (GBS) following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135, manufactured by Sanofi Pasteur. To date a total of 15 confirmed cases of GBS among individuals 11-19 years of age occurring within six weeks of vaccination with Menactra have been reported to the Vaccine Adverse Event Reporting System (VAERS). Two additional cases have been confirmed in persons 20 years of age and older. All individuals are reported to be recovering or have recovered.

While the cases reported suggest a small increased risk of GBS following immunization with Menactra, the limitations in VAERS, and the uncertainty regarding background incidence rates for GBS require that these findings be viewed with caution. At this time, CDC and FDA cannot determine with certainty whether Menactra does increase the risk of GBS in persons who receive the vaccine and, if so, to what degree. At the present time, there are no changes in recommendations for vaccination and individuals should continue to follow their doctors' recommendations. FDA asks any persons with knowledge of possible cases of GBS occurring after receiving Menactra to report them to VAERS at http://www.vaers.hhs.gov or by phone at 1-800-822-7967.

[October 20, 2006 - Statement - FDA]
[October 20, 2006 - MMWR Update - CDC]

Previous MedWatch alert:

[October 03, 2005]

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Roche Diagnostics CoaguChek PT Test Strips

Audience: Consumers, Physicians and Hospital risk managers and laboratory managers
[Posted 10/20/2006] Roche Diagnostics and FDA informed consumers and healthcare professionals of the recall of CoaguChek PT test strips used to determine blood clotting time of patients taking anti-coagulant medication to prevent blood clots. The recall was due to the potential for a test strip defect that may cause falsely elevated test results. This may result in an incorrect dose of anti-coagulant medication or unnecessary corrective measures being taken to reduce the effect of circulating anti-coagulants. Healthcare professionals who use CoaguChek PT test strips should institute 'duplicate testing', or use two strips with different lot numbers, on each patient to reduce the risk of bias. Home users of CoaguChek PT test strip should immediately discontinue use of the product and contact their healthcare provider.

[October 20, 2006 - Press Release - Roche Diagnostics]

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Gleevec (imatinib mesylate)

Audience: Oncology and cardiology healthcare professionals
[Posted 10/19/2006] Novartis and FDA notified healthcare professionals about revisions to the PRECAUTIONS section of the prescribing information, describing the occasional occurrence of severe congestive heart failure and left ventricular dysfunction in patients taking Gleevec. Most of the patients with reported cardiac events had other co-morbidities and risk factors, including advanced age and previous medical history of cardiac disease. Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully and any patients with signs or symptoms consistent with cardiac failure should be evaluated and treated.

[October 19, 2006 - Letter - Norvartis] PDF
[September 2006 - Label - Novartis]

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LifeScan One Touch Blood Glucose Test Strips -- Counterfeit Alert

Audience: Pharmacists, other healthcare professionals and patients
[UPDATE 03/12/2007] Class I Recall expanded to include additional lot numbers of the One Touch Ultra (2691261) and Basic/Profile Blood Glucose Test Strips (2615211 and 227078A).

[UPDATE 02/06/2007] Matrix Distributors Inc. added as recalling firm.

[UPDATE 12/12/2006] Recall classified as Class I because use of the counterfeit products could cause serious injury or death. Recall includes One Touch Basic/Profile Blood Glucose Test Strips (Lot Numbers 272894A, 2619932, 2606340 50-count packages) and One Touch Ultra Blood Glucose Test Strips, LifeScan [lot Numbers 2691191, 50-count test strips (2 vials of 25 test strips)].

[UPDATE 10/24/2006] FDA provided two additional lot numbers that are included in the distribution of counterfeit products, along with descriptions of how to identify them.

[Posted 10/13/2006] LifeScan and FDA notified healthcare professionals and the public of counterfeit blood glucose test strips being sold in the United States for use with various models of the One Touch Brand Blood Glucose Monitors used by people with diabetes to measure their blood glucose. The counterfeit test strips potentially could give incorrect blood glucose values--either too high or too low--which might result in a patient taking either too much or too little insulin and lead to serious injury or death.

[December 12, 2006 - Recall Notice One Touch Ultra Blood Glucose Test Strips - FDA]
[December 12, 2006 - Recall Notice One Touch Basic/Profile Blood Glucose Test Strips - FDA]
[October 23, 2006 - News Release - FDA]
[October 13, 2006 - News Release - FDA]

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Coumadin (warfarin sodium)

Audience: Pharmacists, other healthcare professionals, and patients
[Posted 10/06/2006] FDA and Bristol-Myers Squibb notified pharmacists and physicians of revisions to the labeling for Coumadin, to include a new patient Medication Guide as well as a reorganization and highlighting of the current safety information to better inform providers and patients.

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. Information about all currently approved Medication Guides is available at http://www.fda.gov/cder/Offices/ODS/medication_guides.htm.

[October 2006 - Medication Guide - Bristol-Myers Squibb]
[October 2006 - Label - Bristol-Myers Squibb]

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Isotretinoin - Accutane and generic isotretinoin

Audience: Dermatological, other healthcare professionals and patients
[Posted 10/06/2006] FDA and the iPLEDGE program notified healthcare professionals and patients of an update to iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin, that will eliminate one element of the program, the 23 day lock-out period for males and females of non-child bearing potential. This change does not affect female patients of child-bearing potential.

[October 06, 2006 - Letter - iPLEDGE Program]
[October 06, 2006 - Drug Information Page - FDA]
[October 06, 2006 - Questions and Answers - FDA]

Previous MedWatch alert:

[August 12, 2005]


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Lamictal (lamotrigine)

Audience: Neurologists, obstetricians, other healthcare professionals, and patients
[Posted 09/29/2006] The FDA notified healthcare professionals and patients of new preliminary information from the North American Antiepileptic Drug Pregnancy Registry that suggests that babies exposed to Lamictal, indicated to treat seizures and bipolar disorder, during the first three months of pregnancy may have a higher chance of being born with a cleft lip or cleft palate. More research is needed to be sure about the possibility of the increased chance of cleft lip or cleft palate developing in babies of pregnant women who take Lamictal. Women who take Lamictal and are pregnant or are thinking of becoming pregnant should talk with their doctor. Patients should not start or stop using Lamictal without talking to their doctor.

[September 28, 2006 - Patient Information Sheet - FDA]
[September 28, 2006 - Healthcare Professional Sheet - FDA]

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Avastin (bevacizumab)

Audience: Oncological and neurological healthcare professionals
[Posted 09/25/2006] Genentech and FDA notified healthcare professionals about revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information to inform healthcare professionals of 1] cases of a rare brain-capillary leak syndrome [reversible posterior leukoencephalopathy syndrome (RPLS)] and 2] postmarketing reports of nasal septum perforation.

RPLS is a neurological disorder associated with hypertension, fluid retention and cytotoxic effects of immunosuppressive drugs on the vascular endothelium. The syndrome can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances. Mild to severe hypertension may be present, but is not necessary for diagnosis. The onset of symptoms has been reported to occur from 16 hours to 1 year after initiation of Avastin. Magnetic Resonance Imaging (MRI) is necessary to confirm the diagnosis of RPLS.

[September, 2006 - Updated Prescribing Information - Genentech]
[September, 2006 - Dear Healthcare Professional letter - Genentech]

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Ortho Evra (norelgestromin/ethinyl estradiol)

Audience: Gynecologists, other healthcare professionals and consumers
[Posted 09/20/2006] Ortho-McNeil and FDA notified healthcare professionals and patients about revisions to the prescribing information to inform them of the results of two separate epidemiology studies that evaluated the risk of developing a serious blood clot in women using Ortho Evra compared to women using a different oral contraceptive. The first study found that the risk of non-fatal venous thromboembolism (VTE) associated with the use of Ortho Evra contraceptive patch is similar to the risk associated with the use of oral contraceptive pills containing 35 micrograms of ethinyl estradiol and norgestimate.The second study found an approximate two-fold increase in the risk of medically verified VTE events in users of Ortho Evra compared to users of norgestimate-containing oral contraceptives containing 35 micrograms of estrogen. Although the results of the two studies differ, the results of the second study support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women.

Prescribing information for Ortho Evra continues to recommend that women with concerns or risk factors for thromboembolic disease talk with their healthcare professionals about using Ortho Evra versus other contraceptive options.

[September 20, 2006 - Updated Prescribing Information - Ortho-McNeil]
[September 20, 2006 - Q&A's - FDA]
[September 20, 2006 - Drug Information Page - FDA]

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Ibuprofen and Aspirin Taken Together

Audience: Consumers and healthcare professionals
[Posted 09/08/2006] FDA notified consumers and healthcare professionals that taking Ibuprofen for pain relief and aspirin at the same time may interfere with the benefits of aspirin taken for the heart. Ibuprofen can interfere with the anti-platelet effect of low dose aspirin (81 mg per day), that may render aspirin less effective when used for cardioprotection and stroke prevention. Although it is all right to use Ibuprofen and aspirin together, FDA recommends that consumers contact their healthcare professional for more information on the timing of when to take these two medicines, so that both medicines can be effective.

[September 8, 2006 - Healthcare Professional Sheet - FDA]
[September 8, 2006 - Science Paper - FDA]
[September 8, 2006 - Drug Information Page - FDA]

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Ellagimax Capsules, Coral Max Capsules, Coral Max without Iron Capsules, and Advanced Arthritis Support Capsules

Audience: Consumers and healthcare professionals
[Posted 09/07/2006] FDA notified healthcare professionals and consumers of the seizure of Ellagimax capsules, Coral Max capsules, Coral Max without Iron capsules, and Advanced Arthritis Support capsules distributed by Advantage Nutraceuticals, LLC, because the products, labeled as dietary supplements, are being promoted to treat serious disease conditions, including but not limited to cancer, arthritis, fibromyalgia, and seizures. The products have not been shown to be safe and effective to treat these conditions and have not been approved by the FDA and are therefore in violation of the new drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act.

FDA advised consumers who may be taking these products to consult their physicians.

[September 06, 2006 - News Release - FDA]

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Human Tissues recovered by Donor Referral Services (DRS)

Audience: Surgeons, dentists, hospital surgical service managers and risk managers
[Posted 08/31/2006] FDA notified healthcare professionals that human tissues recovered by Donor Referral Services (DRS) may not have met FDA requirements for donor eligibility. While no adverse reactions associated with these tissues have yet been reported, and subsequent processing should reduce the potential risks of infectious disease transmission, healthcare providers who were supplied with these tissues are being notified of the potentially increased risk for infectious disease transmission.

FDA and the Centers for Disease Control and Prevention (CDC) are strongly recommending that healthcare providers inform their patients who received tissues initially recovered by DRS that they may have received tissue from donors for whom adequate donor eligibility determinations were not performed, and offer patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2, hepatitis B virus, hepatitis C virus, and syphilis. Further recommendations for testing are posted on the CDC website at: http://www.cdc.gov/ncidod/dhqp/tissueTransplantsFAQ.html. FDA will continue its investigation into this matter and will issue further public health updates, as needed.

