2000 Safety Alerts for Drugs, Biologics, Medical
Devices, and Dietary Supplements
Last updated: January 3, 2001
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Biologics:
Actimmune (Interferon gamma-1b)(Posted: 6/16/2000)
Allergenic Extract - Tuna (Posted: 11/2/2000)
Anti-thymocyte Globulin (Rabbit), Thymoglobulin (Posted
8/11/2000)
Anthrax Vaccine Adsorbed (Posted 9/12/2000)
Bovine Spongiform Encephalopathy (BSE) Information (Posted
12/22/2000)
Carticel (autologous cultured chondrocytes)(Posted: 3/16/2000)
Collagenase, Santyl Ointment (Posted 9/8/2000)
Diagnostic Allergenic Extracts (Posted 9/26/2000)
Diphtheria & Tetanus Toxoids Adsorbed (Posted 9/12/2000)
Enbrel (etanercept)(Updated: 10/11/00, Posted: 5/12/2000)
Epogen (epoetin alfa)(Posted: 3/24/2000)
Fibrin Sealant Vapor Heated, Tisseel VH, 2.0 mL (Posted
8/11/2000)
Unapproved Goat Serum Treatment for HIV/AIDS (Posted 12/22/2000)
Haemophilus b Conjugate Vaccine (HibTITER) (Posted 8/11/2000)
Helixate (antihemophilic factor [recombinant]) (Posted
8/8/2000)
Herceptin (trastuzumab) (Updated: 10/16/00; Posted 5/8/2000)
IMOVAX Rabies I.D. (Rabies Vaccine) (Posted 7/31/2000)
Kogenate (antihemophilic factor [recombinant]) (Posted
8/8/2000)
Mumps Skin Test Antigen (Posted: 11/17/2000)
Murex SUDS HIV-1 (rapid EIA) (Posted 10/17/2000)
Orimune (Poliovirus Vaccine Live Oral Trivalent)(Posted:
2/15/2000)
PLAS+SD (Pooled Plasma, [Human] Solvent Detergent Treated)
(Posted 10/20/2000)
Pulmozyme (dornase alfa, recombinant) (Posted 10/12/2000)
Pulmozyme (dornase alfa, recombinant) (Posted 4/20/2000)
Sepacell (Pre-storage Leukocyte Reduction Set for Red Cells)
(Posted 9/26/2000)
Simulect (basiliximab) (Posted 10/10/2000)
Urokinase 9000 IU (for catheter clearance) (Posted 10/2/2000)
WinRho SDF (Rho(D) Immune Globulin Intravenous
(Human))(Posted: 1/07/2000)
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Dietary Supplements:
Aristolochic Acid (Posted: 6/01/2000)
St. John's Wort (hypericum perforatum)(Posted: 2/10/2000)
Tiratricol (triiodothyroacetic acid)(Posted: 11/22/2000)
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Drugs:
Accolate (zafirlukast) (Posted: 9/15/2000)
Aerosol Inhalers Recall--Proventil (albuterol) & Vanceril
(beclomethasone dipropionate) (Posted: 3/29/2000)
Agenerase (amprenavir) (Posted: 5/1/2000)
Clinipad Corporation Products (Updated: 4/13/00; Posted:
3/10/2000)
Colchicine (Updated 1/26/01 -- News Release; Posted: 12/23/2000)
Depakote (divalproex sodium delayed-release tablets) and Depakote
(divalproex sodium coated particles in capsules)(Posted: 7/31/2000)
Depacon (valproate sodium injection)(Posted: 7/31/2000)
Depakene (valproic acid capsules and syrup)(Posted: 7/31/2000)
Eskalith CR (lithium carbonate) controlled release 450
mg tablets(Posted: 3/17/2000)
Etodolac Capsules 300 mg. (Posted: 10/10/2000)
Sterile FUDR (floxuridine) (Posted: 2/03/2000)
Fluothane (halothane, U.S.P.) (Posted: 3/15/2000)
Lamictal (lamotrigine) and Lamisil (terbinafine hydrochloride)
(Updated: 8/2000; Posted: 6/28/2000)
Lithobid (lithium carbonate 300 mg slow-release tablets) (Posted:
8/9/2000)
Lotronex (alosetron hydrochloride) Tablets (Updated: 11/29/00--Market
withdrawal; Posted: 8/24/2000)
Mellaril (thioridazine HCL) (Posted: 7/24/2000)
Norplant (levonorgestrel implants) (Updated: 9/13/2000)
Phenylpropanolamine hydrochloride (PPA) (Posted: 11/6
/2000)
Propulsid (cisapride) (Updated: 4/13/2000, 3/23/2000--Market
Withdrawal; Posted: 1/24/2000)
Public Health Advisory: Influenza Drugs (Posted: 1/12/2000)
Relenza (zanamivir for inhalation)(Posted: 7/10/2000)
Rezulin (troglitazone) (Posted: 3/22/2000)
SangCya (Cyclosporine Oral Solution, USP (MODIFIED) (Posted:7/10/2000)
Serentil (mesoridazine besylate) (Posted 10/10/2000)
Sterile Talc Powder, Product 1690 (Posted: 9/12/2000)
Techni-Care Surgical Prep (Posted: 1/24/2000)
triCitrasol (Posted: 4/17/2000)
Videx (didanosine) (Posted: 8/9/2000)
Viramune (nevirapine) (Posted: 11/9/2000)
Xeloda (capecitabine) (Posted: 11/28/2000)
Ziagen (abacavir sulfate) (Updated 7/27/2000; Posted:
1/24/2000)
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Medical Devices:
BACTEC S.I.R.E Kits (Isoniazid for antimicrobial susceptibility
testing (AST) of Mycobacterium tuberculosis). (Posted 9/5/2000)
Circumcision Clamps (Posted 9/5/2000)
Microwave Thermography--Serious Injuries With Use for Benign
Prostatic Hyperplasia (Posted: 10/11/2000)
Possible Leap Year Date-Related Problems with Medical Devices
(Posted: 2/24/2000)
Risk of Electromagnetic Interference with Medical Telemetry
Systems (Posted: 7/11/2000)
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Other Products:
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2000 Medical Product Safety Alerts, listed in reverse
chronological order. For an alphabetical listing, return to the categories
on this page. You may also search the entire MedWatch
site by keyword at the top of this Safety Information page.
