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
(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:
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)
Return to Quick Reference
Dietary Supplements:
Return to Quick Reference
Drugs:
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)
Return to Quick Reference
Medical Devices:
Return to Quick Reference
Other Products:
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
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- 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]
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- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
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- 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.]
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- 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]
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- 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]
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- 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]
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- 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]
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- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- Xenical (orlistat)/Xeloda (capecitabine)
- The company notifies health professionals of 2 reports of dispensing errors
involving Xenical and Xeloda.
[August 1999 (Letter
- Roche]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
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- 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]
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- 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]
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- 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]
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- 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]
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- 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]
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- 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]
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- 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]
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- 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]
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- 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)]
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- 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]
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- 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]
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- 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]
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- 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]
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- 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
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- 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.
Return to Quick Reference
- 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]
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- 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 )
Return to Quick Reference
- 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]
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- 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]
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- 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]
Return to Quick Reference
- 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]
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- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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]
Return to Quick Reference
- 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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