[August 30, 2006 - Public Health Notification - FDA]

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Steris Amsco Sonic Energy Cleaner and Amsco Sonic Energy Console

Audience: Hospital and long term care facility risk managers and materials managers
[Posted 08/31/2006] Steris and FDA notified hospital and long term care facility managers of a fire risk with use of Amsco Sonic Energy Cleaner and/or an Amsco Sonic Energy Console, used for cleaning reusable medical equipment. The affected products were manufactured from November 2000 until January 2005 bearing serial numbers 0432000018 to 0403105051. The location of the lid switch cable wiring harness in these units makes them susceptible to water damage to the electrical connections. If this occurs, it can cause overheating of the electrical system in the unit and lead to damage of the wiring harness(s) resulting in smoking, sparking, and fire.

Healthcare professionals are instructed to follow proper safety precautions to prevent water from contacting the electrical wiring while using this device. A Steris technician will visit account holders to replace the wire harness and associated components of the affected units.

[June 21, 2006 - Letter - Steris]

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Alaris SE Infusion Pumps

Audience: Healthcare administrators, risk managers, and healthcare professionals
[UPDATE 09/26/2006] Recall classified as Class I. The manufacturer provided recommendations to users for safe operation of the product. FDA provided Q&As.

[Posted 08/29/2006] FDA and Alaris Products notified healthcare professionals of a recall of defective infusion pumps due to a design defect called "key bounce" that may cause potential over-infusion of medications and result in an infusion rate at least 10 times the intended infusion rate. Infusion pumps are electronic devices intended for controlled delivery of intravenous solutions and medications to patients. Key bounce occurs when a number pressed once on the pump registers twice and not detected during programming verification. The products included in this recall (model numbers 7130,7131, 7230, and 7231) are distributed by Cardinal Health Care 303 Inc. The manufacturer provided recommendations to pump users on steps they can take to minimize key entry errors until the problem can be corrected. Healthcare facilities can continue to use pumps in their possession, guided by the company's instructions.

[September 26, 2006 - Recall Notice - FDA]
[September 26, 2006 - Questions and Answers - FDA]

[August 28, 2006 - Press Release - FDA]
[August 15, 2006 - Recall Letter - Alaris Products]

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Dietary Supplements Containing Ephedrine Alkaloids

Audience: Consumers and healthcare professionals
[Posted 08/22/2006] FDA informed consumers and healthcare professionals that all dietary supplements containing ephedrine alkaloids are illegal to market in the United States. Dietary supplements containing ephedrine alkaloids, regardless of the dosage, are considered adulterated and pose an unreasonable risk of illness or injury to users, especially those suffering from heart disease and high blood pressure. FDA conducted an exhaustive evaluation of relevant scientific data evidence on ephedrine alkaloids before issuing this decision in a final rule in 2004. On August 17, 2006, a Court of Appeals ruling upheld this final rule, reversing an earlier decision by the District Court of Utah.

[Aug 21, 2006 - Statement - FDA]
[Feb 06, 2004 - News Release - FDA]

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Dexedrine (dextroamphetamine sulfate)

Audience: Psychiatrists, pediatricians, mental healthcare professionals, pharmacists and consumers
[Posted 08/21/2006] The FDA and GlaxoSmithKline notified healthcare professionals of changes to the BOXED WARNING, WARNINGS and PRECAUTIONS sections of the prescribing information for Dexedrine (dextroamphetamine sulfate), approved for the treatment of Attention-Deficit Hyperactivity Disorder and narcolepsy. The warnings describe reports of sudden death in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems.

[August 04, 2006 - Letter - GlaxoSmithKline]
[June 2006 - Label - GlaxoSmithKline]

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Unapproved Compounded Inhalation Drugs

Audience: Pharmacists, other healthcare professionals, and consumers
[Posted 08/10/2006] The FDA notified consumers and healthcare professionals that RoTech Healthcare, Inc., CCS Medical, and Reliant Pharmacy Services are manufacturing and distributing unapproved compounded inhalation drugs nationwide. These drugs, compounded by pharmacists, are used to treat life-threatening conditions such as asthma, emphysema, bronchitis, and cystic fibrosis. Compounded inhalation drugs are not reviewed by the FDA for safety and effectiveness and are often not produced according to good drug manufacturing practice, which may expose patients to unnecessary risks. FDA urges consumers using inhalation drugs to discuss their medications with their physicians and verify with their pharmacists that the medications they received are what their physicians ordered. FDA encourages patients to use FDA-approved drugs whenever possible.

[August 10, 2006 - Press Release - FDA]

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Hydralazine HCl Injection, USP, 20 mg/mL

Audience: Cardiologists, pharmacists and other healthcare professionals
[Updated 8/25/2006] Luitpold Pharmaceuticals, Inc. and FDA notified healthcare professionals of a voluntary recall of additional lots of Hydralazine HCl Injection (20 mg/mL, 1 mL single dose vials) because the products may contain particulates.

[Posted 08/03/2006] Luitpold Pharmaceuticals, Inc. and FDA notified healthcare professionals of a voluntary recall because some vials of Hydralazine HCl Injection from lot number 5561 NO with an expiration date of December, 2006 (20 mg/mL, 1 mL single dose vials) may contain particulates. The lot is labeled with a NOVAPLUS label. Further use or distribution of this lot of product should cease.

[August 11, 2006 - Recall Letter - Luitpold Pharmaceuticals, Inc.]
[July 24, 2006 - Recall Letter - Luitpold Pharmaceuticals, Inc.]

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WellPatch Cough & Cold Soothing Vapor Pads

Audience: Consumers, Pharmacists and other healthcare professionals
[Posted 08/01/2006] The Mentholatum Company and FDA notified consumers and healthcare professionals about a nationwide recall of WellPatch Cough & Cold Soothing Vapor Pads due to potential serious adverse health effects that could result if the product is ingested by a child removing the patch and chewing on it. This product contains camphor, eucalyptus oil, and menthol. Possible adverse events associated with chewing or ingesting products containing camphor or eucalyptus oils can vary from minor symptoms, such as burning sensation in the mouth, headache, nausea and vomiting, to more severe reactions, such as seizures.

[August 01, 2006 – News Release –The Mentholatum Company]

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At-Home Genetic Tests

Audience: Consumers and genetics healthcare professionals
[Posted 07/31/2006] FDA, the Federal Trade Commission, and the Centers for Disease Control and Prevention alerted consumers about the facts surrounding the direct-to-consumers marketing of genetic tests.

According to the FDA, which regulates the manufacturers of genetic tests, and the CDC, which promotes health and quality of life, some of these tests lack scientific validity, and others provide medical results that are meaningful only in the context of a full medical evaluation. The FDA and CDC say that because of the complexities involved in both the testing and the interpretation of the results, genetic tests should be performed in a specialized laboratory, and the results should be interpreted by a doctor or trained counselor who understands the value of genetic testing for a particular situation.

[July 31, 2006 – News Release – FDA/CDRH/OIVD]

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High-Strength Hydrogen Peroxide

Audience: Consumers, pharmacists, and other healthcare professionals
[Posted 07/27/2006] FDA warned consumers not to purchase or to use high-strength hydrogen peroxide products, including a product marketed as "35 Percent Food Grade Hydrogen Peroxide," for medicinal purposes because they can cause serious harm or death when ingested. FDA recommends that consumers who are currently using high-strength hydrogen peroxide stop immediately and consult their health care provider.

FDA has never approved high-strength hydrogen peroxide to be taken internally and considers hydrogen peroxide at 35 percent strength dangerous, even if handled according to the manufacturer's directions. High-strength hydrogen peroxide -- more than 10 times stronger than the solution used in over-the-counter drugs to disinfect minor cuts -- is highly corrosive. Ingesting hydrogen peroxide can cause gastrointestinal irritation or ulceration. Intravenous (IV) administration of hydrogen peroxide can cause inflammation of the blood vessel at the injection site, gas embolisms (bubbles in blood vessels), and potentially life-threatening allergic reactions.

[July 27, 2006 – News Release – FDA]

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Medtronic Model 8731 Intrathecal Catheter
Medtronic Model 8598 Intrathecal Catheter Distal Revision Kit

Audience: Hospital operating room staff and other healthcare professionals, and hospital risk managers
[UPDATE 09/08/2006] Recall classified as Class I.

[Posted 07/21/2006] Medtronic and FDA notified healthcare providers of a voluntary recall of Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit. Medtronic is recalling these products because the platinum-iridium tip may be dislodged by the guide wire during implantation. Dislodgement of the tip can result in the risk of infection or other potentially serious adverse health consequences.

[July 2006 – Dear Healthcare Provider Letter – Medtronic]

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Ultravist (iopromide) Injection 370mgl/mL, 125 mL

Audience: Hospital Risk Managers, Imaging Center Administrators, other healthcare professionals
[UPDATED 07/31/2006] Berlex, Inc. and FDA announced a voluntary worldwide recall of all lots of Ultravist (iopromide) Injection 370mgl/mL, 125 ml, due to the presence of particulate matter and crystallization with the potential for thromboembolic safety problems if an affected product is administered to patients.

[Posted 07/21/2006] Berlex, Inc. and FDA announced a voluntary nationwide recall of a single lot (No. 41500A, Exp. 1/2007) of Ultravist (iopromide) Injection 370mgl/mL, 125 ml, an intravenous X-ray contrast agent, due to the presence of particulate matter in conjunction with crystallization. The product was recalled because of the potential for serious safety problems if Ultravist Injection is administered to patients. These problems may include thrombosis of blood vessels, thromboembolism and injury or infarction of end organs such as heart, kidney, and brain.

Hospitals, imaging centers and other healthcare facilities should not use any of the affected lot number (41500A) of Ultravist Injection 370mgL/mL, 125 mL for patient care and should immediately quarantine any product for return.

[July 31, 2006 - Press Release - Berlex]
[July 21, 2006 - Press Release - Berlex]

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Bismacine/Chromacine

Audience: All Healthcare professionals and consumers
[Posted 07/21/2006] FDA notified healthcare professionals and consumers not to use an injectable product called Bismacine, also known as Chromacine. Bismacine is not a pharmaceutical and has not been approved to treat any condition; however, it is being prescribed or administered by doctors of "alternative health" to treat Lyme disease.

This product contains high amounts of bismuth, a heavy metal that is used in some medications taken by mouth to treat Helicobacter pylori, a bacteria that can cause stomach ulcers. However, Bismacine is not approved in any form for use by injection. The FDA is investigating one report of a death and several reports of injury related to the administration of Bismacine. Individuals who believe they have suffered adverse events from receiving Bismacine should seek medical attention. Possible effects of bismuth poisoning include cardio-vascular collapse and kidney failure.