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- Goat antiserum to treat HIV/AIDS
- The FDA is advising health care providers and patients that goat antiserum
to treat HIV/AIDS is not currently approved for the treatment of HIV/AIDS
or for any human clinical study. This unapproved product, produced in goats
as an antiserum against HIV/AIDS, was the subject of a "clinical hold" by
FDA, prohibiting its use until previously existing safety questions are resolved.
Please see the FDA Talk Paper at http://www.fda.gov/bbs/topics/ANSWERS/ANS01061.html
-
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- Bovine Spongiform Encephalopathy (BSE)
- The U.S. Food and Drug Administration (FDA) learned earlier this year that
some vaccines were manufactured with bovine-derived materials obtained from
countries in which bovine spongiform encephalopathy (BSE) or a substantial
risk for BSE exists. A "Notice to Readers: Public Health Service Recommendations
for the Use of Vaccines Manufactured with Bovine-Derived Materials" was published
in the MMWR December 22, 2000 [vol. 49(50);1137-8]. Find the CBER information
page on BSE at http://www.fda.gov/cber/bse/bse.htm
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- Colchicine and other injectable products
- Recall of injectable products due to lack of Current Good Manufacturing
including Colchicine labeled as .5 mg/mL, but actually formulated at 5 mg/mL.
[Updated January 26, 2001 (News
Release) - FDA]
[December 23, 2000 (Recall Notice) - FDA]
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- Xeloda (capecitabine)
- Important safety-related changes to the prescribing information concerning
the use of Xeloda in patients with renal impairment at baseline.
[November 28, 2000 (Letter) - Roche Pharmaceuticals]
[November 28, 2000 (Package
Insert) - Roche Pharmaceuticals]
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- Tiratricol (triiodothyroacetic acid)
- The FDA is again warning consumers of products marketed as dietary supplements
that contain tiratricol, a potent thyroid hormone that may cause serious health
consequences including heart attacks and strokes.
[November 22, 2000 (Talk
Paper) - FDA]
- Mumps Skin Test Antigen
- Voluntary recall of one lot. Results of routine stability testing conducted
by the manufacturer found that the potency of the lot had fallen below the
product specification prior to the product's expiration date.
[November 17, 2000 (FDA Notice)
- Aventis Pasteur Inc]
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- Viramune (nevirapine)
- The existing labeled warnings for the risk of hepatotoxicity with Viramune
treatment have been strengthened in response to continued reports of severe,
life-threatening and in some cases, fatal hepatotoxicity that have been reported
from clinical trials and postmarketing use with Viramune.
[November 9, 2000 (Health Professional Letter)
- Boehringer Ingelheim]
[November 9, 2000 (Health Professional Letter) PDF
Format
- Boehringer Ingelheim]
[November 9, 2000 (Package Insert) PDF Format
- Boehringer Ingelheim]
[November 9, 2000 (Patient Information) PDF Format
- Boehringer Ingelheim]
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- Phenylpropanolamine hydrochloride (PPA)
- FDA is taking steps to remove phenylpropanolamine hydrochloride from all
drug products due to the risk of hemorrhagic stroke. FDA has significant concerns
because of the seriousness of stroke and the inability to predict who is at
risk.
[November 6, 2000 (Public
Health Advisory) - FDA]
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- Allergenic Extract - Tuna, for Scratch, Prick or Puncture Testing)
- One lot of the product was recalled due to lack of assurance of sterility.
While the required sterility tests results were acceptable following manufacture
of this lot, a subsequent review of the test results and an associated internal
investigation resulted in questions regarding the conclusions made at the
time of release.
