New Safety Information Summaries
1998

Summaries of "Dear Health Professional" letters and other safety notifications of which MedWatch is aware. Listed in reverse chronological order.

Current as of: January 20, 1999

Quick Reference:

(Click on the type of medical product to go directly to those products and then click on the product of interest to go to the summary for that product.)

NOTE: These summaries do not include all of the information contained in the letter or other notification; therefore, to see the full text, click on the underlined type of notification at the end of each summary.

Biologics - Dietary Supplements - Drugs - Medical Devices - Other

Abbokinase (urokinase) (Posted: 12/15/98)
Albumin/Plasma Protein Fraction (Posted: 8/26/98)
Blood Products/Hepatitis C Testing (Posted: 10/19/98)
Immune Globulin Intravenous (Human) (Posted: 11/13/98)
Infliximab (Posted: 11/25/98)
Rituxan (rituximab) (Posted: 12/8/98)

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5-hydroxy-L-tryptophan (Posted 9/1/98)
Cholestin (Posted: 5/26/98)
"Sleeping Buddha" (Posted: 3/10/98)

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Accutane (isotretinoin) (Posted: 2/25/98)
Carnitine (levocarnitine) (Posted: 1/13/99)
Claritin-D 24 Hour (loratadine/pseudoephedrine) (Posted: 12/11/98)
Duract (bromfenac Na) (Posted: 2/9/98)
Duract (bromfenac Na) - withdrawal (Posted: 6/22/98)
Epipen & Epipen Jr. (epinephrine) (Posted: 5/8/98)
Evista/E-Vista (raloxifene HCl)/(hydroxyzine HCl) (Posted: 6/9/98)
Gentamicin Sulfate ( Posted: 12/8/98) Hismanal (astemizole) (Posted: 2/9/98)
Inhaled Products (intranasally & orally) (Posted:11/10/98)
Lamictal/Lamisil (lamotrigine)/(terbinafine HCl) (Posted:6/15/98)
Low Molecular Weight Heparins & Heparinoids (Updated: 5/7/98)
Modudose Sodium Chloride Solution (Posted: 4/29/98)
Norvir (ritonavir) (Posted: 7/28/98)
OTC Pain Relievers & Fever Reducers (Posted: 10/21/98)
Posicor (mibefradil dihydrochloride) - withdrawal (Posted: 6/8/98, Updated: 6/12/98)
Propulsid (cisapride) (Posted: 6/29/98)
Rezulin (troglitazone) (Posted: 7/28/98)
Seldane and Generic (Posted: 3/2/98)
Singulair (montelukast Na) (Posted: 12/4/98)
Soriatane/Loxitane (acitretin)/(loxapine succinate) (Posted: 7/7/98)
Tasmar (tolcapone) (Posted: 11/17/98)
Tegretol (carbamazepine) (Posted: 3/20/98)
Thalidomide (Posted: 7/16/98)
Ticlid (ticlopidine HCl) (Posted: 8/11/98)
Viagra (sildenafil citrate) (Posted: 5/22/98)
Viagra (sildenafil citrate) - death reports (Posted: 6/8/98, Updated: 7/21/98, 8/24/98, 11/24/98)
Viagra (sildenafil citrate) (Posted: 11/24/98)
Vistide (cidofovir) Posted: 8/21/98)

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Abtox Plazlyte Sterilization System (Posted: 4/3/98 - Talk Paper, 4/15/98 - Safety Alert)
Bjork-Shiley 60 Degree Convexo-Concave Heart Valves (Posted: 4/14/98; UPDATED 2/15/2005)
Chlorhexidine-Impregnated Medical Devices (Posted: 3/16/98)
Cobe Centrysystem 3 Blood Tubing Sets (Posted: 5/26/98, Updated: 6/10/98)
Contact Lenses (Posted: 10/6/98)
Electrical Weight Loss Pad (Posted: 7/6/98)
Hemodialysis Catheter Adapter (Posted: 3/30/98)
Implantable Medical Devices & Metal Detector Systems (Posted: 10/7/98)
Isocam II (dual-headed gamma camera) (Posted: 2/17/98, Updated: 3/12/98)
Lead Wires and Patient Cables (Posted: 10/5/98)
Medical Device Computer Date Problems (Posted: 12/29/98)
Medical Telemetry Systems (Posted: 3/26/98)
Pacemakers (Posted: 10/14/98)
Sox Coronary Stent System (Posted: 10/9/98, Letter added: 10/13/98)
Surestep Blood Glucose Meters (Posted: 6/8/98, Updated: 7/28/98)
Tampons (Posted: 1/20/99)
Vacuum Assisted Delivery Devices (Posted: 5/20/98)