[July 21, 2006 - Press Release - FDA]

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SSRIs and Treatment Challenges of Depression in Pregnancy

Audience: Neuropsychiatric and other healthcare professionals, and consumers
[Posted 07/19/2006] FDA notified healthcare professionals and consumers of important information from two recent studies that should be considered when making treatment decisions in pregnant women who take antidepressants. The studies included pregnant women who were treated with selective serotonin reuptake inhibitors (SSRIs), or in a few cases, other antidepressant medications.

One study illustrated the potential risk of relapsed depression after stopping antidepressant medication during pregnancy. In this study, women who stopped their medicine were five times more likely to have a relapse of depression during their pregnancy than were women who continued to take their antidepressant medicine while pregnant.

The second study suggests there may be additional, though rare, risks of taking SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth. Babies born with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. In this study, PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk of one drug compared to another. The finding of PPHN in babies of mothers who used a SSRI antidepressant in the second half of pregnancy adds to concerns from previous reports that infants of mothers taking SSRIs late in pregnancy may experience difficulties such as irritability, difficulty feeding and in very rare cases, difficulty breathing.

Additionally, the labeling for paroxetine (Paxil) was recently changed to add information about findings in an epidemiologic study that suggests that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects.

Women who are pregnant or thinking about becoming pregnant should not stop any antidepressant medication without first consulting their physician. The FDA is seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy. FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN.

[July 19, 2006 - Public Health Advisory - FDA]

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5-Hydroxytryptamine Receptor Agonists (Triptans)
Selective Serotonin Reuptake Inhibitors (SSRIs)
Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs)
Serotonin Syndrome

Audience: Neuropsychiatric and other healthcare professionals, and consumers
[Posted 07/19/2006] FDA notified healthcare professionals and consumers of new safety information regarding taking medications used to treat migraine headaches (triptans) together with certain types of antidepressant and mood disorder medications (selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs). A life-threatening condition called serotonin syndrome may occur when triptans are used together with a SSRI or a SNRI.

Serotonin syndrome occurs when the body has too much of a chemical found in the nervous system (serotonin). Each of the above medications (triptans, SSRIs, and SNRIs), cause an increase in serotonin levels. Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea.

Healthcare professionals prescribing a triptan, SSRI or SNRI should keep in mind that triptans are often used intermittently and either the triptan, SSRI or SNRI may be prescribed by a different physician; weigh the potential risk of serotonin syndrome with the expected benefit of using the above combination; discuss the possibility of serotonin syndrome with patients if a triptan and an SSRI or SNRI will be used together; and follow patients closely during treatment if a triptan and an SSRI or SNRI are used together.

Patients taking a triptan along with an SSRI or SNRI should talk to their doctor before stopping their medication and should immediately seek medical attention if they experience any of the above symptoms. FDA requested that all manufacturers of triptans, SSRIs and SNRIs update their prescribing information to warn of the possibility of serotonin syndrome when these medications are taken together.

[July 19, 2006 - Public Health Advisory - FDA]

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Disetronic D-TRONplus Power Packs used in D-TRONplus Insulin Pumps

Audience: Endocrinologists, other healthcare professionals, and consumers
[UPDATE 09/20/2006] Recall classified as Class I because the potential of the pump's power pack to fail may cause serious adverse health consequences, including death.

[Posted 07/14/2006] Disetronic Medical Systems Inc. (Disetronic) and FDA announced a voluntary nationwide recall of the Disetronic D-TRONplus Power Packs, that power the D-TRONplus Insulin Pump. There is the potential that the power pack could shut down the D-TRONplus Insulin Pump without any warning. If a shut down occurs, insulin delivery is interrupted. An interruption in insulin delivery may lead to uncontrolled diabetes mellitus, resulting in hyperglycemia, which may lead to serious patient injury and/or death.

All pump users must put a new power pack into their insulin pump every two weeks to prevent their pump from turning off without any warning. It is important that this two week period not be extended. Disetronic and their distributors will supply power packs free of charge by UPS next day shipment to all D-TRONplus users until corrective actions have been implemented. Every user will receive a power pack together with detailed instructions.

[September 20, 2006 - Recall Notice - FDA]
[July 13, 2006 - Press Release - Disetronic Medical Systems Inc.]
[July 13, 2006 - Urgent Product Recall - Disetronic Medical Systems Inc.]

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Azathioprine Tablets, 50 mg

Audience: Pharmacists and other healthcare professionals
[Posted 07/13/2006] Roxane Laboratories and FDA notified pharmacists and other healthcare professionals of a nationwide recall of a single manufacturing lot of Azathioprine tablets, 50 mg (Lot 558470A, Exp Mar 2009) used to help prevent rejection in kidney transplant patients, and to manage severe rheumatoid arthritis. The recall was initiated due to concerns that bottles from this single lot # 558470A, labeled as Azathioprine may contain Methotrexate, 2.5 mg tablets. Information has been sent to pharmacists alerting them of the details pertaining to this recall. Pharmacists who may have dispensed Azathioprine tablets to patients from manufacturing lot 558470A are instructed to contact those patients to assure they did not inadvertently receive Methotrexate tablets.

[July 13, 2006 – Press Release – Roxane]

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Dietary Supplements Promoted for Sexual Enhancement

Audience: Consumers and healthcare professionals
[Posted 07/13/2006] The FDA notified healthcare professionals and consumers of a warning not to purchase or consume Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON, illegal drugs with undeclared ingredients that are promoted and sold on web sites as "dietary supplements" for treating erectile dysfunction and enhancing sexual performance. These products have not been approved by FDA, and there is no guarantee of their safety and effectiveness, or of the purity of their ingredients. They pose a threat to consumers because the undeclared ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA advises consumers who have used any of these products to discontinue use and to consult their healthcare provider.

[July 12, 2006 – News Release – FDA]

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Baxter Healthcare Colleague Volumetric Infusion Pump
Baxter Healthcare Syndeo Patient Controlled Analgesic Syringe Pump

Audience: Hospital nursing supervisory personnel and risk managers
[UPDATE 02/27/2007] FDA has cleared for marketing a modified Colleague Volumetric Infusion Pump which addresses many of the problems that prompted a series of Class I recalls and a product seizure in 2005. Confusing display screens, software defects, swollen batteries and other defects could have resulted in the pumps either shutting down or under- or over-delivering critical medication and fluids to patients and were associated with serious injuries and deaths.

[Posted 07/07/2006] FDA notified healthcare professionals that Baxter Healthcare will stop manufacturing and distributing all models of Colleague Volumetric Infusion Pump and Syndeo Patient Controlled Analgesic Syringe Pump until the company corrects manufacturing deficiencies and is in compliance with FDA's current good manufacturing practice requirements and the Quality System regulation for devices. FDA will allow the firm to continue to provide routine service maintenance, or to replace components, parts, or accessories for the Colleague and Syndeo Infusion Pumps that were already in the hands of customers before October 12, 2005. The Colleague pump has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm. FDA issued a Preliminary Public Health Notification on April 28, 2006 with recommendations for users, http://www.fda.gov/cdrh/safety/042806‑baxter.html.

[February 27, 2007 – News Release – FDA]
[June 29, 2006 – News Release – FDA]

Previous MedWatch Alerts:

[April 28, 2006]

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Welch Allyn PIC 50 Automated External Defibrillators

Audience: Emergency services personnel and risk managers
[Posted 07/07/2006] MRL, Inc., and FDA notified healthcare professionals of a Class I recall of Welch Allyn PIC 50 Automated External Defibrillators, catalog #97108X manufactured from March 2002 through October 2004. An electrical contact problem may result in the device's failure to provide a defibrillation shock, that could result in delay or failure to resuscitate the patient. This failure may be accompanied by various error messages on the display panel, including the "Defib Comm" error message.

[June 30, 2006 – Recall Notice – FDA]

Related MedWatch Alerts:

[June 12, 2006] Welch Allyn AED20 Automatic External Defibrillators

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Aptivus (tipranavir)

Audience: Infectious disease specialists, pharmacists, and other healthcare professionals
[Posted 06/30/2006] Boehringer Ingelheim and FDA informed healthcare professionals of important new safety information for Aptivus (tipranavir) capsules, co-administered with ritonavir (500mg/200mg), that includes an addition to the drug's Black Box Warning regarding reports of both fatal and non-fatal intracranial hemorrhage (ICH). Boehringer Ingelheim identified 14 reports of intracranial hemorrhage events, including 8 fatalities, in 6,840 HIV-1 infected individuals receiving Aptivus capsules in combination antiretroviral therapy in clinical trials.

Many of the patients experiencing ICH in the Aptivus clinical development program had other medical conditions (CNS lesions, head trauma, recent neurosurgery, coagulopathy, hypertension or alcohol abuse) or were receiving concomitant medications, including anticoagulants and antiplatelet agents, that may have caused or contributed to these events.

No pattern of abnormal coagulation parameters were observed in patients receiving Aptivus in general, or preceding the development of ICH. Routine measurement of coagulation parameters is not currently indicated in the management of patients on Aptivus. An increased risk of ICH was previously observed in patients with advanced HIV-1 disease/AIDS. Further investigations are ongoing to assess the role of Aptivus in ICH.

[June 30, 2006 – Revised Prescribing Information – Boehringer Ingelheim]
[June 30, 2006 – Dear Healthcare Provider Letter – Boehringer Ingelheim]

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Ketek (telithromycin)

Audience: Infectious disease, hepatology and other healthcare professionals
[Posted 06/29/2006] The Food and Drug Administration notified healthcare professionals and patients that it completed its safety assessment of Ketek (telithromycin), indicated for the treatment of acute exacerbation of chronic bronchitis, acute bacterial sinusitis and community acquired pneumonia of mild to moderate severity, including pneumonia caused by resistant strep infections. The drug has been associated with rare cases of serious liver injury and liver failure with four reported deaths and one liver transplant after the administration of the drug. FDA determined that additional warnings are required and the manufacturer is revising the drug labeling to address this safety concern. FDA is advising both patients taking Ketek and their doctors to be on the alert for signs and symptoms of liver problems. Patients experiencing such signs or symptoms should discontinue Ketek and seek medical evaluation, which may include tests for liver function.