[October 3, 2000 (Recall
Notice) - FDA]
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- PLAS+SD (Pooled Plasma, [Human] Solvent Detergent Treated)
- A cluster of serious adverse events, in six (6) patients, occurring at a
single institution during orthotopic liver transplantation. All six patients
died due to thrombotic events or excessive bleeding during the transplant
procedure. All patients received intra-operative PLAS+SD along with multiple
other blood components. Letter reviews storage and handling of PLAS+SD.
[October 20, 2000 (Letter) PDF Format
- VITEX, V. I. Technologies, Inc]
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- Murex SUDS HIV-1 (Rapid EIA)
- Abbott is experiencing manufacturing problems related to the failure to
meet certain panel and negative control specifications. As a result, Abbott
has exhausted its supply of the HIV SUDS product.
[October 17, 2000 (Letter) - Abbott]
[October 17, 2000 (Letter) PDF Format
- Abbot]
[October 18, 2000 (Information
Sheet) - FDA]
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- Microwave Thermography--Serious Injuries With Use for Benign Prostatic
Hyperplasia
- Potential for serious thermal injury and related complications associated
with the use of microwave energy to treat benign prostatic hyperplasia (BPH).
Thermal injuries have resulted in fistula formation and clinically significant
tissue damage to the penis or urethra requiring colostomies, partial amputation
of the penis, and/or other therapeutic interventions.
[October 11, 2000 (Public Health Notice)
- FDA]
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- Serentil (mesoridazine besylate)
- Important labeling changes for all dosage forms of Serentil including a
boxed WARNING to advise clinicians that Serentil has been shown to prolong
the QTc interval in a dose related manner and drugs with this potential have
been associated with torsade de pointes-type arrhythmias and sudden death.
[September 22, 2000 (Letter) - Novartis]
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- Simulect (basiliximab)
- Postmarketing reports of seventeen cases of severe acute hypersensitivity
reactions, including anaphylaxis, occurring in patients following the administration
of Simulect. Other reactions may include hypotension, tachycardia, cardiac
failure, dyspnea, wheezing, bronchospasm, pulmonary edema, respiratory failure,
urticaria, rash, pruritus, and/or sneezing. The onset of these reactions occurred
within 24 hours following initial exposure and/or following re-exposure to
Simulect.
[October 6, 2000 (Letter) - Novartis]
[October 6, 2000 (Letter) PDF Format
- Novartis]
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- Etodolac Capsules 300 mg
- Results from routine product stability testing of Lot number 9991052 of
Etodolac Capsules found that some capsules from this lot may contain a variable
and unknown quantity of acebutolol hydrochloride a selective beta blocker,
indicated for the treatment of hypertension and ventricular arrhythmias. A
small number of capsules available for testing showed a range of acebutolol
of 0.4 mg to 135.3 mg per capusle. The maximum amount of acebutolol that could
be contained in a capsule of that size is 404 mg.
[October 6, 2000 (Letter) - ESI Lederle/Wyeth-Ayerst
Labs]
[October 6, 2000 (Letter) PDF Format )
- ESI Lederle/Wyeth-Ayerst Labs]
[October 6, 2000 (Pharmacist Letter) PDF Format
)
- ESI Lederle/Wyeth-Ayerst Labs]
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- Urokinase 9000 IU (for catheter clearance)
- This product is being recalled because it has not been approved by the FDA,
and therefore there is no assurance that the product is safe and effective
for its intended use. The drug was also manufactured under conditions which
are not in compliance with Current Good Manufacturing Practices which could
increase the risk of transmitting infectious agents.
[October 2, 2000 (Letter)
- Medicine Shoppe]
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- Allergenic Extract, Pork and Beef
- These Allergenic Extracts are used in allergy scratch, prick or puncture
diagnostic tests. The products were tested for sterility and passed. The manufacturer
initiated this recall after a subsequent lot of each product, manufactured
from the same bulk extract, failed sterility testing.
[September 19, 2000 (Letter)
- Hollister-Stier Laboratories LLC]
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- Sepacell--Pre-storage Leukocyte Reduction Set for Red Cells
- Voluntary recall. Occasional leaks during the process of leukoreduction
of units of Red Blood Cells intended for transfusion. FDA considers the risk
of bacteremia from Red Blood Cell units using Pre-storage Leukocyte Reduction
Set for Red Cells filters (Sepacell) to be very low.
[September 22, 2000 (Letter)
- FDA]
[September 19, 2000 (Letter)
- Baxter Healthcare Corp]
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- Accolate (zafirlukast)
- Revisions to the Precautions and Adverse Events sections of the labeling
for Accolate.
[September 2000 (Letter) - AstraZeneca]
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- Anthrax Vaccine Adsorbed
- A portion of the lot was labeled with an expiration date of September 8,
2001, rather than the correct expiration date of February 3, 2001. Bioport
employees will be traveling to distribution points and correcting the mislabeled
vials.
[August 28, 2000 (Notice)
- Bioport Corp]
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- Diphtheria & Tetanus Toxoids Adsorbed
- The manufacturer initiated the recall because they can not assure that the
product is sterile.