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Indian Healing Clay (Posted: 5/11/98)

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Medical Device Computer Date Problems

FDA warns hospitals, emergency medical services and health care practitioners that the kind of computer date bugs expected to produce problems on January 1, 2000 will affect some medical devices a year early in 1999.
[December 29, 1998 ( Advisory) - FDA]

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Tampons

FDA regulates the safety and effectiveness of medical devices, including tampons. Recently it has come to the agency's attention that allegations about tampons are being spread over the Internet. It is alleged that some tampons are contaminated by asbestos and dioxin, and that rayon fibers cause toxic shock syndrome (TSS). There is no evidence supporting any of these rumors. Their source is unknown. FDA provides information that will help answer concerns.
[December 21, 1998 ( Text, PDF) - FDA]

Abbokinase (urokinase)

FDA clarifies that the FDA Center for Biologics Evaluation and Research (CBER) will not release lots of Abbokinase until CBER's review of the inspectional findings and information recently submitted by Abbott is complete. During inspections of Abbott, FDA observed significant deviations from Current Good Manufacturing Practices. The lot release mechanism is one of the methods used by FDA to ensure that biological products are safe and have been manufactured in accordance with laws and regulations.
[December 11, 1998 (Information Sheet) - FDA]

Claritin-D 24 Hour (loratidine/pseudoephedrine)

The company notifies health professionals of the introduction of a new oval-shaped Claritin-D 24 Hour tablet because the current round-shaped tablet has been associated with postmarketing reports of mechanical upper gastrointestinal tract and esophageal/pharyngeal obstruction.
[December 7, 1998 (Letter) - Schering]

Rituxan (ritiximab)

The company notifies health professionals of labeling changes based on postmarketing reports of severe infusion-related adverse events that resulted in fatal outcomes.
[December 5, 1998 (Letter) - Genentech & IDEC Pharmaceuticals]

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Singulair (montelukast Na)

The company notifies health professionals of labeling changes based on postmarketing case reports in which patients who were receiving Singulair presented with eosinophilic conditions sometimes consistent with the Churg-Strauss syndrome (CSS).
[December 4, 1998 (Letter) - Merck]

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Gentamicin Sulfate

American Pharmaceutical Partners, Inc. is voluntarily withdrawing all unexpired 40mg/mL lots of the Gentamicin Sulfate Injection, USP. These lots were manufactured by Fujisawa USA, Inc. and by American Pharmaceutical Partners, Inc. and distributed under the Fujisawa Inc. label. The reason for this voluntary withdrawal is an increase in the frequency of reports of adverse reactions to the 40 mg/mL products. The vast majority of reported reactions, where dosing information is available, have been associated with the administration of once-daily dosages of the product. Accordingly, the company does not recommend the once-daily dosing of this product.
[November 30, 1998 (Letter) - American Pharmaceutical Partners]

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Viagra (sildenafil)

FDA and Pfizer, Inc. advise health professionals about new and expanded safety information in the labeling for Viagra (sildenafil citrate). These revisions reflect safety information obtained through postmarketing experience as well as a reemphasis and clarification of information that was already included in the insert.
[November 24, 1998 ( Talk Paper) - FDA]
[November 24, 1998 (Important Prescribing Information) - Pfizer]
[November 24, 1998 (Revised Viagra Labeling) - Pfizer]
[November 24, 1998 (Postmarketing Safety Update) - FDA]