[June 29, 2006 – News Release – FDA]

Previous MedWatch Alert
[January 20, 2006]

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Guidant INSIGNIA and NEXUS Pacemakers
Guidant CONTAK RENEWAL TR/TR2 Cardiac Resynchronization Therapy Pacemakers
Guidant VENTAK PRIZM 2, VITALITY and VITALITY 2 Implantable Cardioverter Defibrillators

Audience: Cardiac healthcare professionals, risk managers and biomedical engineers
[Posted 06/26/2006, UPDATED 07/11/2006] Guidant and FDA notified healthcare professionals and patients that a subset of implantable pacemakers, cardiac resynchronization therapy pacemakers and implantable cardioverter defibrillators [ICDs] is associated with five reports of device malfunction due to the failure of a low-voltage capacitor from a single component supplier. Patients with affected pacemakers may experience intermittent or permanent loss of output or telemetry or premature battery depletion. Patients with affected ICDs may experience inappropriate sensing or premature battery depletion. Physicians are asked to perform an exam as soon as possible to assess device function for all patients with implanted devices from this subset.

[April 10, 2007 - Questions & Answers - FDA]
[July 11, 2006 – FDA Statement – FDA]
[June 26, 2006 – Press Release – Boston Scientific/Guidant]
[June 23, 2006 – Letter to Physicians – Guidant]
[June 23, 2006 – Letter to Patients – Guidant]

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Sage Products Inc. Comfort Shield Perineal Care Washcloths

Audience: Hospital and Long-term care facility nursing supervisory staff
[Posted 06/26/2006] Sage Products and FDA notified healthcare professionals of a recall of specific lots of Comfort Shield Perineal Care Washcloths due to contamination with Burkholderia cepacia. Burkholderia cepacia can cause serious infections including pneumonia and bacterial sepsis in immuno-compromised persons, persons with cystic fibrosis, in hospitalized patients in general as well as certain other patient groups. The product was distributed to hospitals, medical centers and long-term care facilities in the U.S. and Canada. There was no known distribution through retail sales.

[June 23, 2006 – Press Release – Sage Products, Inc.]

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Reprocessing of Reusable Ultrasound Transducer Assemblies Used for Biopsy Procedures

Audience: Hospital healthcare professionals, surgical center staff, and risk managers
[Posted 06/20/2006] FDA issued a Public Health Notification regarding the proper cleaning and sterilizing of reusable ultrasound biopsy transducer assemblies (i.e., transducer device and associated accessories). If these devices are not correctly reprocessed between patients, residual material from a previous patient may contaminate the biopsy needle and needle guide when the system is reused for biopsies. This could lead to patient infections. Therefore, the biopsy needle and its containing guide must always be sterilized. This should apply even if a sterile barrier sheath is used on the transducer assemblies during a biopsy procedure, as the sheath is compromised by the penetration of the needle. The Public Health Notification also provides recommendations for cleaning the devices.

[June 19, 2006 – Public Health Notification – FDA]

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Triaminic Vapor Patch

Audience: Pediatricians, other healthcare professionals and consumers
[Posted 06/20/2006] Novartis Consumer Health and FDA notified patients, pharmacists and other healthcare professionals that the sponsor is conducting a nationwide voluntary recall of all Triaminic Vapor Patch products due to reports of serious adverse events associated with accidental ingestion by children. Triaminic Vapor Patch is labeled as a cough suppressant for children two (2) years of age and older and is sold over the counter at pharmacies and retail outlets nationwide. The directions on the label indicate the patch is to be applied to the throat or chest to allow the vapors to reach the nose and mouth. FDA is warning consumers not to use the Triaminic Vapor Patch and is also advising consumers who have used the product and have concerns or questions to contact their physician or health care practitioner.

[June 20, 2006 – Public Health Advisory – FDA]
[June 19, 2006 – Press Release – Novartis]

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Welch Allyn AED20 Automatic External Defibrillators

Audience: Emergency Services personnel and risk managers
[Posted 06/16/2006] MRL, Inc. and FDA notified healthcare professionals of a voluntary worldwide Class I recall of 580 AED20 automatic external defibrillators. An intermittent electrical connection within the device may result in failure or unacceptable delay in analyzing the patient's ECG, failure to deliver appropriate therapy and failure to resuscitate the patient. FDA defines a Class I recall as one in which there is reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.

[June 15, 2006 - Recall Notice - FDA]

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Hamilton Medical, Inc. RAPHAEL Ventilators

Audience: Respiratory healthcare professionals and hospital risk managers
[Posted 06/12/2006] Hamilton Medical, Inc. and FDA notified healthcare professionals of a recall of certain RAPHAEL model ventilators with older generation software, due to a software algorithm designed to suppress false positive alarms that may preclude any alarm (no visible or audible alarms are triggered). The following RAPHAEL ventilators are affected:

RAPHAEL (Software version 2.2x)
RAPHAEL Silver (Software version 2.2xS)
RAPHAEL Color (Software version 2.2xC, 2.2xCU)

[June 06, 2006 - Press Release - Hamilton Medical, Inc.]

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Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI): Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance

Audience: Radiologists, Nephrologists, Dermatologists and other healthcare professionals
[UPDATED 12/22/2006] FDA notified healthcare professionals that the Agency received a total of 69 case reports of patients with moderate to end-stage renal disease who underwent magnetic resonance imaging or magnetic resonance angiography and developed Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD). These reports provide more evidence for a causal relationship between gadolinium-based contrast agents and the development of NSF/NFD.

[Posted 06/08/2006] FDA notified healthcare professionals and consumers that it is evaluating important safety information about gadolinium-containing contrast agents and a disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD) that occurs in patients with kidney failure. New reports have identified a possible link between NSF/NFD and exposure to gadolinium containing contrast agents used at high doses for a procedure called Magnetic Resonance Angiography (MRA). The FDA has learned of 25 cases of NSF/NFD in patients with kidney failure who received Omniscan, a gadolinium-containing contrast agent, and took the MRA test.

The FDA is gathering additional information about NSF/NFD and is actively investigating whether exposure to a gadolinium-contrast agent for MRA is associated with the development of NSF/NFD and whether other patients who received gadolinium-containing contrast agents developed NSF/NFD. FDA has not yet determined whether exposure by patients with kidney failure to these products during an MRA test causes NSF/NFD. The FDA urges health care providers and patients to report adverse event information to the FDA online at http://www.fda.gov/medwatch/report.htm, by phone (1-800-FDA-1088) or by fax (1-800-FDA-0178).

[December 22, 2006  - Drug Information Page - FDA]

[June 08, 2006 - Public Health Advisory - FDA]
[June 08, 2006 - Public Health Advisory - FDA]
[June 06, 2006 - "Dear Healthcare Professional" letter - GE Healthcare]

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Angiotensin-converting enzyme inhibitor (ACE inhibitors) drug class

Audience: Reproductive and other healthcare professionals, patients
[Posted 06/07/2006] The New England Journal of Medicine published an article reporting that infants whose mothers had taken an angiotensin-converting enzyme inhibitor (ACE inhibitors) drug during the first trimester of pregnancy had an increased risk of major congenital malformations, compared with infants who had not undergone first trimester exposure to ACE inhibitor drugs. The FDA-approved labels recommends discontinuing the ACEI as soon as possible if a patient becomes pregnant. ACE inhibitor drugs are labeled pregnancy category C for the first trimester of pregnancy, and are labeled pregnancy category D during the second and third trimesters. Healthcare professionals should take these findings into consideration with other information about a patient’s medical situation when prescribing ACE inhibitors.

At this time, based on this one observational study, the FDA does not plan to change the pregnancy categories for ACE inhibitors. FDA will work with the Agency for Healthcare Quality and Research to identify other potential sources of data that will help determine the degree of risk associated with first trimester exposures to these drugs.

[June 07, 2006 - Drug Information Page - FDA]

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Tysabri (natalizumab)

Audience: Neurological and other healthcare professionals, patients
[UPDATE 07/21/2006] Dear Healthcare Provider Letter issued.

[Posted 06/05/2006] FDA notified healthcare professionals of the resumed marketing, with a special restricted distribution program of Tysabri (natalizumab), a monoclonal antibody for the treatment of patients with relapsing forms of multiple sclerosis. Tysabri was initially approved by the FDA in November 2004, but was withdrawn by the manufacturer in February 2005 after three patients in the drug’s clinical trials developed progressive multifocal leukoencephalopathy (PML), a serious viral infection of the brain. Tysabri will be available only through the Risk Management Plan, called the TOUCH Prescribing Program. In order to receive Tysabri, patients must talk to their doctor and understand the risks and benefits of Tysabri and agree to all of the instructions in the TOUCH Prescribing Program.  

[July 2006 - Letter - Biogen Idec/Elan]
[June 05, 2006 - Drug Information Page - FDA]

Previous MedWatch Alert
[February 28, 2005]

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Boca Medical Ultilet and Closercare Insulin Syringes

Audience: Diabetes healthcare professionals, pharmacists and consumers
[Posted 05/23/2006] Boca Medical Products and FDA notified consumers and healthcare professionals of an extension of an earlier recall of Ultilet Insulin Syringes and the additional recall of Closercare Insulin Syringes because of bacterial contamination with Paenibacillus. This presents a risk of local infection due to soft tissue injection with a contaminated syringe as well a risk of introduction of contaminating organisms into a previously sterile vial.  The introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels. The recall includes Closercare Insulin Syringe 29g 1cc product lot number 5JCZ1 as displayed on the inner case and Ultilet Insulin Syringe 30g 1/2cc, product lot number 5KEO1 as displayed on the inner case. The earlier recall of Ultilet syringes included lot number 5GEXI. This product has been distributed to the following states: FL, NY, MA, AL, SC, NC, CO, TX, MI, AR. 

[May 19, 2006 - Recall Notice - Boca Medical]

Previous MedWatch Alert
[April 17, 2006]

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Tacrolimus Active Pharmaceutical Ingredient [API]

Audience: Pharmacists and organ transplantation healthcare professionals
[Posted 05/18/2006] Spectrum Laboratory Products and FDA notified healthcare professionals of the recall of the active pharmaceutical ingredient tacrolimus, an immunosuppressive drug used to prevent rejections of transplanted solid organs such as heart or kidney, after learning that some lots of the ingredient are subpotent. Spectrum's tacrolimus API has been used by pharmacies for compounding purposes. The use of sub-potent tacrolimus in compounded drugs for transplant recipients may lead to sub-therapeutic tacrolimus blood levels and an unacceptable increased risk of solid organ transplant rejection. Patients receiving tacrolimus for solid organ transplant should not stop taking their medication, but rather should check with their physician or pharmacist. This recall does not apply to tacrolimus marketed in finished dosage form as Prograf (Astellas Pharma, US) or to Prograf oral capsules that have been used for compounding.

[May 11, 2006 - Press Release - Spectrum Laboratory Products]

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Paxil (paroxetine hydrochloride) Tablets and Oral Suspension
Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets

Audience: Neuropsychiatric and other healthcare professionals
[Posted 05/12/2006] GlaxoSmithKline (GSK) and FDA notified healthcare professionals of changes to the Clinical Worsening and Suicide Risk subsection of the WARNINGS section in the prescribing Information for Paxil and Paxil CR. These labeling changes relate to adult patients, particularly those who are younger adults.

