Safety Information Summaries
1999

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

Current as of: October 13, 2000

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: 1/26/99, Updated: 3/16/99, Updated: 3/22/99, Updated: 7/19/99)
Enbrel (etanercept) (Posted: 5/12/99)
EZ MedTest (rapid home-use HIV text kit) (Posted: 7/9/99
Herceptin (trastuzumab) (Posted: 10/15/99)
Human Albumin (Posted: 3/5/99)
Immune Globulin (Posted: 3/5/99)
Immune Globulin (Posted: 6/25/99)
Immune Globulin Intravenous (Posted: 7/2/99)
Immune Globulin Intravenous (Posted: 6/11/99)
Immune Globulin Intravenous (Posted: 9/30/99)
Plas+ SD (pooled plasma, solvent detergent treated) (Posted: 4/19/99, Updated: 5/4/99, 5/14/99)
Rotavirus Vaccine (Posted: 7/19/99, Updated: 10/15/99)
Thimerosal in Vaccines(mercury) (Posted: 7/9/99)
Tripedia (diphtheria/tetanus toxoids/acellular pertussis vaccine adsorbed) (Posted: 1/28/99)

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Dietary Supplements:

Asian Remedy for Menstrual Cramps - Koo Sar (Posted: 1/25/99)
Gamma Butyrolactone (GBL) (Posted: 1/22/99)
GBL-Related Products (Posted: 5/11/99)
GBL, Gamma Hydroxybutyric Acid (GHB) and 1,4 Butanediol (BD) (Posted: 8/25/99)

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Albuterol (Posted: 9/10/99)
Celebrex (celecoxib) (Posted: 5/28/99)
Cerebyx (fosphenytoin Na) (Posted: 1/28/99)
Cylert (pemoline) (Posted: 6/18/99)
Epinephrine Injection (Posted:9/7/99)
Eulexin (flutamide) (Posted: 9/27/99)
Erythromycin (Posted: 12/22/99)
Flovent (fluticasone propionate) (Posted: 1/21/99)
Gentamicin Sulfate (Posted: 7/29/99)
Hismanal (astemizole) (Posted: 6/21/99)
Methotrexate (methotrexate sodium) (Received & Posted: 11/29/99)
Mirapex (pramipexole dihydrochloride) (Posted: 9/21/99)
Orap (pimozide) (Posted: 9/27/99)
Penicllin G Sodium (Updated: 10/13/00; Posted: 12/20/99)
Propulsid (cisapride) (Posted: 6/9/99)
Raxar (grepafloxacin)(Posted: 10/27/99)
Rezulin (troglitazone) (Posted: 6/17/99)
Streptase (streptokinase) (Posted: 12/20/99)
Trovan (alatrofloxacin mesylate) (Posted: 1/28/99)
Trovan (trovafloxacin/alatrofloxacin mesylate) (Posted: 6/9/99)
Vanceril (beclomethasone dipropionate)(Posted: 12/03/99)
Videx (didanosine, ddI)(Posted: 11/19/99)
Viramune (nevirapine)(Posted: 11/12/99)
Xeloda (capecitabine) (Posted: 4/30/99)
Xenical/Xeloda (orlistat/capecitabine) (Posted: 8/27/99)

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Vascular Hemostasis Devices (Posted: 10/13/99)
Bedside Leukocyte Reduction Filters (Posted: 5/6/99)
Bronchoscopies (Posted: 7/13/99)
Endoscope Reprocessing System (Posted: 9/13/99)
Glass Capillary Tubes (Posted: 2/22/99)
Hemodialysis Treatment (Posted: 5/11/99)
Life Support Products Oxygen Regulators (Posted: 2/4/99)
Philips Medical SD800 Diagnostic Ultrasound System (Hewlett-Packard) (Posted: 3/26/99)
Tampons (Posted: 2/25/99 as an update to 12/21/98 statement)
Y2K Biomedical Equipment Clearinghouse (Posted: 1/13/99, Updated: 3/5/99)

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Other Products:

DawnMist Mouth Rinse (Posted: 4/29/99, Updated 3/27/2002)

Erythromycin

Health professionals are notified of 7 cases of infantile hypertrophic pyloric stenosis. All seven cases were born in the same hospital and given erythromycin orally for prophylaxis following possible exposure to pertussis, although none had pertussis diagnosed.
[December 17, 1999 (MMWR) - CDC]

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Streptase (streptokinase)