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Tasmar (tolcapone)

The company advises of new warnings in the labeling for Tasmar (tolcapone), a COMT inhibitor indicated as an adjunct to levodopa and carbidopa for the treatment of Parkinson's disease. These new warnings pertain to reports of severe, potentially life-threatening cases of severe hepatocellular injury.
[November 16, 1998 ( Letter) - Roche]

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Immune Globulin Intravenous (Human) - IGIV - Products

FDA alerts physicians to safety precautions that should be taken to reduce the potential risk of Acute Renal Failure (ARF) associated with the administration of Immune Globulin Intravenous (Human) (IGIV) products.
[November 13, 1998 ( Letter) - FDA]

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Infliximab

Centor advises physicians that caution should be exercised when retreating patients with infliximab following an extended period without treatment. The company reports a change in the time to onset of previously reported serious adverse events that have occurred in a clinical trial in which patients with moderately to severely active Crohn's disease and fistulizing Crohn's disease were retreated with infliximab two to four years following their initial infliximab treatment.
[November 10, 1998 ( Letter) - Centocor]

Intranasally & Orally Inhaled Products

FDA informs companies of new pediatric information that will be required on the labeling of all orally inhaled and intranasal corticosteroids. The new labeling language will alert health care providers that using these drugs in children may reduce their rate of growth. It will also recommend using the lowest effective dose of these drugs and routinely monitoring patients' growth rates.
[November 9, 1998 ( Talk Paper) - FDA]
[November, 1998 (Class Labelling - FDA]

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OTC Pain Relievers & Fever Reducers

FDA announces that all over-the-counter (OTC) pain relievers and fever reducers must carry a warning label advising people who consume three or more alcoholic drinks every day to consult their doctors before using these drugs.
[October 21, 1998 ( HHS News) - FDA]
[October 23, 1998 (Federal Register:Final Rule - FDA]

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Blood Products/Hepatitis C Testing

CDC recommends that all patients be tested for hepatitis C if they are notified that they received blood that possibly contained hepatitis C virus (HCV) or if they received blood before July 1992.
[October 2, 1998 ( More Information) - CDC]
[October 16, 1998 (MMWR) - CDC (NOTE: 2 hours of free CME credit available with this article)]
[Related Information - August 23, 1998 (Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV PDF Version, Text Version) - FDA]
[November 3, 1998 (Letter from Surgeon General) - HHS]

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Minute Ventilation Rate-Adaptive Pacemakers

FDA alerts health professionals that minute ventilation rate-adaptive implantable pacemakers can occasionally interact with certain cardiac monitoring and diagnostic equipment, causing pacemakers to pace at their macimum programmed rate.
[October 14, 1998 (Letter ) - FDA]

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Sox Coronary Stent System

Boston Scientific Corporation, headquartered in Natick, Mass., announced on October 5 that it has stopped distributing its NIR ON Ranger with Sox coronary stent delivery system and is voluntarily withdrawing the product from the market due to a serious risk of patient injury. The Sox system is one of two delivery systems marketed for the stent. The FDA considers the withdrawal to be a total product recall. FDA urges hospitals to immediately stop using this device because of potential risk to patients.
[October 8, 1998 (HHS News ) - FDA]
[October 8, 1998 (Letter) - FDA]

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Anti-Theft and Metal Detector Systems and Pacemakers, ICDs, and Spinal Cord Stimulators

FDA notifies health professionals that the operation of certain medical devices, including pacemakers, implantable cardioverter/defibrillators and spinal cord stimulators, may be affected by the electromagnetic fields produced by anti-theft systems and metal detectors; and provides information and recommendations to help patients prevent or minimize any adverse effects.
[September 28, 1998 (Important Information) - FDA]

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Illegal Promotion of Contact Lenses

FDA notifies health eyecare practitioners, contact lens dispensers and contact lens wearers of two illegal and potentially unsafe practices on the part of some contact lens companies.
[September 25, 1998 (Public Health Notification) - PDF format - FDA]