[August 28, 2000 (Notice)
- Bioport Corp]
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- Sterile Talc Powder, Product 1690
- Bryan Corporation, Woburn, MA is voluntarily recalling all lots of Sterile
Talc Powder, 4 grams in a 100ml amber vial, (Product 1690) as the product
may be non-sterile, misbranded and is considered by the FDA to be an unapproved
New Drug.
[August 28, 2000 (Notice) - Bryan Corp]
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- Collagenase, Santyl Ointment
- Testing of the bulk ointment failed sterility testing. The lot was released
because the finished product passed the sterility test. However, the source
of the organism found in the bulk test sample was never identified.
[August 28, 2000 (Notice)
- Advance Biofactures Corp]
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- Circumcision Clamps
- Potential for injury from two commonly used circumcision clamps, the Gomcor/gomco-type
and Mogenr/mogen-type clamps. Both are widely used during circumcision to
remove the foreskin while protecting the glans penis. FDA received 105 reports
of injuries involving circumcision clamps between July 1996 and January 2000.
These have included laceration, hemorrhage, penile amputation, and urethral
damage.
[September 1, 2000 (Device
Safety Notification) - FDA]
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- Haemophilus b Conjugate Vaccine (HibTITER)
- Wyeth-Ayerst Pharmaceutical became aware that 5 cartons (each containing
80 multidose vials) of HibTITER Haemophilus b Conjugate Vaccine, Lot 613803A,
were shipped inappropriately, in that the product was shipped by airfreight
without a documented freeze indicator. Wyeth-Ayerst Pharmaceutical has initiated
a recall of vials in question from Lot 613803A and is arranging for replacement
of the subject vaccine. The firm is not recommending revaccination of children
who have previously received vaccine from Lot 613803A.
[September 1, 2000 (Notice)
- FDA]
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- BACTEC S.I.R.E Kits (Isoniazid for antimicrobial susceptibility testing
(AST) of Mycobacterium tuberculosis)
- Becton Dickinson Biosciences (Sparks, Maryland) has issued a voluntary recall
of a lot of isoniazid [INH] (drug lot no. 9335260) used for antimicrobial
susceptibility testing (AST) of Mycobacterium tuberculosis. The recalled INH
lot was sold as components of BACTEC S.I.R.E. kits (lot nos. 9327296, 9342298,
and 9327298) and as individual drug for reconstitution (BACTEC Isoniazid kit
lot no. 9327297) during January 2000--August 25, 2000.
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- Lotronex (alosetron hydrochloride) Tablets
- Glaxo Wellcome withdraws Lotronex tablets from the market.
[November 29, 2000 (Talk
Paper) - FDA.]
- Lotronex (alosetron hydrochloride) Tablets
- New safety information and labeling changes for Lotronex. This new information
pertains to reports of constipation, that in a few cases have resulted in
serious sequelae and infrequent reports of ischemic colitis occurring in association
with the use of Lotronex.
[August 24, 2000 (Health Professional Letter) - GlaxoWellcome,
Inc]
[August 24, 2000 (Pharmacist Letter) - GlaxoWellcome,
Inc]
[August 24, 2000 (Product
Information) - GlaxoWellcome, Inc]
[August 24, 2000 (Patient
Medication guide) - GlaxoWellcome, Inc]
[August 30, 2000 (Questions
and Answers) - FDA]
[August 24, 2000 (Press Release)
- FDA]
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- Norplant (levonorgestrel implants)
- Health professionals are asked to discontinue insertion of Norplant System
from kits with a package expiration date that includes the year 2004. During
regular quality assurance monitoring, representative samples of several product
lots tested within product specificaitons, but at the lower end of the release
rate specification for shelf life stability.
[September 13, 2000 Update Letter - Wyeth-Ayerst]
[September 13, 2000 FDA
Talk Paper - FDA]
[August 10, 2000 (Letter) - Wyeth-Ayerst]
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- Anti-thymocyte Globulin (Rabbit), Thymoglobulin
- Testing conducted after shipping found that the lot exceeded a potency specification
which has the potential to cause prolonged neutropenia. This product is indicated
for the treatment of renal transplant acute rejection in conjunction with
concomitant immunosuppression.
[August 9, 2000 (Letter)
- SangStat Medical Corp.]
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- Fibrin Sealant Vapor Heated, Tisseel VH, 2.0 mL
- During transport for distribution the storage temperature dropped to just
below the freezing point for one of the components of the kit, Fibrinolysis
Inhibitor Solution (Aprotinin). This temperature deviation could lead to damage
to the Aprotinin vial.
[August 8, 2000 (Letter)
- Baxter Healthcare Corp.]
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- Videx (didanosine)
- Change in prescribing information based on results of a recently completed
clinical trial. Although once-daily dosing is available, it should only be
considered for adult patients whose management requires once-daily administration
of Videx. The preferred dosing frequency of Videx is twice-daily because there
is more evidence to support the effectiveness of this dosing frequency.
[August 1, 2000 (Letter) - Bristol-Myers Squibb.]