A recent meta-analysis conducted of suicidal behavior and ideation in placebo-controlled clinical trials of paroxetine in adult patients with psychiatric disorders including Major Depressive Disorder (MDD), other depression and non-depression disorders. Results of this analysis showed a higher frequency of suicidal behavior in young adults treated with paroxetine compared with placebo. Further, in the analysis of adults with MDD (all ages), the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo. This difference was statistically significant; however, as the absolute number and incidence of events are small, these data should be interpreted with caution. All of the reported events of suicidal behavior in the adult patients with MDD were non-fatal suicide attempts, and the majority of these attempts (8 of 11) were in younger adults aged 18-30. These MDD data suggest that the higher frequency observed in the younger adult population across psychiatric disorders may extend beyond the age of 24.

It is important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated.

[May 2006 - Dear Healthcare Professional letter - GlaxoSmithKline]
[April 2006 - Paxil Label - GlaxoSmithKline]
[April 2006 - Paxil CR Label - GlaxoSmithKline]

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Respironics PLV Continuum Ventilator (PLVC I)

Audience: Respiratory healthcare professionals, hospital risk managers and biomedical engineers
[Posted 05/05/2006] Respironics and FDA notified healthcare professionals about the Class 1 recall of this device, a mechanical ventilator used to control or assist breathing. The ventilator is intended for home, institutional and portable settings and may be used for invasive as well as noninvasive ventilation. A design flaw can cause lead wires in the air flow valve to break during use. When this happens the ventilator stops providing mechanical ventilation. Customers should safely transition patients in their care from the PLV Continuum Ventilator onto other comparable patient support devices. If customers do not have a suitable ventilator to use for their patients, they should contact Respironics at 760-918-7328 to make suitable substitute arrangements.

[May 05, 2006 -Class 1 Recall - FDA]

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Oral Sodium Phosphate (OSP) Products for Bowel Cleansing

Audience: Consumers, pharmacists and other healthcare professionals
[Posted 05/05/2006] FDA notified healthcare professionals and consumers of reports of acute phosphate nephropathy, a type of acute renal failure, that is a rare, but serious adverse event associated with the use of oral sodium phosphates (OSP) for bowel cleansing.  Documented cases of acute phosphate nephropathy include 21 patients who used an OSP solution (such as Fleet  Phospho-soda or Fleet ACCU-PREP) and one patient who used OSP tablets (Visicol). Individuals at increased risk of acute phosphate nephropathy include: those of advanced age, those with kidney disease or decreased intravascular volume, and those using medicines that affect renal perfusion or function [diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and possibly nonsteroidal anti-inflammatory drugs (NSAIDs)]. Recommendations were offered for providers and patients when choosing and using a bowel cleanser.

[May 05, 2006 - Drug Information Page - FDA]

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Goldline Brand Extra Strength Genapap and Extra Strength Genebs (Acetaminophen 500 mg)

Audience: Consumers and pharmacists
[Posted 05/03/2006] FDA and IVAX Pharmaceuticals, Inc. notified healthcare professionals of a recall of Goldline brand Extra Strength Genapap 500mg (Acetaminophen) Caplets and Tablets and Extra Strength Genebs 500mg (Acetaminophen) Caplets and Tablets due to a labeling error. Specifically, the product label should indicate that usage should not exceed 8 tablets or caplets in a 24 hour period. The erroneous label indicates not to exceed 12 tablets or caplets in a 24 hour period. In the event the maximum dosage of 8 tablets or caplets in a 24 hour period is exceeded, there may be an increased risk of acetaminophen toxicity to the liver, which may cause adverse health effects. There have been no reports of serious illness or injury relating to this labeling matter.

[May 02, 2006 - Recall Notice - IVAX Pharmaceuticals, Inc.]

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NeutraGard 0.05% and NeutraGard Plus 0.2% Neutral Sodium Fluoride Anticavity Treatment Rinse

Audience: Dentists, dental hygienists, and consumers
[Posted 04/28/2006] Pascal Company, Inc. recalled all lots and all flavors of NeutraGard 0.05% Neutral Sodium Fluoride Anticavity Treatment Rinse and NeutraGard Plus 0.2% Neutral Sodium Fluoride Anticavity Treatment Rinse packaged in clear 16 oz plastic bottles. The products were recalled because they may be contaminated with Burkholderia cepacia and Pseudomonas aeruginosa bacteria.

Burkholderia cepacia (B. cepacia) bacteria poses little medical risk to healthy people. However, the bacteria may affect individuals with certain health problems like a weakened immune system or chronic lung diseases, such as cystic fibrosis. The effects of B. cepacia range from no symptoms to serious respiratory infections, especially in patients with cystic fibrosis.

Pseudomonas aeruginosa may cause urinary track infections, respiratory system infections, dermatitis, soft tissue infections, bacteremia, bone and joint infections, gastrointestinal infections and a variety of systemic infections, particularly in patients with severe burns and in cancer and AIDS patients.

Dental offices and consumers who have the product should discontinue use and destroy it or return the product to the place of purchase for further processing.

[April 27, 2006 - Recall Notice - Pascal Company, Inc.]

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Baxter Healthcare Corporation COLLEAGUE Volumetric Infusion Pumps

Audience: All healthcare providers, risk managers, and biomedical engineers
[Posted 04/28/2006] The FDA is recommending that all healthcare providers take important safety steps when using the COLLEAGUE Volumetric Infusion Pump manufactured by Baxter Healthcare Corporation. The COLLEAGUE pump has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm. Over the past year, Baxter has issued four urgent safety notices and recalls for COLLEAGUE infusion pumps.

In addition to the recommendations made by Baxter Healthcare Corporation when using the COLLEAGUE Volumetric Infusion Pump, FDA is strongly recommending the following measures:

- Do not use the COLLEAGUE pumps in situations where delaying or interrupting therapy in order to reprogram or replace a malfunctioning pump may be life threatening, if possible.

- Have a contingency plan to mitigate any disruption of infusion therapy (e.g., have a back-up pump available).

- Monitor patients and check the pumps frequently.

- Report any problems as soon as possible to Baxter and FDA.

- Consider evaluating other options for infusion therapy if your facility relies primarily or entirely on COLLEAGUE Pumps.

Other short-term options that may be appropriate for certain IV therapies include gravity drip and flow control devices (e.g., buretrol, volutrol, micro tubing, and flow control tubing devices). FDA is mindful of concerns about the availability of replacement units and is working with Baxter to resolve problems with the COLLEAGUE pump as quickly as possible.

[April 28, 2005 - Preliminary Public Health Notification - FDA]

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Promethazine HCl (marketed as Phenergan and generic products)

Audience: Pediatricians, emergency service professionals and patients
[Posted 04/25/2006] FDA notified healthcare professionals and patients that cases of breathing problems, some causing death, have been reported to the FDA when the drug was used in children less than two years old. Parents and caregivers should also be careful and get a doctor's advice about giving promethazine HCl in any form to children age two and older. The labeling on all products, brand name and generic, has been changed to reflect these strengthened warnings.

[April 25, 2006 - Drug Information Page - FDA]

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Oxygen Regulator Fires Resulting from Incorrect Use of CGA 870 Seals

Audience: Hospital risk managers and nursing supervisory staff
[UPDATE posted 06/20/2006] FDA and NIOSH clarified recommendations on the use of sealing- type washers (reusable, metal-bound rubber seal) and crush-type gaskets (single use, not reusable, usually Nylon) with oxygen regulators. This update also provides additional recommendations on the proper use of both the plastic seals and rubber/metal seals.

[Posted 04/25/2006] FDA and NIOSH (National Institute for Occupational Safety and Health) notified healthcare professionals that twelve incidents have been reported in which regulators used with oxygen cylinders have burned or exploded, in some cases injuring personnel. Some of the incidents occurred during emergency medical use or during routine equipment checks. FDA and NIOSH believe that improper use of gaskets/washers in these regulators was a major factor in both the ignition and severity of the fires, although there are likely other contributing factors. FDA and NIOSH recommend that plastic crush gaskets never be reused, as they may require additional torque to obtain the necessary seal with each subsequent use. This can deform the gasket, increasing the likelihood that oxygen will leak around the seal and ignite.

[April 24, 2006 - Public Health Notification - FDA]

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Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Signal Reagent

Audience: Diagnostic laboratory managers and hospital risk managers
[Posted 04/18/2006] Ortho-Clinical Diagnostics and FDA notified healthcare professionals of a Class 1 recall of this reagent, a special chemical used with the VITROS Immunodiagnostic ECi/ECiQ System to screen patient samples and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B or C), thyroid disorders, HIV and pregnancy. A decreased signal in the reagent may produce inaccurate results in some cases, affecting the outcome of the diagnostic tests.

Customers with the affected lot numbers should discontinue using any remaining reagent and should follow the enhanced Quality Control (QC) procedure provided by Ortho-Clinical Diagnostic for each pack in all lots of VITROS Signal Reagent until further notice. Patients who have had diagnostic testing performed for any of these medical conditions within the last 60 days and are concerned with their test results should discuss them with their physicians - cardiac disease, hepatitis (A,B, or C), thyroid disorders, HIV and pregnancy.

[April 18, 2006 - Class 1 Recall - FDA]
 

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Boca Medical Ultilet Insulin Syringe 30g 1/2cc

Audience: Diabetes healthcare professionals, pharmacists and consumers
[Posted 04/17/2006] Boca Medical Products and FDA notified consumers and healthcare professionals of a recall of Ultilet Insulin Syringe 30g 1/2cc (Lot # - 5GEXI, NDC # - 08326-3002-50) because of possible bacterial presence of Bacillus Cereus and Staphylococcus Intermedius.  This presents a risk of local infection due to soft tissue injection with a contaminated syringe as well a risk of introduction of contaminating organisms into a previously sterile vial.  The introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels. This product has been distributed to the following states: FL, NY, MA, AL, SC, NC, CO, TX, MI, AR.  For any question related to the case consumers should call 1-800-354-8460.

[April 13, 2006 - Press Release - Boca Medical]


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Blackstone Medical ICON Modular Fixation System

Audience: Neurosurgical healthcare professionals, surgical service managers and hospital risk managers
[Posted 04/17/2006] Blackstone Medical, Inc. and FDA notified healthcare professionals about a recall of its ICON Modular Fixation System, a collection of components that allows the surgeon to assemble a construct including screws, connectors and rods. The construct is implanted in and near the patient's spine, and is intended to immobilize and stabilize spinal segments at the site of spine surgery.  The pedicle (vertebra stem) screws may separate from the screw heads, or from the rods that run between spinal segments. If this happens soon after the surgery, the spine may not fuse properly, and patients may need additional surgery to correct the problem. If not corrected, some patients may experience long-term pain and disability. The potential for injury depends on the specific condition being treated, and the degree of postoperative healing.  Blackstone Medical, Inc. is requesting that hospitals and surgeons review their records to identify patients who have the recalled products, and to contact these patients.  Patients who may have concerns regarding their ICON fixation devices should contact the physician who is providing postoperative care.