Health professionals are notified of serious adverse events associated with the unlabeled use of Streptase to restore patency of intravenous catheters (including central venous catheters).
[December 20, 1999 (Letter) - AstraZeneca]

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Penicillin G Sodium

Health professionals are notified of the status and availability of Penicillin G Sodium
[December 20, 1999 (Notice) - FDA]

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Vanceril 84 mcg DOUBLE STRENGTH (beclomethasone dipropionate)

Health professionals are notified of a recall of five (5) lots of Vanceril 84 mcg DOUBLE STRENGTH (beclomethasone dipropionate) because a number of the canisters in the five lots may not contain active drug. The recall affects lots Nos. 9-DMT-157, 9-DMT-158, 9-DMT-160, 9-DMT-161 and 9-DMT-163, distributed in November 1999
[December 1, 1999 (Patient Letter) - Schering-Plough]
[December 2, 1999 (Press Release) - Schering-Plough]
[December 2, 1999 (Press Release ) PDF Format - Schering-Plough]
[December 8, 1999 (Health Professional Letter) - Schering-Plough]

Methotrexate Sodium

Health professionals are notified of a summary of important new safety information and labeling changes for Methotrexate Sodium.
[June 1999 (Letter) - Wyeth-Ayerst Laboratories]
[June 1999 (Letter PDF Format) - Wyeth-Ayerst Laboratories]

Videx (didanosine, ddI)

Health professionals are notified of a revised warning about fatal and non-fatal pancreatitis in the labeling for Videx.
[November 11, 1999 (Letter) - Bristol-Myers Squibb Company]
[November 11, 1999 (Letter PDF Format ) - Bristol-Myers Squibb Company]

Viramune (nevirapine)

Health professionals are notified of the potential effect that Viramune may have in patients taking chronic methadone maintenance therapy.
[July 30, 1999 (Letter PDF Format ) - Boehringer Ingelheim]
[July 30, 1999 (Letter) - Boehringer Ingelheim]

Raxar (grepafloxacin)

Health professionals are notified of a voluntary withdrawal of Raxar due to a small number of severe cardiovascular events.
[October 27, 1999 (Press Release) - Glaxo Wellcome]
[October 27, 1999 (PDF Format) - Glaxo Wellcome]
[November 1, 1999 (Letter) - Glaxo Wellcome]

Herceptin (trastuzumab)

Health professionals are notified of a clarification of the instructions for reconstituting Herceptin due to reports of errors in the reconstitution of Herceptin.
[September 23, 1999 (Letter) - Genentech, Inc.]
[September 23, 1999 (Letter in PDF Format) ) - Genentech, Inc.]

Vascular Hemostasis Devices

Health professionals are notified of adverse events related to the use of vascular hemostasis devices. These devices provide an alternative to manual compression in achieving hemostasis following percutaneous femoral arterial punctures in patients undergoing diagnosis and treatment for cardiovascular disease. Reported omlications related to these devices include hematoma, retroperitoneal bleed, pseudoaneurysm, late bleeding, and infrequently, death.
[October 8, 1999 (Letter) (PDF Version ) - FDA]

Immune Globulin Intravenous

Health professionals are notified about a potential risk of acute renal failure reported to be associated with administration of Immune Globulin Intravenous (Human)
[September 24, 1999 (Letter) (PDF Version ) - FDA]

Eulexin (flutamide)

Health professionals are notified about recent changes in the product labeling. the changes include a boxed warning of liver toxicity as well as monitoring requirements for hepatic injury.
[September 1999 (Letter) - Schering]

Orap (pimozide)

Health professionals are notified of sudden, unexpected deaths in patients taking high doses (greater than 10 mg) of Orap, possibly due to prolongation of the QT interval predisposing patients to ventricular arrhythmia. Concomitant use of drugs that are inhibitors of CYP 3A is now contraindicated with Orap.
[September 1999 (Letter - Gate Pharmaceuticals]

Mirapex (pramipexole dihydrochloride

Health professionals are advised of the possibility of patients falling asleep while performing daily activities, including operation of motor vehicles, while receiving treatment with Mirapex, a dopamine agonist, indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
[September 1999 (Letter Pharmacia & Upjohn and Boehringer Ingelheim]

Endoscope Reprocessing System

FDA notifies health professionals of several incidents in which patients developed serious infections after being examined with bronchoscopes that apparently were inadequately reprocessed in an automated endoscope reprocessor. Recommendations to help reduce future incidents are provided.
[September 10, 1999 (Public Health Advisory -- PDF Version ) - FDA]