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5-hydroxy-L-tryptophan

FDA scientists have confirmed the presence of impurities in some 5-hydroxy-L-tryptophan (5HTP) products currently marketed and widely promoted as dietary supplements. These products are being used as aids for insomnia, depression, obesity, and in children with attention deficit disorder. FDA's analytical results are consistent with those obtained and published by researchers from the Mayo Clinic.
[August 31, 1998 (Talk Paper) - FDA]

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Albumin/Plasma Protein Fraction

The Food and Drug Administration alerts health professionals to a recent review and commentary which calls into question the medical benefit of administration of albumin or plasma protein fraction (PPF) to seriously ill patients. [August 19, 1998 (Letter) - FDA]

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Lead Wires and Patient Cables

The Food and Drug Administration alerts Administrators and Risk Managers that beginning January 1, 1999, only electrode lead wires and patients cables that are protected may be used with the following devices: breathing frequency monitors; ventilatory effort monitors (apnea detectors); electrocardiographs (ECGs); radiofrequency physiological signal transmitters and receivers; cardiac monitors; electrocardiograph electrodes (including pre-wired ECG electrodes); patient transducer and electrode cables (including connectors); medical magnetic tape recorders (e.g., Holter monitors); arrythmia detectors and alarms; and telephone electrocardiograph transmitters and receivers.
[August 3, 1998 (Public Health Message) - FDA]

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Vistide (cidofovir)

After continuing to receive reports of renal failure associated with Vistide use, the manufacturer reminds health professionals of the importance of adherence to specific treatment guidelines when administering Vistide. Additionally, providers are alerted to recent reports of anterior uveitis or iritis and hearing loss in patients receiving therapy with Vistide.
[August 1998 (Letter) - Gilead]

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Ticlid (ticlopidine HCl)

Roche notifies health professionals about important changes to the labeling of Ticlid (ticlopidine HCl). These changes will more prominently describe an adverse reaction to Ticlid, thrombotic thrombocytopenic purpura (TTP), a condition that is potentially life-threatening, and give information about its diagnosis and treatment.
[August 1998 (Letter) - Roche]

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Norvir (ritonavir)

Abbott informs healthcare professionals about manufacturing difficulties with the capsule formulation of their HIV protease inhibitor, Norvir, which will result in a shortage of capsules. The company has encountered an undesired formation of a Norvir crystalline structure that affects how the capsule form of Norvir dissolves. Their plan is to supply Norvir oral solution (liquid) to provide continued Norvir therapy for patients.
[July 28, 1998 (Health Professional Letter) - Abbott]
[July 28, 1998 (Consumer Letter) - Abbott]

Rezulin (troglitazone)

Parke-Davis informs healthcare professionals about the modified requirements relating to more stringent liver enzyme monitoring as reflected in the new product labeling for Rezulin. These new liver enzyme monitoring modifications are intended to reduce the risk of rare but serious liver injury, including liver failure leading to transplant or death.
[July 28, 1998 (Letter) - Parke-Davis]

Carnitine (levocarnitine)

The company notifies healthcare professionals of labeling changes regarding the occurrence of seizures in some patients receiving Carnitor.
[July 23, 1998 (Letter) - Sigma Tau]

Thalomid (thalidomide)

FDA announces that Thalomid (thalidomide) has been approved for marketing as a treatment for erythema nodosum leprosum (ENL), a serious inflammatory condition in patients with Hansen's disease (also known as leprosy). To prevent fetal exposure to the drug, a restricted distribution program, the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) will be utilized.
[July 16, 1998 (Thalidomide Information) - FDA]

Soriatane/Loxitane (acitretin)/(loxapine succinate)

FDA notifies health professionals of numerous reports of name confusion between Soriatane (acitretin) and Loxitane (loxapine succinate).
[July 7, 1998 (Prescribing Notice) - FDA]