[August 1, 2000 (Letter) - Bristol-Myers Squibb.]
PDF Format
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- Lithobid (lithium carbonate 300 mg slow-release tablets)
- Health professionals are notified of a temporary reduction in the expiration
dating for Lithobid. This change is due to Solvay's recent need to find a
new source for its raw material, lithium carbonate.
[August 8, 2000 (Letter) - Solvay Pharmaceuticals]
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- Kogenate (antihemophilic factor [recombinant])
- Voluntary withdrawal of Kogenate lot numbers 670H071C and 670H076. This
lot of Kogenate was tested for Factor VIII potency using a reagent known as
FVIII-deficient plasma. During a routine quality assurance investigation of
the testing procedure, Bayer learned that Lot 670H071 may not retain its labeled
potency if held at room temperature (25° C) for 3 months. The product will
remain stable if refrigerated. Further investigation has confirmed that the
cause is not related to a stability issue with the product but is attributed
to the reagent used during the initial testing. As of this date there have
been no adverse events reported in association with these lots.
[July 27, 2000 (Letter) - Bayer]
[July 27, 2000 (Letter) - Bayer] PDF Format
[July 27, 2000 (Notice)
- FDA]
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- Helixate (antihemophilic factor [recombinant])
- Voluntary withdrawal of Helixate lot number 670H071E. This lot of Helixate
was tested for Factor VIII potency using a reagent known as FVIII-deficient
plasma. During a routine quality assurance investigation of the testing procedure,
Bayer learned that Lot 670H071 may not retain its labeled potency if held
at room temperature (25° C) for 3 months. The product will remain stable if
stored at 2-8° C. Further investigation has confirmed that the cause is not
related to a stability issue with the product but is attributed to the reagent
used during the initial testing. As of this date there have been no adverse
events reported in association with this lot of Helixate.
[August 1, 2000 (Letter) - Aventis Behring]
[August 1, 2000 (Letter) - Aventis Behring] PDF Format
[July 27, 2000 (Notice)
- FDA.]
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- Depakote (divalproex sodium delayed-release tablets), Depakote
(divalproex sodium coated particles in capsules), Depacon (valproate
sodium injection), Depakene (valproic acid capsules and syrup)
- Update to the WARNINGS section in the labeling. Cases of life-threatening
pancreatitis have been reported in both children and adults receiving valproate.
Some of the cases have been described as hemorrhagic with a rapid progression
from initial symptoms to death.
[July 2000 (Letter) - Abbott Laboratories.]
[July 2000 (Letter) PDF Format
- Abbott Laboratories.]
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- IMOVAX Rabies I.D. (Rabies Vaccine)
- IMOVAX Rabies I.D. (Rabies Vaccine) is used for pre-exposure prophylaxis
against rabies. In the course of routine stability testing, Aventis Pasteur
learned that the potency of lot number P0313-3 had fallen below specification
24 months after manufacturing. Although this product met all specifications
at the time of release, its potency fell below specification prior to the
product's expiration date. Lot numbers P0030-2 and N1204-2 are also being
recalled as a precautionary measure since all three lots were prepared from
the same initial bulk lot.
[July 28, 2000 (Letter)
- Aventis Pasteur Inc.]
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- Mellaril (thioridazine HCL)
- Health professionals are notified of important labeling changes for all
dosage forms of Mellaril. The new changes include a boxed warning, a change
in the indication, contraindications with certain other drugs, and new recommendations
for baseline monitoring and overdosage treatment.
[July 7, 2000 (Letter) - Novartis Pharmaceuticals
Corp.]
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- Risk of Electromagnetic Interference with Medical Telemetry Systems
- Existing wireless medical telemetry systems may be at increased risk of
electromagnetic interference (EMI) if they continue to operate in the range
of frequencies in which most medical telemetry devices are currently operating.
To address this risk, the Federal Communications Commission (FCC) has created
a new Wireless Medical Telemetry Service (WMTS) that will allow medical telemetry
systems to operate on an interference-protected basis.
[July 10, 2000 (Letter) - FDA.]
[July 10, 2000 (Letter) PDF
Format
- FDA.]
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- SangCya (Cyclosporine Oral Solution, USP (MODIFIED), 100mg/mL), 50 mL
bottle
- Health professionals are notified of a voluntary recall of SangCya (Cyclosporine
Oral Solution, USP (MODIFIED), 100mg/mL), 50 mL bottle. A study in healthy
volunteers has identified that SangCya is not bioequivalent to Neoral oral
solution when mixed with apple juice as recommended in its labeling. SangStat
is taking this Class II recall action with the knowledge of the FDA.
[July 10, 2000 ( Health Professional Letter) - SangStat
Medical Corporation]
[July 10, 2000 ( Wholesale Dist. Letter) - SangStat
Medical Corporation]
[July 10, 2000 (Talk Paper
) - FDA]
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- Relenza (zanamivir for inhalation)
- Health professionals are notified of important revisions to the safety labeling
for Relenza. The labeling has been revised to more clearly reflect that serious
respiratory adverse events have been reported in patients with or without
known underlying respiratory disease, and to incorporate additional updated
safety information.