Albuterol Inhaler Aerosol

The company is voluntarily recalling a single lot (9-BBS-525) distributed between late April and early May 1999. This recall is the result of one patient returning an inhaler that did not contain the drug substance.
[September 9, 1999 (Recall Notice - Warrick]

Xenical (orlistat)/Xeloda (capecitabine)

The company notifies health professionals of 2 reports of dispensing errors involving Xenical and Xeloda.
[August 1999 (Letter - Roche]

GBL, gamma hydroxybutyric acid (GHB) and 1,4 butanediol (BD)

FDA has been warning the public about a group of products sold as dietary supplements for bodybuilding, weight loss and sleep inducement which have been determined to pose a significant public health hazard. These products are chemically related to gamma butyrolactone (GBL), gamma hydroxybutyric acid (GHB), and 1,4 butanediol (BD), and can cause dangerously low respiratory rates (intubation may be required), unconsciousness/coma, vomiting, seizures, bradycardia and death.
[August 25, 1999 ( FDA Notification - FDA]

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Epinephrine Injection

Wyeth-Ayerst is voluntarily withdrawing specific lots of Epinephrine Injection due to potential subpotency.
[August 19, 1999 (Recall Notification - Wyeth-Ayerst]
[August 25, 1999 (Recall Notification - Hollister-Stier]

Gentamicin Sulfate Injection,

ESI Lederle is voluntarily withdrawing twenty lots of Gentamicin Sulfate Injection, USP packaged in 40 mg/mL and 80 mg/2mL strengths due to a higher than expected number of adverse events (pyrogenic-like reactions such as fever, chills or dyspnea) that have been reported coincidental with the administration of these lots. All the lots comply fully with product specifications
[July 28, 1999 (FDA Notification - FDA]

RotaShield (Rotavirus Vaccine) Live, Oral, Tetravalent

Wyeth-Lederle, Division of American Home Products, announces the withdrawal of RotaShield Rotavirus Vaccine. The company has evaluated cases of intussusception reported to VAERS as well as preliminary data from the ongoing epidemiological studies conducted by CDC. These data continue to suggest a temporal association between the use of RotaShield and the development of intussusception.
[October 14, 1999 (Letter) - Wyeth-Lederle]
[October 15, 1999 (Notice) - FDA]
[October 22, 1999 (Advisory Committee Recommendation) - CDC]
[November 5, 1999 ( MMWR Article) - CDC]

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RotaShield (tetravalent rhesus-based rotavirus vaccine, RRV-TV)

As of July 7, 1999, fifteen (15) cases of intussusception (a type of bowel obstruction) among children who recently received rotavirus vaccine have been reported to the Vaccine Adverse Event Reporting System (VAERS). An additional eight cases have been identified in the initial phase of an on-going multi-state investigation.
[July 15, 1999 (Press Release) - CDC]
[July 16, 1999 ( MMWR Article) - CDC]

Bronchoscopies

Three clusters of culture-positive bronchosopy specimens were obtained in 1996 and 1998. An investigation identified problems related to using automated reprocessing machines.
[July 9, 1999 ( MMWR Article) - CDC]

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EZ MedTest (HIV rapid home-use test kit)

In a joint investigation conducted by FDA and the Federal Trade Commission, an unapproved HIV rapid home-use test kit promoted on the Internet and sold domestically was tested by FDA and, in some cases, gave false negative results. FDA is notifying consumers who purchased the "EZ MedTest" marketed by Cyberlinx Marketing, Inc. on the Internet that the test results given by the test are unreliable. Kit purchasers are advised to consult with a health professional regarding other available FDA approved tests that detect antibodies to HIV. The "EZ MedTest" website has been removed from the Internet by Cyberlinx Marketing, Inc. and the firm has voluntarily turned over all remaining test kits to FDA's Office of Criminal Investigations. There is an ongoing FDA investigation of the U.S. firm that supplied the test kits to Cyberlinx Marketing, Inc.
[July 9, 1999 (Letter) - FDA]

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Thimerosal in Vaccines: Joint Statement of AAP and the PHS

Thimerosal has been used as an additive to biologics and vaccines since the 1930s because it is very effective in killing bacteria used in several vaccines and in preventing bacterial contamination, particularly in opened multidose containers. Some but not all of the vaccines recommended routinely for children in the United States contain thimerosal. A joint statement by the American Academy of Pediatrics and the Public Health Service.
[July 9, 1999 (MMWR - CDC]