Electrical Weight Loss Pad

FDA alerts consumers to a nationwide recall of an electrical weight loss pad initiated by TV Store Corp./Body Fitness Inc., a company based in Miami, Fla., which markets its products on television. The firm has received complaints that indicate that its Moulding Body Electrical Body Belts, also called the Personal Electro-Sauna, is hazardous and has caused skin burns and fires. The product resembles a heating pad and can be wrapped around the waist, thighs or arms. It is not approved by the FDA.
[July 2, 1998 (HHS News - English) - FDA]
[July 2, 1998 (HHS News - Spanish) - FDA]

Propulsid (cisapride)

FDA advises doctors about new warnings of cardiac problems associated with the drug Propulsid (cisapride), a treatment for nighttime heartburn. FDA's warning was issued in conjunction with a "Dear Healthcare Professionals letter" from Janssen Pharmaceutica. The drug's labeling has been revised to include new information about the cardiac risks associated with the drug and to recommend that other therapies for heartburn generally be used before Propulsid. These actions were prompted by reports of serious adverse reactions -- including heart rhythm disorders and deaths associated mostly with the use of the drug in people who were taking certain other medications or who had particular underlying medical conditions.
[June 26, 1998 (Letter) - Janssen]
[June 29, 1998 (Talk Paper) - FDA]

Duract (bromfenac sodium)

Wyeth-Ayerst announces the voluntary market withdrawal of the nonsteroidal anti-inflammatory analgesic Duract. This action is based on postmarketing reports of severe hepatic failure resulting in four deaths and eight liver transplants. All but one of those 12 cases involved the use of Duract for longer then 10 days - - the maximum recommended duration of treatment. The exception involved a patient with pre-existing significant liver disease.
[June 22, 1998 (Letter) - Wyeth-Ayerst]
[June 22, 1998 (Press Release) - Wyeth-Ayerst]
[June 22, 1998 (Talk Paper) - FDA]
[June 22, 1998 (Questions & Answers) - FDA]

Lamictal/Lamisil (lamotrigine)/(terbinafine HCl)

Glaxo Wellcome notifies health professionals of reports of prescription dispensing errors involving the antiepileptic drug LAMICTAL (lamotrigine) and the antifungal drug LAMISIL (terbinafine hydrochloride). These reports involve dispensing Lamictal when Lamisil was prescribed and the reverse scenario.
[June 1998 (Letter) - GlaxoWellcome]

Evista/E-Vista (raloxifene HCl)/(hydroxyzine HCl)

FDA notifies health professionals of numerous reports of name confusion between Evista (raloxifene HCl) and E-Vista (hydroxyzine HCl).
[June 9, 1998 (Prescribing Notice) - FDA]

Viagra (sildenafil citrate)

In response to Freedom of Information Requests, FDA has posted synopses of the fatal outcome reports submitted to the FDA as of June 8, 1998 (updated: 7/21/98, 8/24/98) in which Viagra was a listed, associated drug.
[June 8, 1998 (Update: 7/21/98, 8/24/98) ( Postmarketing Information)- FDA]

Posicor (mibefradil dihydrochloride)

Roche Laborabories announces the immediate voluntary market withdrawal of the antihypertensive and anti-anginal medication, Posicor (mibefradil dihydrochloride). The action is based on evolving information concerning the potential for drug interactions, some of them serious, that may occur when Posicor is taken together with some other medications. Roche also provides important information on drug interactions and therapy substitution when patients are taken off Posicor.
[June 12, 1998 ( Therapy Substitution Letter) - Roche]
[June 8, 1998 ( Letter) - Roche]
[June 8, 1998 ( News Release) - Roche]
[June 8, 1998 ( Talk Paper)- FDA]

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Surestep Blood Glucose Meters

Lifescan announces removal and replacement of certain Surestep consumer blood glucose meters because meters made before August 1997 may give an "ER 1" (Error 1) message if a patient's blood glucose (sugar) is very high - 500 mg/dL or greater. Failure to recognize a seriously high blood glucose level could cause serious health consequences, including hospitalization and death. A recall of meters manufactured before August 1997 has been initiated.
[July 28, 1998 (HHS News) - FDA]
[June 4, 1998 ( News Release - LifeScan]