[July 2000 (Letter) - Glaxo Wellcome, Inc.]
[July 2000 (Letter) PDF Format
- Glaxo Wellcome, Inc.]
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- Lamictal (lamotrigine) Tablets and Lamisil (terbinafine hydrochloride)
Tablets
- This is a revised version of the June letter. This letter has: an "Important
Drug Warning" boxed header, current MedWatch information and a July date.
All other information is the same.
[July 2000 (Letter) - Glaxo Wellcome, Inc.]
[July 2000 (Letter) PDF Format
- Glaxo Wellcome, Inc.]
- Lamictal (lamotrigine) Tablets and Lamisil (terbinafine hydrochloride)
Tablets
- Health professionals, especially pharmacists, are notified of prescription
dispensing errors involving Lamictal Tablets and Lamisil Tablets resulting
in serious adverse events. The error reports involve dispensing Lamictal Tablets
when Lamisil Tablets were prescribed and the reverse scenario.
[August 2000 (Health Professional Letter) - Glaxo
Wellcome, Inc.]
[August 2000 (Health Professional Letter) PDF Format
- Glaxo Wellcome, Inc.]
[June 6, 2000 (Pharmacist Letter) - Glaxo Wellcome,
Inc.]
[June 6, 2000 (Letter) PDF Format
- Glaxo Wellcome, Inc.]
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- Actimmune (Interferon gamma-1b) Injection
- Health professionals are notified of a change in the labeling of Actimmune.
The expression of potency has been changed from units to International units.
This labeling change is based on direct calibration of the Interferon gamma
reference standard to the WHO standard in the potency assay.
[June 14, 2000 (Letter) - InterMune Pharmaceuticals,
Inc.]
[June 14, 2000 (Letter) PDF Format
- InterMune Pharmaceuticals, Inc.]
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- Aristolochic Acid
- Health professionals are notified of FDA concerns regarding nephrotoxicity
associated with botanical products found to contain aristolochic acid.
[June 1, 2000 (Health
Professional Letter)- FDA/CFSAN.]
[June 1, 2000 (Attachments)-
FDA/CFSAN.]
[June 1, 2000 (Industry
Letter)- FDA/CFSAN.]
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- Enbrel (etanercept)
- Post-marketing reports of adverse events of rare cases of nervous system
disorders including demyelinating disorders such as multiple sclerosis, myelitis,
and optic neuritis have been reported in patients with rheumatoid arthritis
who have received Enbrel therapy.
[October 10, 2000 (Letter) - Immunex Corp./Wyeth-Ayerst
Pharmaceuticals.]
[October 10, 2000 (Letter) PDF Format - Immunex Corp./Wyeth-Ayerst
Pharmaceuticals.]
- Enbrel (etanercept)
- Health professionals are asked to help reduce difficulties experienced by
some patients with self-administration of Enbrel. The main difficulty is in
penetrating the vial stopper with the needle on the supplied syringe, resulting
in bent and otherwise damaged needles.
[May 12, 2000 (Letter)- Immunex Corp./Wyeth-Ayerst
Pharmaceuticals.]
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- Herceptin (trastuzumab)
- Follow-up to May letter. Changes to BOXED WARNINGS, WARNINGS, and ADVERSE
REACTIONS sections.
[October 6, 2000 (Letter) - Genentech, Inc.]
[October 6, 2000 (Letter) PDF Format - Genentech, Inc.]
[October 6, 2000 (Package Insert) PDF Format - Genentech, Inc.]
- Herceptin (trastuzumab)
- Health professionals are notified of 62 postmarketing reports of serious
adverse events related to the use of Herceptin. The serious adverse events
are characterized by one or more of the following categories: hypersensitivity
reactions, infusion reactions, and pulmonary reactions. Fifteen (15) patients
died and nine (9) of these patients had onset of symptoms within 24 hours
of infusion.
[May 3, 2000 (Letter)- Genentech, Inc.]
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- Agenerase (amprenavir)
- Health professionals are notified of important changes to the labeling for
Agenerase Oral Solution. These changes highlight the potential risks, associated
with the large amount of the excipient propylene glycol in Agenerase Oral
Solution.
[May 1, 2000 (Letter) - GlaxoWellcome.]
[May 1, 2000 (Letter) PDF Format - GlaxoWellcome.]
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- Pulmozyme (dornase alfa, recombinant)
- Genentech, Inc. is voluntarily recalling one lot of Pulmozyme because an
unapproved re-filtration step was utilized to remove metal particulates that
had been found in the concentrated bulk drum substance.
[October 12, 2000 (Notice)
- FDA.]
- Pulmozyme (dornase alfa, recombinant)
- Genentech, Inc. is voluntarily recalling specified lots of Pulmozyme due
to a potential packaging defect which could result in ampule leakage. This
product withdrawal is limited to the distributor and sub-distributor levels
only, including chain distribution centers and pharmacies.