Immune Globulin Intravenous (Human), Venoglobulin-S, 10% solution

Recent studies have shown that the anticomplementary activity (ACA) of Venoglobulin-S, 10% may not remain stable for its labeled dating period of 24 months when stored at 25 degrees C. Alpha Therapeutic Corporation has determined that, as a precautionary measure, lots of Venoglobulin-S, 10% labeled with a storage temperature of "at or below 25 degrees C" should be relabeled with an expiration date of 12 months after manufacture, a change from the current 24 month dating period.
[July 1, 1999 (Recall Notice - FDA]

Immune Globulin Intravenous Therapy

FDA/CDC describe the epidemiology of IGIV-associated renal adverse events (i.e., acute renal failure or insufficiency) in the US and emphasize the importance of reviewing indications for IGIV use and implementing precautions during its administration.
[June 25, 1999 (MMWR article) - FDA/CDC]

Hismanal (astemizole)

Janssen Pharmaceutica notifies health care providers that they are voluntarily discontinuing the manufacturing, distribution and marketing of Hismanal 10 mg tablets. The company is taking this action after careful consideration of the antihistamine class, which includes multiple alternative medications.
[June 21, 1999 (Letter) - Janssen Pharmaceutica]
[June 21, 1999 (Talk Paper)- FDA]

Cylert (pemoline)

Abbott notifies health professionals that the labeling for Cylert has been revised to provide updated recommendations for liver function monitoring and a Patient Information/ Consent Form.
[June 18, 1999 (Letter) - Abbott]
[June 18, 1999 (Patient Information/Consent Form)- Abbott]
[June 18, 1999 (Labeling)- Abbott]

Rezulin (troglitazone)

Based on further evidence of serious and sometimes fatal liver injury, significant new changes are being made to the labeling and recommended uses for Rezulin.
[June 17, 1999 (Letter) - Parke-Davis]
[June 17, 1999 (Label and Patient Information PDF Version)- Parke-Davis]
[June 17, 1999 ( Talk Paper)- FDA]

Immune Globulin Intravenous (Human), Venoglobulin-S, 10% solution

Alpha Therapeutic Corporation is requesting that 2 lots of Immune Globulin Intravenous (Human), Venoglobulin-S, 10% solution, be held in quarantine until further notice. This action is being taken because post-manufacturing visual inspection detected microbial contamination in a single vial from two other lots of Immune Globuin Intravenous.
[June 11, 1999 (Recall Notice) - FDA]

Trovan (trovafloxacin/alatrofloxacin)

Based on new safety data related to serious liver injury, the FDA advises physicians that the drug Trovan should be reserved for use ONLY in the treatment of patients who meet all of certain specified treatment criteria.
[June 9, 1999 (Public Health Advisory) - FDA]
[June 9, 1999 (Q's & A's) - FDA]
[June 9, 1999 (Talk Paper) - FDA]

Propulsid (cisapride)

Janssen notifies health professionals of two new contraindications (known family history of congenital long QT syndrome and clinically significant bradycardia) and a new drug interaction (coadministration of grapefruit juice with cisapride increases the bioavailablity of cisaparide and concomitant use should be avoided).
[June 1, 1999 (Letter) - Janssen]

Celebrex (celecoxib)

Searle & Pfizer notifies health professionals that in patients receiving Celebrex concurrently with warfarin, there have been infrequent postmarketing reports of increases in prothrombin time, sometimes associated with bleeding events, predominantly in the elderly.
[May 28, 1999 (Letter) - Searle & Pfizer]
[May 28, 1999 (Q's & A's) - FDA]
[May 28, 1999 (Consumer Drug Info Sheet) - FDA]
[May 28, 1999 (Label)]

Enbrel (etanercept)

FDA advises physicians about new safety concerns regarding the use of Enbrel (etanercept), a product recently approved to treat moderate to severe rheumatoid arthritis (RA). New postmarketing reports indicate that certain patients receiving Enbrel have developed serious infections, including sepsis, and that several of these patients have died from their infections.
[May 12, 1999 (Talk Paper) - FDA]
[May 10, 1999 (Letter) - Immunex]

GBL-Related Products

FDA warns the public of a new group of products being marketed as sleep aids that have been associated with at least 3 deaths and several severe adverse reactions. These products are chemically related to gamma butyrolactone (GBL) and gamma hydroxzybutyric acid (GHB) substances that have been determined to pose a significant health hazard to the public.
[May 11, 1999 (Talk Paper) - FDA]