[April 12, 2006 - Press Release - Blackstone Medical]
[April 17, 2006 - Class 1 Recall - FDA]


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Fungal Keratitis Infections Related to Contact Lens Use

Audience: Ophthalmologists, Optometrists, pharmacists, other healthcare practitioners, and consumers
[UPDATE 05/31/2006] On May 15, 2006, Bausch and Lomb announced its decision to permanently remove all ReNu with MoistureLoc products worldwide. As previously recommended, consumers should stop using ReNu with MoistureLoc immediately.

[Posted 04/11/2006; UPDATE 05/15/2006] The FDA and CDC notified all healthcare practitioners and consumers of an increase in the number of reports in the United States of a rare but serious fungal infection of the eye in soft contact lens wearers. The infection, a fungal keratitis caused by the Fusarium fungus, may cause vision loss requiring corneal transplants.

Both the FDA and CDC are investigating these occurrences. The CDC received reports of 109 cases of suspected fungal keratitis in 17 different States. Twenty-eight of the 30 cases reported wearing soft contact lenses. The majority of the individuals (26) reported using a Bausch & Lomb ReNu brand contact lens solution in the month prior to the onset of infection.

Healthcare practitioners should refer patients presenting with a microbial keratitis immediately to an ophthalmologist for immediate treatment and report cases of fungal keratitis in contact lens wearers to FDA. Contact lens wearers should use good hygiene practices, e.g., wash hands with soap and water, and dry (lint free method) before handling lenses; wear and replace lenses according to the prescribed schedule; follow the specific lens cleaning and storage guidelines from the doctor and the solution manufacturer; keep the contact lens case clean and replace every 3-6 months; and remove lenses and consult a doctor immediately if the wearer experiences symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling.

[May 31, 2006 - Public Health Notification - FDA]
[May 15, 2006 - Statement - FDA]
[May 05, 2006 - Update - FDA]
[April 10, 2006 - Advice to Patients - FDA]
[April 10, 2006 - Press Release - FDA]
[April 10, 2006 - MMWR Dispatch - CDC]

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Macugen (pegaptanib sodium injection)

Audience: Ophthalmological healthcare professionals, surgical service supervisors and other healthcare professionals
[Posted 04/07/2006] (OSI)Eyetech/Pfizer and FDA notified healthcare professionals of important changes in the approved product labeling for Macugen (pegaptanib sodium injection), including changes to the CONTRAINDICATIONS, PRECAUTIONS, ADVERSE EVENTS Post-Marketing, and DOSAGE and ADMINISTRATION sections. Rare reports of anaphylaxis/anaphylactoid reactions, including angioedema following the administration of Macugen along with various medications administered as part of the injection preparation, were described. Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration, and is administered once every six weeks by intravitreous injection. Healthcare professionals should evaluate the patient's medical history for hypersensitivity reactions to Macugen prior to using this product.

[March 6, 2006 - Dear Healthcare Professional Letter - (OSI)Eyetech/Pfizer]
[March 8, 2006 - Label - (OSI)Eyetech/Pfizer]
 

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Disetronic Medical Systems, Inc. ACCU-CHEK Ultraflex Infusion Sets

Audience: Endocrinologists, pharmacists, other healthcare professionals, and consumers
[UPDATED 07/24/2006] Recall classified as class 1 due to potential for interruption of insulin delivery and resulting hyperglycemia.

[Posted 04/04/2006] Disetronic Medical Systems, Inc. announced a voluntary nationwide recall of all ACCU-CHEK Ultraflex Infusion Sets because of a potential that tubing could fully or partially separate at the luer lock-tubing connection. In the event a full or partial separation occurs, insulin may leak from the infusion set tubing causing an interruption of insulin delivery, which can cause hyperglycemia.

The symptoms of hyperglycemia include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue/tiredness/sleepiness, headache, fruity acetone breath and abdominal pain. Patients experiencing these symptoms are advised to check their blood glucose to ensure that the blood glucose level is within an acceptable range as defined by the patient's healthcare team and follow the medical advice given by the healthcare professional or contact their physician.

Under this recall, customers have the option of replacing their ACCU-CHECK Ultraflex infusion sets, or using the ACCU-CHEK Tender or ACCU-CHEK Rapid-D infusion sets. For additional customer advice regarding this recall, please see the Disetronic Medical Systems, Inc. recall notice.

[July 20, 2006 - Recall Notice - FDA]
[April 04, 2006 - Press Release - Disetronic Medical Systems, Inc.]
 

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Ossur Total Knee prosthetic device

Audience: Orthopedic surgeons, hospital surgical service managers and risk managers
[Posted 03/31/2006] Ossur and FDA notified healthcare professionals of a voluntary worldwide recall of the 1100, 1900, 2000 and 2100 models of its Total Knee prosthetic device. The company's initiation of the recall is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee. At this time, there have been no incidents or injuries resulting from this situation that have been reported to the company.

[March 31, 2006 - Press Release - Ossur]
 

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Diastat AcuDial (diazepam rectal gel)

Audience: Neurologists, pharmacists and consumers
[Posted 03/30/2006] Valeant Pharmaceuticals International and FDA notified healthcare professionals of complaints the company received concerning small cracks at the base of the plastic tip of the applicators with resulting leakage of the medication when the plunger is depressed, preventing full dosing and potentially resulting in a sub-optimal therapeutic response. Diastat is indicated for rectal administration in the management of selected refractory patients with epilepsy on stable regimens of anti-epileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity. Complaints were received for the Diastat AcuDial Applicators 10mg and 20mg product twin packs.

Healthcare professionals should advise patients using the product of this issue and to return any product with a cracked tip to their pharmacy for immediate replacement. Pharmacists should inspect all product on their shelves and contact Rx Hope at 1-800-511-2120 or www.Rxhope.com for replacement product. Emergency support should always be available in case seizures are not controllable with Diastat AcuDial.

[March 30, 2006 - Drug Information Page - FDA]
[February 21, 2006 - Dear Doctor Letter - Valeant]
[February 21, 2006 - Dear Pharmacist Letter - Valeant]
 

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Mifeprex (mifepristone)

Audience: Reproductive healthcare professionals and consumers
[Posted 03/17/2006] The FDA notified healthcare professionals of two additional deaths following medical abortion with mifepristone (Mifeprex).  The Agency received verbal notification of the deaths in the United States from the manufacturer, Danco Laboratories. At this time we are investigating all circumstances associated with these cases and are not able to confirm the causes of death. However, all providers of medical abortion and their patients need to be aware of the specific circumstances and directions for use of this drug and all risks including sepsis when considering treatment. In particular, physicians and their patients should fully discuss early potential signs and symptoms that may warrant immediate medical evaluation.

[March 17, 2006 – Public Health Advisory – FDA]
[March 17, 2006 (UPDATE April 10, 2006) - Drug Information Page – FDA]

Previous MedWatch Alerts:
[July 19, 2005]
[November 11, 2004]

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Ontak (denileukin diftitox)

Audience: Hemato-oncological healthcare professionals
[Posted 03/15/2006] Ligand Pharmaceuticals and FDA notified healthcare professionals of changes to the WARNINGS section of the prescribing information for Ontak, indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma. Loss of visual acuity, usually with loss of color vision, has been reported following administration of Ontak. While recovery was reported in some of the affected patients, most patients reported persistent visual impairment.

[March 03, 2006 – Letter – Ligand]
[February 2006 – Label – Ligand]

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Illegal Steroid Products Sold as Dietary Supplements

Audience: Healthcare professionals and consumers
[Posted 03/10/2006] The FDA warned several manufacturers and distributors of unapproved drugs containing steroids that are marketed as dietary supplements and promoted for building muscle and increasing strength that the products may cause serious long-term adverse health consequences in men, women, and children. These products claim to be anabolic and problems associated with anabolic steroids include: liver toxicity, testicular atrophy and male infertility, masculinization of women, breast enlargement in males, and short stature in children. Anabolic steroids are also associated with causing adverse effects on blood lipid levels, and a potential to increase the risk of heart attack and stroke.

Consumers who have any of the following products should stop taking them and return them to their place of purchase:

Anabolic Xtreme Superdrol - manufactured for Anabolic Resources LLC, Gilbert, Arizona
Methyl-1-P, manufactured for Legal Gear, Brighton, MI

[March 09, 2006 – Press Release – FDA]

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Hospital Bed Entrapments

Audience: Hospital risk managers and supervisory nursing service staff
[Posted 03/09/2006] The Food and Drug Administration issued a guidance designed to reduce the occurrence of hospital bed entrapments that occur when part of a patient's body becomes caught between parts of the bed, such as in the space between the mattress and the side rail. This can cause strangulation and death. Entrapments have occurred in a variety of patient care settings, including hospitals, nursing homes, and private homes. The guidance identifies special issues associated with hospital bed systems, provides design recommendations for manufacturers of new hospital beds and provides suggestions for health care facilities on ways to assess existing beds for potential entrapment risks.

[March 09, 2006 – News Release – FDA]
[March 09, 2006 – Hospital Bed Safety page – FDA]

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Davol/Bard Composix Kugel Mesh Patch

Audience: Surgeons, surgical service personnel and hospital risk managers
[UPDATE 3/31/2006] Davol/Bard and FDA notified healthcare professionals of an expanded recall of this product to include Oval, Large Oval and Large Circle Kugel mesh patches.  Bard also issued letters to hospitals and health care professionals providing updated Instructions for Use, clarifying the proper insertion technique and offering supplemental patient management information.

[Posted 03/02/2006] Bard/Davol and FDA notified healthcare professionals of a class 1 recall of Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The "memory recoil ring" that opens the Composix Kugel Mesh Patch after it has been inserted into the intra-abdominal space can break. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

[March 31, 2006 – Recall Notice – FDA]
[March 24, 2006 – Dear Chief of Surgery letter –Davol/Bard]
[March 24, 2006 – Dear Hospital Administrator letter –Davol/Bard]
[March 24, 2006 – Dear Distributor letter –Davol/Bard]

[March 02, 2006 – Previous Recall Notice – FDA]

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Human tissue recovered by Biomedical Tissue Services, Ltd. (BTS)

Audience: Surgeons, surgical supervisory personnel and hospital risk managers
[Posted 03/02/2006] FDA notified healthcare professionals of an update to the October 26, 2005 information paper on human tissues recoved by BioMedical Tissue Services (BTS). The tissue, including human bone, skin, and tendons, was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases. As part of its ongoing investigation, FDA has become aware of additional information regarding the reliability of donor blood samples that is important for health care providers to consider. FDA strongly recommends that health care providers inform their patients who received tissue implants prepared from BTS donors that they may be at increased risk of communicable disease transmission and to offer them testing. While FDA believes the risks from these tissues are low because the tissues were routinely processed using methods to help to reduce the risk of infectious disease, the actual infectious risk is unknown.