[April 20, 2000 (Pharmacist Letter) - Genentech,
Inc.]
[April 20, 2000 (Distributor Letter) - Genentech,
Inc.]
[April 20, 2000 (Lot Numbers) - Genentech, Inc.]
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- triCitrasol
- Cytosol Labs and Medcomp are voluntarily recalling triCitrasol, an unapproved
product that has been used to keep bloodlines open and may cause death when
infused into patients. FDA has learned that a patient died of cardiac arrest
shortly after triCitrasol, a 46.7% concentration of sodium citrate anticoagulant,
was injected full strength into a hemodialysis permanent blood access catheter
that had just been implanted. Rapid or excessive infusion of citrate solutions
can cause fatal heart arrhythmias, seizures or bleeding due to loss of blood
calcium.
[April 14, 2000 (Talk
Paper) - FDA]
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- Aerosol Inhalers Recall--Proventil (albuterol) & Vanceril (beclomethasone
dipropionate)
- Schering Laboratories is voluntarily recalling certain prescription inhalation
aerosol asthma products that were manufactured prior to Sept. 30, 1999, with
the exception of those already-opened Proventil albuterol inhalers
and Proventil inhaler refills or Warrick brand of albuterol inhalers and Warrick
inhaler refills that are currently being used by asthma patients with good
results.
[March 29, 2000 (Letter--Proventil) - Schering Laboratories]
[March 29, 2000 (Letter--Vanceril 42 mcg & 84 mcg)
- Schering Laboratories]
[March 29, 2000 (Press Release) - Schering Laboratories]
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- Epogen (epoetin alfa)
- Health professionals/dialysis clinicians are notified of problems with multiple
use of labeled single use Epogen vials. Amgen was made aware of 21 episodes
of bacteremia or pyrogenic reactions in patients receiving Epogen at a U.S.
dialysis unit. A Center for Disease Control and Prevention investigation revealed
that unused portions of Epogen remaining in single dose preservative-free
vials were collected and pooled into common vials for use in other patients.
These practices were linked to extrinsic bacterial contamination of Epogen.
[March 24, 2000 (Letter) - Amgen] PDF Format
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- Rezulin (troglitazone)
- Parke-Davis/Warner Lambert agree to FDA's request to withdraw Rezulin from
the market. FDA asked Parke-Davis/Warner Lambert to withdraw Rezulin after
a review of recent safety data on Rezulin and two similar drugs, Avandia (rosiglitazone)
and Actos (pioglitazone), showed that Rezulin is more toxic to the liver than
the other two drugs. Data to date show that Avandia and Actos, both approved
in the past year, offer the same benefits as Rezulin without the same risk.
[March 21, 2000 (HHS News)
- Parke-Davis/Warner Lambert.]
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- Eskalith CR (lithium carbonate) controlled release 450 mg tablets
- SmithKline Beecham notifies health professionals that effective immediately,
they will distribute Eskalith CR controlled release 450 mg tablets from an
alternate manufacturing facility. The previously approved manufacturing facility
is no longer producing Eskalith CR 450 mg tablets. Product produced at the
new facility has been shown to be equivalent to Eskalith CR 450 mg tablets
manufactured at the previously approved site; however, long-term stability
data is still being collected on this product.
[March 2000 (Letter) - SmithKline Beecham.]
[March 2000 (Letter) - SmithKline Beecham.] PDF Format
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- Carticel (autologous cultured chondrocytes.)
- Genzyme notifies health professionals of changes in the product labeling
for Carticel. The change narrows the indication for Carticel to second line
therapy for the repair of cartilage defects of the femoral condyle.
[March 10, 2000 (Letter) - Genzyme.]
[March 10, 2000 (Letter) - Genzyme.] PDF Format
[March 10, 2000 (Revised package insert) - Genzyme.]
PDF Format
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- Fluothane (halothane, U.S.P.)
- Wyeth-Ayerst Laboratories notifies health professionals of changes to the
prescribing information for Fluothane. The changes are intended to highlight
and expand upon information already presented in the labeling for Fluothane.
Important new information has been included to reflect current scientific
opinion, accepted standards of care, and safety information in an effort to
ensure the anesthesia care provider remains informed in making treatment decisions
regarding the administration of Fluothane.
[March 10, 2000 (Letter) - Wyeth-Ayerst Laboratories.]
[March 10, 2000 (Letter) - Wyeth-Ayerst Laboratories.]
PDF Format
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- Clinipad Corporation--Urgent Drug Recall
- The Clinipad Corporation is voluntarily recalling all Povidone Iodine, Tincture
of Iodine, Benzoin Tincture, Acetone Alcohol and Alcohol Antiseptic products
(swabsticks, prep pads, towelettes, and pouches), as well as, Cliniguard Protective
Dressing labeled as "sterile" that were manufactured over the last
three years. The reason for this recall is that the company has confirmed
microbial contamination in some lots of its sterile products, including one
lot with Pseudomonas aeruginosa, Stenotrophomonas maltophilia, and Coagulase
Negative Staphylococcus.
