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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 (Rh_o(D) Immune Globulin Intravenous (Human))(Posted: 1/07/2000)

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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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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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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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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.]

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™ (Rh_o(D) Immune Globulin Intravenous (Human))

Health professionals are notified of updated prescribing and treatment information regarding use of WinRho SDF™ (Rh_o(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 Rh_o(D) antigen (D-positive), we have revised the package insert to state that "Rh_o(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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