[March 02, 2006 – Public Health Notification – FDA]
[February 03, 2006 – Order to Cease Manufacturing – FDA]
[October 26, 2005 – Information Paper – FDA]

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Tracleer (bosentan)

Audience: Cardiopulmonary healthcare professionals
[Posted 03/02/2006] Actelion and FDA notified healthcare professionals of changes to the prescribing information based on cases of hepatotoxity reported. The notification underscored the need to continue monthly liver function monitoring for the duration of Tracleer treatment and the need to adhere to the recommended dosage adjustment and monitoring guidelines described in the product labeling.

[March 01, 2006 – Letter – Actelion]
[March 2006 – Label and Medication Guide – Actelion]

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Cefazolin for Injection

Audience: Healthcare professionals and hosptal risk managers
[Posted 03/01/2006] Hanford Pharmaceuticals and FDA notified healthcare professionals about the recall of four lots (379,975 vials) of Cefazolin for Injection, USP, 1 g/10 mL vials, an antibiotic used in a hospital environment to treat skin and skin structure, respiratory and other infections.The product was distributed by Sandoz, Inc. of Broomfield, CO and Watson Pharmaceuticals, Inc. of Corona, CA. Certain lots of the active ingredient used to manufacture the product have been shown to contain microbial contamination (Bacillus pumilus, Staphylococcus hominis, Propionibacterium acnes, or Micrococcus luteus) which may pose a serious or life-threatening risk for some patients.  Hospitals, clinics, and users should stop using the affected lots immediately.

[February 2006 – Press Release –G.C. Hanford Manufacturing Co.]

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Mead Johnson GENTLEASE powdered infant formula

Audience:  Consumers and pediatric healthcare professionals
[Posted 02/22/2006] Mead Johnson and FDA notified consumers and healthcare professionals of a recall of one lot, lot # BMJ19, of GENTLEASE powdered infant formula, found to contain metal particles up to 2.7 millimeter in size. If an infant were to inhale the infant formula into the lungs, the presence of these particles could present a serious risk to the infant's respiratory system and throat. There were approximately 41,464 24-ounce cans of this lot of recalled product distributed, beginning on December 16, 2005, through many major retail stores across the country, so the consumer should concentrate on the code on the can rather than on the place of purchase. The affected products can be identified by the lot number and expiration/use by date embossed on the bottom of the can of BMJ19, use by 1 Jul 07. Consumers who have a can of this batch of GENTLEASE powdered infant formula should not use the product and should contact Mead Johnson at 888-587-7275 immediately.

[February 22, 2006 - News Release - FDA]

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Tequin (gatifloxacin)

Audience: Healthcare professionals and patients
[Posted 02/16/2006] BMS notified FDA and healthcare professionals about proposed changes to the prescribing information for Tequin, including an updating of the existing WARNING on hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), and a CONTRAINDICATION for use in diabetic patients. The changes also include information identifying other risk factors for developing low blood sugar and high blood sugar, including advanced age, renal insufficiency, and concomitant glucose-altering medications while taking Tequin. The proposed changes are highlighted in the following "Dear Healthcare Provider" letter issued by BMS. Specific wording of these additions and revisions to the labeling is pending FDA review and approval.

[February 15, 2006 – Letter – BMS]
[January 2006 – Label – BMS]

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Nimotop (nimodipine)

Audience: Neurosurgical, intensivist and other healthcare professionals
[Posted 02/15/2006] Bayer and FDA notified healthcare professionals of changes to the prescribing information for nimodipine (Nimotop), including a boxed warning to notify prescribers about medication administration errors with nimodipine. Nimodipine is approved for oral administration to improve neurological outcome after subarachnoid hemorrhage. When administered intravenously or parenterally, it can cause serious adverse events, including death. Nimodipine must not be administered intravenously or by any parenteral route.

[February 2006 – Letter – Bayer]
[January 2006 – Label – Bayer]
[February 2006 – Drug Information Page – FDA]

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Cytosol Laboratories, Inc. Balanced Salt Solution (BSS)

Audience: Ophthalmologists, operating room supervisory staff and other healthcare professionals
[Posted 02/14/2006] FDA notified healthcare professionals and patients of the request for recall of all brands and sizes of Balanced Salt Solution (BSS) manufactured by Cytosol Laboratories, Inc. because product lots were found to have elevated and dangerous levels of endotoxin. BSS is a drug used by health professionals to irrigate a patient’s eyes, ears, nose and/or throat during a variety of surgical procedures including cataract surgery. FDA has received reports of a serious and potentially irreversible eye injury called Toxic Anterior Segment Syndrome (TASS) which occurs when a contaminant, such as endotoxin, enters the anterior segment of the eye during surgery and causes an inflammatory reaction.  FDA has also received complaints relating to injuries in over 300 patients who were given BSS manufactured by Cytosol Laboratories The BSS products subject to the recall order were manufactured by Cytosol Laboratories, Inc. for distribution under three labels:

"AMO Endosol" distributed by Advanced Medical Optics, Inc. (AMO), Santa Ana, Calif.;
"Cytosol Ophthalmics" distributed by Cytosol Ophthalmics, Lenoir, NC; and
"Akorn" distributed by Akorn, Inc., Buffalo Grove, Ill.

[February 13, 2006 – News Release – FDA]

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Benzocaine sprays

Audience: Healthcare professionals and patients
[Posted 02/13/2006] FDA issued a Public Health Advisory to notify healthcare professionals and patients about adverse events, including methemoglobinemia, associated with the use of benzocaine sprays used in the mouth and throat. Benzocaine sprays are used in medical practice for locally numbing mucous membranes of the mouth and throat for minor surgical procedures or when a tube must be inserted into the stomach or airways.  On February 8, 2006, the Veterans Health Administration (VA) announced the decision to stop using benzocaine sprays for these purposes. The FDA is aware of the reported adverse events and is reviewing all available safety data, but at this time is not planning action to remove the drugs from the market. The FDA is highlighting safety information previously addressed by the Agency (see below), has provided other information for the consideration of clinicians in the PHA and will make further announcements or take action as warranted by the ongoing review.

[February 10, 2006 – Public Health Advisory – FDA]
[January 2003 - FDA Patient Safety News - FDA]

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Trasylol (aprotinin)

Audience: Cardiovascular and other healthcare professionals
[UPDATED 12/15/2006] FDA and Bayer Pharmaceuticals notified healthcare professionals of revisions to the prescribing information for Trasylol. The new labeling has a more focused indication, a new Warning that Trasylol administration increases the risk of renal dysfunction and may increase the need for dialysis in the perioperative period, and stronger warnings about anaphylactic reactions. In addition, due to the higher risk for anaphylactic reactions, re-administration of Trasylol to patients with a known or suspected exposure during the past 12 months is contraindicated.

[UPDATED 09/29/2006] FDA held a public advisory committee meeting September 21, 2006 to discuss the safety and overall risk-benefit profile for Trasylol. The committee discussed the findings from the two published observational studies, the Bayer worldwide safety review, and the FDA review of its own post-marketing database. On September 27, 2006, Bayer told FDA that it had conducted an additional safety study of Trasylol. The preliminary findings from this new observational study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes. While FDA conducts its evaluation of this new safety study, it is recommended that physicians should consider limiting Trasylol use to those situations where the clinical benefit of reduced blood loss is essential to medical management and outweighs the potential risks. Physicians should carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart, or brain, and promptly report observed adverse event information to FDA's MedWatch program or Bayer.

[Posted 02/08/2006] FDA issued a public health advisory and other advisory information to notify both healthcare professionals and consumers of recently published studies of serious renal and cardiovascular toxicity following Trasylol administration to patients undergoing coronary artery bypass grafting surgery (CABG). An observational study published in The New England Journal of Medicine reported that Trasylol may be associated with increased risk of myocardial infarction, stroke and renal dysfunction. Another publication (Transfusion, on-line edition, January 20, 2006) has reported that Trasylol administration may increase the risk for renal toxicity.

The FDA is working with the authors of the publications and the manufacturer of Trasylol to carefully evaluate the risks and benefits associated with use of Trasylol in CABG. The FDA anticipates the public presentation of the recently reported information and other data at an advisory committee in the near future. The FDA will notify health care providers and patients in a timely fashion as new information becomes available.

[December 15, 2006 – Revised Label –Bayer]
[December 15, 2006 – Healthcare Professional Sheet – FDA]
[December 15, 2006 – Drug Information Page – FDA]

[September 29, 2006 – Public Health Advisory – FDA]
[September 29, 2006 – Healthcare Professional Information Sheet – FDA]

[February 08, 2006 – Public Health Advisory – FDA]
[February 08, 2006 – Trasylol Information Page – FDA]

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Cochlear Implants with a Positioner

Audience: ENT healthcare professionals, pediatricians and infectious disease practitioners, and patients
[Posted 02/06/2006] FDA notified healthcare professionals and patients about a Public Health Notification on continued risk of bacterial meningitis in children with cochlear implants. The notification provides new information about the risk of meningitis in children with cochlear implants beyond twenty-four months post-implantation. This new information is based on a CDC study that published in this month's issue of Pediatrics and updates previous FDA notifications from 2002 and 2003.

[February 06, 2006 – Public Health Notification – FDA]
[February 06, 2006 – Advice for Patients with Cochlear Implants – FDA]

Previous MedWatch Alerts:

[July 24, 2002]

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Baxter Healthcare Corp. COLLEAGUE and COLLEAGUE CX Volumetric Infusion Pumps

Audience: Hospital nursing supervisory personnel and risk managers
[Posted 02/02/2006] Baxter Healthcare Corp. and FDA notified healthcare professionals of a Class 1 recall of all models of COLLEAGUE Volumetric Infusion Pumps, used to give controlled amounts of medications or other fluids to patients through an intravenous, intra-arterial, epidural or other direct line into the bloodstream. Reasons for the recall include one or more of the following conditions: battery undercharging, false alarms/shutdown, gearbox wear, under-infusion, and/or non-detection of upstream occlusion. Any of these failures may delay or interrupt therapy, which could result in a life-threatening situation for patients, depending on the type of therapy being administered.