Hemodialysis Treatment

Recent incidents of blood contamination of internal components of hemodialysis equipment at a number of treatment centers have raised concerns about patient safety. The cause of the contamination is still being determined and may include many factors, including faulty blood lines and transducer protectors. FDA will provide updates as to the cause of this problem as soon as proper information becomes available.
[May, 1999 (Safety Alert) - FDA]
[May 7, 1999 (Recall Notice) - Althin Medical]

Hypotension and Bedside Leukocyte Reduction Filters

FDA has issued a letter to health professionals alerting to the possibility that patients who receive blood products transfused through a bedside leukocyte reduction filter may develop a precipitous drop in blood pressure. These reactions have a rapid onset. In some cases, patients also develop respiratory distress and shock. In most situations, the reactions resolve when the transfusion is discontinued and when appropriate medical intervention is performed.
[May 4, 1999 (Safety Notice) - FDA]

DawnMist Mouth Rinse

FDA Update 3/27/2002: Donovan Industries Recall F-543-9, Class I, on DawnMist Mouthrinse was complete and effective and disposition was completed on 8/30/99.

April 16, 1999 - Donovan Industries, Inc., Tampa, FL recalled all lots of DawnMist Mouth Rinse made in Malaysia because the product may be contaminated with Burkholderia cepacia. The product is packaged in 2 oz. and 4 oz. white plastic containers and was distributed nationwide to hospitals and other medical institutions. Burkholderia cepacia is a nosocomial pathogen and can be responsible for ventilator-associated pneumonia.
[April 16, 1999 (Letter to Customers) - Donovan Industries] UPDATED 3/27/2002

PLAS+ SD (pooled plasma, solvent detergent treated)

V.I. Technologies is voluntarily recalling seven lots of PLAS+ SD to reduce risk from parvovirus B19 infection.
[April 16, 1999 (Notice) - FDA]
[May 4, 1999 (Notice) - FDA] Additonal lots recalled.
[May 14, 1999 (Notice) - FDA] Additonal lots recalled.

Xeloda (capecitabine)

Roche notifies health professionals of reports of altered coagulation parameters and/or bleeding in cancer patients on Xeloda (capecitabine) who were taking coumarin derivatives concomitantly.
[March, 1999 (Letter ) - Roche]

Philips Medical SD800 Diagnostic Ultrasound System (Hewlett-Packard)

Hewlett-Packard has found that when the Philips Medical SD800 Ultrasound System is used with the Philips Model EV7014 Endovaginal Transducer to perform a needle biopsy, the biopsy guiding graphic overlay generated by the software system, incorrectly indicates the track of a needle biopsy held in the biopsy guidance attachment. The graphic overlay indicates a track that is 90 degrees from the actual orientation of the needle. If the overlay graphic is used as the sole guide the needle may penetrate and potentially damage unintended target tissue, causing bleeding or other complications, and if a fetus is present in the uterus, result in fetal injury or death.
[March 26, 1999 (Letter ) - Hewlett-Packard]

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Immune Globulin Intravenous for Treatment of Immune Deficient Patients - United States, 1997-1998

Immune globulin intravenous (IGIV) is a lifesaving treatment for patients with primary immunodeficiency. Since November 1997, a shortage of IGIV has existed in the United States. In 1998, the FDA required pharmaceutical companies to increase the frequency of reporting on IGIV distribution from biannually to monthly. To assess the impact of the IGIV shortage on patient care, in 1998 the Immune Deficiency Foundation (IDF) surveyed physicians caring for immunodeficient patients. This report summarizes data reported to FDA and data obtained from the IDF and provides recommendations for IGIV use during the shortage.
[March 5, 1999 ( MMWR PDF Version )

Hemolysis Associated with 25% Human Albumin Diluted with Sterile Water - United States, 1994-1998

Since 1994, a shortage of 5% human albumin, a product used off-label during therapeutic plasma exchange (TPE), has existed in the United States. Because of this shortage, hosptial pharmacists may prepare 5% solution of human albumin by diluting 25% human albumin with 0.9% NaCl or, when sodium load is a concern, 5% Dextrose. However, if sterile water alone is used as the diluent, the osmolarity (tonicity) of the albumin solution is reduced and may cause hemolysis in recipients. This report describes two of 10 episodes of hemolysis (one fatal) among persons who received 25% human albumin diluted with sterile water.
[March 5, 1999 ( MMWR PDF Version )

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Tampons and Asbestos, Dioxin & Toxic Shock Syndrome
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 updates information orginally provided 12/21/98.
[February 22, 1999 (Information Sheet Text, PDF) - FDA]

