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
(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:
Return to Quick Reference
Dietary Supplements:
5-hydroxy-L-tryptophan (Posted 9/1/98)
Cholestin (Posted: 5/26/98)
"Sleeping Buddha" (Posted: 3/10/98)
Return to Quick Reference
Drugs:
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)
Return to Quick Reference
Medical Devices:
Return to Quick Reference
Other Products:
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
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- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
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- 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]
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- 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]
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- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
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- 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]
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- 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]
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- 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 ]
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- 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]
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- 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]
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- 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]
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- 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]
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- 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]
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- 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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