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Cobe Centrysystem 3 Blood Tubing Sets

Gambro Healthcare announces the immediate and urgent recall of COBE Centrysysten 3 Blood Tubing sets with the Part Number 003210-500 and Lot Numbers of 04D15308, 04D15309, and 04D15310. On June 10, 1998 the recall was expanded to include ALL lots, including Hemodialysis Kits containing blood tubing sets with catalog numbers 003109-400, 003109-410, 003110-500, 003111-500, 003112-500, 003113-500, 003114-500, 003210-500, 003212-500, 003101-000, and 003212-515.
[May 25, 1998 ( Press Release) - Gambro Healthcare]
[June 10, 1998 ( Expanded Recall Press Release) - Gambro Healthcare]

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Viagra (sildenafil citrate)

Pfizer reminds health professionals of the contraindication between Viagra and the concomitant administration of an organic nitrate.
[May 22, 1998 ( Letter) - Pfizer]

Vacuum Assisted Delivery Devices

FDA advises that vacuum assisted delivery devices may cause serious or fatal complications and provides guidance to minimize the risk.
[May 21, 1998 ( Public Health Advisory) - FDA]

Cholestin

FDA determines Cholestin, marketed as a dietary supplement, to be an unapproved drug. Cholestin contains lovastatin, an active ingredient in the approved prescription drug Mevacor used to lower cholesterol levels.
[May 20, 1998 (Talk Paper) - FDA]

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Indian Healing Clay

FDA has been notified of a case of neonatal tetanus associated with the use of a cosmetic facial clay as a dressing on an umbilical cord stump. The product "Indian Healing Clay" is marketed by Aztec Beauty Products as a facial mask.
[May, 1998 ( Notice) - FDA]

Epipen & Epipen Jr. (epinephrine) Auto-Injectors

Meridian Medical Technologies Inc. has voluntarily recalled 47 lots of Epipen and Epipen Jr. because some may not provide effective doses of medication to treat acute allergic emergencies (anaphylaxis). The affected product was distributed in the US by Dey Laboratories between July 1997 and April 1998. The packaging indicates that the product was manufactured for Center Laboratories or Dey Laboratories by Survival Technology Inc. or Meridian Medical Technologies.
[May 8, 1998 ( Press Release) - Meridian ]

Low Molecular Weight Heparins & Heparinoids

In December 1997, FDA advised doctors to carefully monitor patients receiving low molecular weight heparins or heparinoids (marketed as Lovenox, Fragmin, Normiflo, and Orgaran). These drugs when used concurrently with spinal or epidural anesthesia, or spinal puncture may cause bleeding or hematomas within the spinal column. Increased pressure on the spinal cord may result in permanent paralysis if not detected and treated immediately.
[December 15, 1997 ( Talk Paper) - FDA]
[December 15, 1997 ( Public Health Advisory) - FDA]
[February 5, 1998 ( Advisory Committee Transcript) - FDA (300 pages)]
[May 6, 1998 (Questions & Answers -FDA]

Modudose Sodium Chloride Solution

Various brands of Modudose Sodium Chloride Solution have been recalled based on the findings of two lots of this product (714430 & 718315) containing the bacteria Ralstonia pickettii (formerly Burkholderia picketti, formerly Pseudomonas pickettii). While no injuries have been reported as a direct result of this contamination, Ralstonia picketti has been associated with sepsis and could be life-threatening to people with lung disease or certain immunocompromised patients.
[April 29, 1998 ( Recall Notice)- FDA]
[April 17, 1998 (MMWR Article - CDC]

Abtox Plazlyte Sterilization System

FDA warns hospitals and physicians against the use of the Abtox Plazlyte Sterilization System, because FDA is aware of at least 10 injuries associated with ophthalmic surgical instruments which had been sterilized with this system. These reports involved serious injuries to the cornea with damage to vision, and at least two cases have required corneal transplantation.
[April 2, 1998 ( Talk Paper)- FDA]
[April 13, 1998 ( Safety Alert)- FDA]
[April 24, 1998 (MMWR Article - CDC]