[March 9, 2000 (Customer Letter) - The Clinipad Corporation]
[March 9, 2000 (Kit Repacker Letter) - The Clinipad
Corporation]
[March 9, 2000 (Sterile Product List) - The Clinipad
Corporation]
[March 9, 2000 (Nonsterile Product List) - The
Clinipad Corporation]
[March 10, 2000 (Arm Preparation
Procedures) - FDA]
[March 10, 2000 (Questions
and Answers Regarding Clinipad Recall) - FDA]
[March 10, 2000 (HHS News)
- FDA]
[March 29, 2000 (CDRH Letter)
- FDA]
[April 13, 2000 (CBER Notice)
- FDA]
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- Possible Leap Year Date-Related Problems with Medical Devices
- Users and manufacturers of medical devices are notified of possible leap
year date-related problems with medical devices. With the approach of February
29, you should be prepared for the possibility of date-related problems associated
with the leap year rollover. Because problems could occur on or after February
29, 2000, FDA reminds you to review your contigency plans and heighten your
level of vigilance for possible problems during this time.
[February 22, 2000 (Notice)
- FDA.]
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- Orimune (poliovirus vaccine live oral trivalent)
- Health professionals are notified of a recent change in storage conditions
for Orimune.
[February 7, 2000 (Letter) - Wyeth-Lederle Vaccines
and Pediatrics.]
[February 7, 2000 (Letter) - Wyeth-Lederle Vaccines
and Pediatrics.] PDF Format
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- St John's Wort (hypericum perforatum)
- Health professionals are notified of the risk of drug interactions with
St. John's Wort, Indinavir and other drugs.
[February 10, 2000 (Public
Health Advisory) - FDA.]
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- Sterile FUDR (floxuridine)
- Health professionals are notified of the unavailability of Sterile FUDR
as a result of manufacturing issues.
[January 24, 2000 (Letter) PDF Format -
Roche Pharmaceuticals.]
[January 24, 2000 (Letter) - Roche Pharmaceuticals.]
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- Ziagen (abacavir sulfate)
- Health professionals are notified of severe hypersensitivity reactions following
reintroduction with Ziagen. Fatal hypersensitivity reactions are a described
risk associated with the use of abacavir. Recent reports indicate that severe
or fatal hypersensitivity reactions can occur within hours after Ziagen reintroduction
in patients who have no identified history or unrecognized symptoms of hypersensitivity
to abacavir therapy.
[July 2000 (Letter) - Glaxo Wellcome Inc.]
[July 2000 (Letter) PDF Format -
Glaxo Wellcome Inc.]
- Ziagen (abacavir sulfate)
- Health professionals are notified of a revised WARNING in the labeling for
Ziagen about fatal hypersensitivity reactions to abacavir in patients presenting
with respiratory symptoms.
[January 24, 2000 (Letter) - Glaxo Wellcome Inc.]
[January 24, 2000 (Letter) PDF Format -
Glaxo Wellcome Inc.]
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- Techni-Care Surgical Prep, Lot#1723
- Health professionals are notified of an urgent product recall of Techni-Care
Surgical Prep due to contamination with Pseudomonas aeruginosa.
[January 24, 2000 (Letter) - Care-Tech Laboratories
Inc.]
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- Propulsid (cisapride)
- Health professionals are notified that Janssen Pharmaceutica Inc., has announced
it will stop marketing Propulsid in the United States as of July 14, 2000.
The effective date of the voluntary action is intended to provide adequate
time for patients and their health care providers to make alternative treatment
decisions.
[March 23, 2000 (Talk
Paper) - FDA]
[April 13, 2000 (Letter) - Janssen Pharmaceutica]
- Propulsid (cisapride)
- Health professionals are notified of important changes in the Propulsid
labeling to reflect new safety information, including recommendations for
performing diagnostics tests prior to any Propulsid use.
[January 24, 2000 (Letter) - Janssen Pharmaceutical
Research Foundation]
[January 24, 2000 (Talk
Paper) - FDA]
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- Public Health Advisory: Safe and Appropriate Use of Influenza Drugs
- Health professionals, especially prescribers, are reminded of important
clinical decisions that need to be made when considering use of anti-viral
drugs for signs and symptoms of influenza.
[January 12, 2000 (Public
Health Advisory) - FDA]
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- WinRho SDF (Rho(D) Immune Globulin Intravenous (Human))
- Health professionals are notified of updated prescribing and treatment information
regarding use of WinRho SDF (Rho(D) Immune Globulin Intravenous
(Human)). Based on a recent assessment of adverse events following administration
of WinRho to immune thrombocytopenic purpura (ITP) patients positive for Rho(D)
antigen (D-positive), we have revised the package insert to state that "Rho(D)
positive patients treated with WinRho SDF should be monitored for signs and/or
symptoms of intravascular hemolysis (IVH), clinically compromising anemia,
and renal insufficiency."
[January 7, 2000 (Letter) - Cangene Corporation
and Nabi]
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