[February 02, 2006 – Recall Notice – FDA]

Previous MedWatch Alerts:

[July 21, 2005]

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Boston Scientific Flextome Cutting Balloon Systems

Audience: Interventional cardiology healthcare professionals and risk managers
[Posted 02/02/2006] Boston Scientific and FDA notified healthcare professionals of the class 1 recall of the Flextome Cutting Balloon system, used to open blocked arteries or blood vessels. The catheter shaft used to place the balloon in the artery may separate during withdrawal of the device from the patient. If that happens, the procedure may be prolonged, or more in-depth surgery may be required to remove the broken-off piece from the artery.

[January 31, 2006 – Recall Notice – FDA]

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The First Years Liquid-Filled Teethers

Audience: Consumers and healthcare professionals
[Posted 01/30/2006] The First Years and FDA notified consumers and healthcare professionals of the voluntary recall of liquid-filled teethers due to possible bacterial contamination. The liquid inside the teethers may contain pseudomonas aeruginosa and pseudomonas putida which can cause serious illness in children if the teether is punctured and the liquid from the teether is ingested. The teethers were sold nationwide including major retailers, grocery, drug and specialty stores from July 2005 to January 2006. This recall is for 6 different styles of liquid-filled teethers for infants (3+ months old) to soothe gums. Consumers should stop using the recalled products immediately. No illnesses have been reported to date in connection with this problem.

[February 09, 2006 – Recall Notice – FDA]
[February 09, 2006 – News Release – FDA]
[January 27, 2006 – Recall Notice – The First Years]
[January 30, 2006 - Images of Recalled Teethers]

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Vapotherm 2000i and 2000h Respiratory Gas Humidifier

Audience: Neonatologists, respiratory healthcare professionals and hospital clinical managers
[Posted 01/30/2006] Vapotherm, Inc. and FDA notified healthcare professionals about the class 1 recall of the Vapotherm 2000i and 2000h products, which deliver moisture to and warm breathing gases through a flexible nasal tube for patients receiving supplemental oxygen in home, hospital or sub-acute institutional settings. FDA received reports of Vapotherm units becoming contaminated with Ralstonia spp and other bacteria. Exposure to these bacteria may cause patients to develop tracheitis, sepsis, pneumonia, or other serious infections. There is a reasonable probability that immunocompromised patients or premature newborms could develop pneumonia or sepsis. FDA recommends the use of alternative devices until the source of the contamination has been identified. Patients who have been exposed to the Vapotherm system should be monitored for signs and symptoms that may suggest infection and clinicians may want to consider Ralstonia infection in the differential diagnosis of symptomatic patients even if the organism has not been isolated.

[January 27, 2006 – Recall Notice – FDA]
[January 24, 2006 – Press Release –Vapotherm, Inc.]

Previous FDA/MedWatch alerts

[December 20, 2005]

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Hydrea (hydroxyurea capsules)
Droxia (hydroxyurea capsules)

Audience: Pharmacists and Oncological healthcare professionals
[Posted 01/26/2006] Bristol-Myers Squibb notified healthcare professionals about revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information to describe cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, in patients with myeloproliferative disorders during therapy with hydroxyurea, most often reported in patients with a history of or currently receiving interferon therapy. The PRECAUTIONS and DOSING AND ADMINISTRATION sections have been revised to provide updated information on the safe handling of these products.

The proposed changes are highlighted in the following "Dear Healthcare Provider" letters issued January 2006 by Bristol-Myers Squibb; specific wording of these additions and revisions to the labeling is pending FDA review and approval.

[January 20, 2006 – Hydrea letter – Bristol-Myers Squibb]
[January 20, 2006 – Droxia letter – Bristol-Myers Squibb]

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Ketek (telithromycin)

Audience: Infectious Disease, Hepatology and other healthcare professionals
[Posted 01/20/2006] Annals of Internal Medicine published an article reporting three patients who experienced serious liver toxicity following administration of Ketek (telithromycin). These cases were also reported to FDA MedWatch. Telithromycin is marketed and used extensively in many other countries, including countries in Europe and Japan. While it is difficult to determine the actual frequency of adverse events from voluntary reporting systems such as the MedWatch program, the FDA is continuing to evaluate the issue of liver problems in association with use of telithromycin in order to determine if labeling changes or other actions are warranted. As a part of this, FDA is continuing to work to understand better the frequency of liver-related adverse events reported for approved antibiotics, including telithromycin.

[January 20, 2006 – Public Health Advisory – FDA]
[January 20, 2006 – Questions and Answers – FDA]

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Elidel Cream (pimecrolimus)
Protopic Ointment (tacrolimus)

Audience: Dermatological and other healthcare professionals
[Posted 01/20/2006] The Food and Drug Administration announced the approval of updated labeling for two topical eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus). The labeling will be updated with a boxed warning about a possible risk of cancer and a Medication Guide (FDA-approved patient labeling) will be distributed to help ensure that patients using these prescription medicines are aware of this concern. The new labeling also clarifies that these drugs are recommended for use as second-line treatments. This means that other prescription topical medicines should be tried first. Use of these drugs in children under 2 years of age is not recommended.

[January 19, 2006 – Elidel Information Page – FDA]
[January 19, 2006 – Protopic Information Page – FDA]
[January 27, 2006 – Elidel letter – FDA]
[January 19, 2006 – Protopic Letter – FDA]

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Roche Diagnostics ACCU-CHEK Aviva Meters

Audience: Endocrinologists, Family Practitioners, Pharmacists, other healthcare professionals and consumers
[Posted 01/19/2006] Roche Diagnostics and FDA notified healthcare professionals of a worldwide voluntary recall of specific ACCU-CHEK Aviva Meters, used to measure blood sugar levels, because of the potential for an electronic malfunction which can cause the meter to report an erroneous result or shut down and no longer be used. The recall includes U.S. serial numbers 52500000000 through 52510999999. Only the recalled ACCU-CHEK Aviva Meters have the potential to experience the electronic malfunction.

This recall does not apply to meters with U.S. serial numbers 52511000000 and higher or ACCU-CHEK Aviva test strips. Individuals who have ACCU-CHEK Aviva Meters with the referenced serial numbers should contact 1-888-591-5084 for a product replacement.

[January 16, 2006 – Recall Notice – FDA]

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Brazilian Diet Pills (Emagrece Sim and Herbathin products)

Audience: Consumers and all healthcare professionals
[Posted 01/13/2006] The FDA warned consumers not to use two unapproved drug products that are being marketed as dietary supplements for weight loss. Emagrece Sim Dietary Supplement, also known as the Brazilian Diet Pill, and Herbathin Dietary Supplement may contain several active ingredients, including controlled substances, found in prescription drugs that could lead to serious side effects or injury. They contain chlordiazepoxide HCl (the active ingredient in Librium), and fluoxetine HCl (the active ingredient in Prozac). Emagrece Sim and Herbathin were also found to contain Fenproporex, a stimulant that is not approved for marketing in the United States. Consumers are advised not to use the Emagrece Sim and Herbathin products and to return them to the suppliers. There may be other manufacturers or suppliers of imported Emagrece Sim and Herbathin, and consumers should exercise caution in using any of these imported products.

[January 13, 2006 - News Release - FDA]

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Clozaril (clozapine) tablets

Audience: Neuropsychiatric healthcare professionals and patients
[Posted 01/13/2006] Novartis and FDA notified healthcare professionals of revisions to the BOXED WARNING, WARNINGS, CONTRAINDICATIONS, PRECAUTIONS (Information for Patients and Pharmacokinetic-Related Interactions subsections), and ADVERSE REACTIONS (Postmarketing Clinical Experience subsection) sections of the prescribing information for Clozaril (clozapine) tablets. Recommendations from the FDA's Psychopharmacological Drugs Advisory Committee regarding the white blood cell monitoring schedule, required for all clozapine users, has resulted in modification in the monitoring schedule. Additional labeling changes address safety issues related to dementia-related psychosis, parlytic ileus, hypercholesterolemia and pharmacokinetic interaction with citalopram.

[December, 2005 - Letter with attachments - Novartis]
[May, 2005 - Label - Novartis]

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Ortho VITROS Immunodiagnostic HBsAg Confirmatory Kit

Audience: Clinical laboratory personnel
[Posted 01/09/2006] Ortho-Clinical Diagnostics and FDA notified healthcare professionals and clincal laboratory staff of a class 1 recall of the HBsAg Confirmatory Kit due to an unknown component in the diluting solution used to test blood and serum samples that may produce 'Not Confirmed' results for samples found to be positive with the initial test. This can cause some results to be classified as false negatives. False negative results may prevent some patients infected with or carrying the hepatitis B virus from receiving necessary treatment. This is especially true for pregnant women whose tests show false negative results. The company recommends that previously reported results be reviewed.

[January 09, 2005 - Recall Notice - FDA]

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WinRho SDF (Rho(D) Immune Globulin Intravenous [Human])

Audience: Hematologists and other healthcare professionals
[Posted 01/06/2006] Cangene, Baxter Healthcare and FDA notified healthcare professionals of revisions to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the prescribing information for WinRho SDF (Rho(D) Immune Globulin Intravenous [Human]) to address two important safety concerns.

1] Continued postmarketing safety surveillance has shown rare, but severe and sometimes fatal, intravascular hemolysis and potentially serious complications, including disseminated intravascular coagulation in patients with ITP. Physicians should discuss the risks and benefits of WinRho SDF, alert patients who are being treated for ITP about the signs and symptoms associated with intravascular hemolysis (back pain, shaking chills, fever, discolored urine, decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath) and advise patients to report any symptoms immediately to their physicians.

2] Maltose in IVIG products, such as the liquid formulation of WinRho SDF, has been shown to give falsely high blood glucose levels in certain types of blood glucose testing systems. Due to the potential for falsely elevated glucose readings, only testing systems that are glucose-specific should be used to test or monitor blood glucose levels in patients receiving this product.

[December 09, 2005 - Dear Healthcare Professional Letter - Cangene/Baxter Healthcare]
[December 2005 - Label - Cangene/Baxter Healthcare]
[December 2005 - Patient Information - Cangene/Baxter Healthcare]

Previous FDA/MedWatch alerts
[November 09, 2005 - Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products ]
[November 09, 2005 - Important Safety Information - FDA/CBER]

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Avandia (rosiglitazone maleate)
Avandamet (rosiglitazone maleate/metformin HCl)

Audience: Endocrinologists, other healthcare professionals and patients
[Posted 01/05/2006] GlaxoSmithKline and FDA notified healthcare professionals about post-marketing reports of new onset and worsening diabetic macular edema for patients receiving rosiglitazone. In the majority of these cases, the patients also reported concurrent peripheral edema. In some cases, the macular edema resolved or improved following discontinuation of therapy and in one case, macular edema resolved after dose reduction.

[December 2005 - Letter - GlaxoSmithKline]

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FDA/CDER/OCD/Safety Policy and Communication Staff
Web page last revised by jw April 12, 2007