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Hemodialysis Catheter Adapter

FDA warns that the Extension Adapter for a Tesio hemodialysis catheter made or distributed by Medcomp, Harleysville, PA, may come apart, causing the patients on chronic hemodiaylsis to bleed to death at home.
[March, 1998 ( HHS News)- FDA]

Medical Telemetry Systems

FDA alerts the health community of incidents involving digital television (DTV) transmissions interfering with medical telemetry systems that use TV channels.
[March 20, 1998 ( Public Health Advisory)- FDA]
[March 25, 1998 ( Joint Statement)- FDA & FCC]

Tegretol (carbamazepine)

Novartis informs health care professionals that Tegretol Suspension should not be administered simultaneously with other liquid medicinal agents or diluents.
[March, 1998 ( Letter)- Novartis]

Chlorhexidine-Impregnated Medical Devices

FDA informs health care professionals about the potential for serious hypersensitivity reactions to chlorhexidine-impregnated medical devices.
[March 11, 1998 ( Public Health Notice)- FDA]

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"Sleeping Buddha"

FDA is warning consumers not use a product called "Sleeping Buddha". It is marketed as a dietary supplement but has been determined to contain the prescription-strength drug ingredient estazolam. Estazolam is known to have serious side effects, including the potential to cause fetal damage if a pregnant woman consumes the drug.
[March 10, 1998 ( Statement)- FDA]

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Seldane and Generic Terfenadine

Hoescht Marion Roussel and Baker Norton Pharmaceuticals have voluntarily discontinued distribution and marketing of all terfenadine-containing antihistamine product lines in the United States. these products will soon disappear from pharmacies as existing supplies are depleted.
[February 27, 1998 ( Talk Paper)- FDA]

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Accutane (isotretinoin)

Roche advises that the lableing for Accutane has been changed to add information in the WARNINGS and ADVERSE REACTIONS section about reported cases of depression, psychosis, and, rarely suicide ideation, suicide attempts and suicide associated with the use of Accutane. No mechanism of action has been established.
[February 1998 ( Letter)- Roche]
[February 25, 1998 ( Talk Paper)- FDA]

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Isocam II (Dual-Headed Gamma Camera)

FDA notifies Nuclear Medicine Imaging Facilities of a recent incident where an Isocam II, dual-headed nuclear medicine gamma camera malfunctioned. A stainless steel plate from a harmonic drive motor failed, causing an arm of the system to fall into the gantry housing of the device. While no patient or operator was injured, a potential for serious injury exists from such a malfunction.
[February 13, 1998 ( Safety Notice) - FDA]
[March 12, 1998 ( Supplemental Information) - FDA]

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Duract (bromfenac Na)

Wyeth-Ayerst has revised the Duract labeling to include a Boxed Warning about severe hepatic reactions, including jaundice, potentially fatal fulminant hepatitis and liver failure (some requiring transplantation) that have occurred in patients taking Duract for longer than the recommended duration.
[February 1998 ( Letter) - Wyeth-Ayerst]
[February 10, 1998 (Talk Paper) - FDA]

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Hismanal (astemizole)

Janssen Pharmaceuticals notifies healh professionals of important labeling changes concerning new Contraindications, Warnings, Precautions, Adverse Events, and additional drug or food Interactions with Hismanal.
[February 1998 ( Letter) - Janssen]
[February 9, 1998 (Talk Paper - FDA]

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Bjork-Shiley 60 Degree Convexo-Concave Heart Valves

The Bowling-Pfizer Settlement provides new information about the risk of outlet strut fracture for 60 degree Bjork-Shiley Convexo-Concave (BSCC) heart valves and new recommendations from an independent expert panel regarding prophylactic valve replacement.

UPDATE:
[November 2003 (Letter) - Bowling-Pfizer]
[July 2003 (Amended Guidelines To Assess Patients With Bjork-Shiley Convexo-Concave HeartValves) - Bowling-Pfizer]

[January 1998 ( Letter) - Bowling-Pfizer Settlement]

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