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Glass Capillary Tubes
The FDA, The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), and the Occupational Safety and Health Administration (OSHA) alert health professionals to the potential risk of injury and/or infection from bloodborne pathogens, including human immunodeficiency virus (HIV), hepatitis B and hepatitis C viruses, due to accidental breakage of glass capillary tubes, and recommend certain steps that can minimize the risk.
[February 1999 ( Joint Safety Advisory) - FDA/NIOSH/OSHA]

Life Support Products Oxygen Regulators
Allied Healthcare Products is recalling all oxygen regulators sold under the Life Support Products brand because of reports of fires and explosions
[February 1999 ( Press Release) - Allied Healthcare Products]
[2/4/99 ( Public Health Advisory) - FDA]

Cerebyx (fosphenytoin)
Parke-Davis has notified healthcare professionals that it is revising the vial and carton labels for Cerebyx. Massive overdoses of Cerebyx associated with serious adverse events, including death, have resulted from health care workers' mistaken interpretation of the current vial label (both 2mL and 10mL vials). Specifically, some health care workers withdrawing Cerebyx from the vial have misinterpreted the vial label to mean that the amount of phenytoin equivalents per milliliter actually represents the total amount of phenytoin equivalents in the vial.
[January 1999 ( Letter), (PDF version ) - Parke-Davis]

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Tripedia (diphtheria/tetanus toxoids/acellular pertussis vaccine adsorbed)

Connaught has initiated a recall of Tripedia Lot# 0916490 because of low potency of the diphtheria component
[January 27, 1999 ( Notice) - FDA]
[January 27, 1999 ( Letter) - Connaught]
[January 29, 1999 (Talk Paper) - FDA]
[February 4, 1999 (Letter, PDF Version ) - FDA]

Abbokinase (urokinase)

FDA recommends that Abbokinase be reserved for only those situations where a physician has considered the alternatives and has determined that the use of Abbokinase is critical to the care of a specific patient in a specific situation. Healthcare providers are also informed of important safety information regarding the use of Abbokinase (Urokinase). The information is intended to help physicians and patients understand the potential risks of transmitting infectious agents associated with the use of this product.
[January 25, 1999 ( Letter, PDF Version - FDA]
[March 16, 1999 (Update) - FDA]
[March 22, 1999 ( Update) - FDA]
[March 22, 1999 (Warning Letter PDF Version ) - FDA]
[July 16, 1999 (New Update:Serious Manufacturing Deficiencies Prompt FDA Letter]

Asian Remedy for Menstrual Cramps

CDC reports a case of adult lead poisoning attributed to an Asian remedy for menstrual cramps, "Koo Sar" pills, following an investigation by the Adult Lead Registry of the Connecticut Department of Public Health (CDPH), Division of Environmental Epidemiology and Occupational Health.
[January 22, 1999 ( MMWR Weekly) - CDC]

Gamma Butyrolactone (GBL)

FDA warns consumers about products containing GBL, some marketed as dietary supplements. FDA has received reports of serious health problems - some life-threatening - associated with their use. Brand names include Renewtrient, Revivarant, Revivarant G, Blue Nitro, Blue Nitro Vitality, GH Revitalizer, Gamma G and Remforce.
[January 21, 1999 (Talk Paper) - FDA]
[February 26, 1999 ( MMWR Weekly) - CDC]

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Trovan (alatrofloxacin mesylate)

Pfizer notifies health care professionals that the prescribing information for Trovan I.V. (alatrofloxacin mesylate injection) has been amended to include information on the potential incompatibility of alatrofloxacin mesylate injection with two commonly used diluents, 0.9% sodium chloride injection, USP (usually referred to as normal saline solution) and Lactated Ringer's, USP.
[January 12, 1999 ( Letter) - Pfizer]

Flovent (fluticasone propionate)

Glaxo Wellcome notifies health professionals of rare cases of patients on inhaled fluticasone propionate presenting with systemic eosinophilic conditions, some with clinical features of vasculitis consistent with Churg-Strauss syndrome.
[January 1999 (Letter) - Glaxo Wellcome]

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Y2K Biomedical Equipment Clearinghouse

FDA alerts biomedical equipment manufacturers of plans to expand the medical device information on Year 2000 Non-Compliant and Compliant Products located on the Federal Y2K Biomedical Equipment Clearinghouse and asks for their cooperation in this effort. Further instructions provided March 3, 1999.
[January 13, 1999 (Letter) - FDA]
[March 3, 1999 ( Letter) - FDA]

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