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The FDA Safety Information and Adverse Event Reporting Program

2002 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements

Last updated: April 1, 2003

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Click on one of the five categories below, then click on a product to go to the safety summary.

Biologics - Dietary Supplements - Drugs - Medical Devices - Other
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FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse products or companies.

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Biologics:

Abbokinase (urokinase) (Posted 10/21/2002)
Alpha Interferons (Roferon-A, Intron A, Rebetron Combination Therapy) (Posted 3/14/2002)
Epogen (Epoetin alfa) (Posted 5/20/2002)
Immune Globulin Intravenous (Human) [IGIV] (Posted 4/22/2002; UPDATED 8/27/2002)
PLAS+SD (Pooled Plasma,(Human) Solvent Detergent Treated) (Posted 5/9/2002)
Procrit (epoetin alfa) (Posted 6/11/2002; UPDATED 10/22/2002)
Synagis (palivizumab) (Posted 11/27/2002)

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Dietary Supplements:

Kava (Piper methysticum) (Posted 3/26/2002)
Milk Based Powdered Infant Formulas (Posted 4/12/2002)
Nettle Capsules (Posted 7/3/2002)
PC SPES, SPES (Posted 2/8/2002; UPDATED 9/20/2002)

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2002 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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Diathermy Interactions with Implanted Electrical Leads

Audience: Neurological healthcare professionals, physiatrists, and other physical medicine specialists
FDA has received reports in which patients with implanted deep brain stimulators (DBS) died after receiving diathermy therapy. Laboratory testing has shown that patients with any implanted metallic lead are at risk of serious injury when exposed to shortwave or microwave diathermy therapy. This is true even if the implanted device is not turned on, and even if the lead is no longer connected to an implanted system. If you are a physician who implants or monitors patients with leads or implanted systems with leads, explain to the patient what diathermy is, and stress that they should NOT receive shortwave or microwave diathermy therapy. If you are a health care professional who uses diathermy (shortwave or microwave) in your practice, be sure to ask the patient about possible implants before deciding to administer shortwave or microwave diathermy therapy.

[December 19, 2002 Public Health Notification - FDA] PDF Format

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Synagis (palivizumab)

Audience: Pediatricians, Pulmonologists, and other healthcare professionals
FDA and MedImmune revised the WARNINGS, OVERDOSAGE, and POST MARKETING EXPERIENCE sections of the label to provide clarification on the risk of anaphylaxis based on worldwide post-marketing experience. Very rare cases of anaphylaxis have been reported following re-exposure to Synagis. Rare severe acute hypersensitivity reactions have also been reported on initial exposure or re-exposure to palivizumab. The labeling was also revised to reflect that adverse events after a sixth or greater dose of Synagis are similar in character and frequency to those after the initial five doses.

[November 26, 2002 Letter - MedImmune] PDF Format

[October 2002 Full, Revised Label, changes highlighted - MedImmune]

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Zoloft (sertraline hydrochloride)

Audience: Psychiatrists and other healthcare professionals
At the request of the FDA, Pfizer issued an important drug warning letter announcing that they have added new information to the CONTRAINDICATIONS and PRECAUTIONS sections of the Zoloft labeling, contraindicating the concomitant use of pimozide with sertraline.

[November 2002 Letter - Pfizer] PDF Format

[November 2002 Full, Revised Label, changes highlighted - Pfizer]

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Injectable Drugs Prepared by Urgent Care Pharmacy

Audience: All healthcare professionals
The Food and Drug Administration (FDA) announced a nationwide alert concerning all injectable drugs prepared by Urgent Care Pharmacy of Spartanburg, South Carolina, based on the lack of assurance that their products are sterile. Non-sterility of injectable products can represent a serious hazard to health that could lead to life-threatening injuries and death. FDA inspection of Urgent Care's facility revealed the firm failed to have adequate controls to ensure necessary sterility, including the absence of appropriate testing for potency and sterility prior to distribution.

FDA is aware that Urgent Care has distributed the following injectable drugs to physicians, hospitals, clinics and consumers in Connecticut, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Mississippi, New Hampshire, North Carolina, South Carolina and Virginia: Baclofen, Betamethasone, Bimix 30:1, (Phentolamine mesylate/papaverine), Clonidine, Estradiol, Hydromorphone HCl, Fentanyl, methylprednisolone acetate, Morphine Sulfate/Bupivacaine, Papaverine HCl, Super Trimix (Papaverine HCl/phentolamine mesylate/prostaglandin), Testosterone cypionate, Testosterone/Estradiol.

[November 15, 2002 Talk Paper - FDA]

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Bextra (valdecoxib)

Audience: Rheumatologists and other healthcare professionals
FDA and Pharmacia/Pfizer strengthened the CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS sections of the prescribing information. In postmarketing experience, rare reports of hypersensitivity reactions (i.e, anaphylatic reactions and angioedema) and skin reactions, including cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, and erythema multiforme, have been received. These cases, some of which were serious/life threatening, have occured in patients with and without a history of allergic type reations to sulfonamides.

[November 2002 Letter - Pharmacia/Pfizer] PDF Format

[November 2002 Talk Paper - FDA]
[October 2002 Full, Revised Label, changes highlighted - Pharmacia/Pfizer]

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Cafergot (ergotamine tartrate and caffeine)

Audience: Neurologists and other healthcare professionals
FDA and Novartis strengthened the labeling, including a new BOXED WARNING and updates to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY sections of the prescribing information.

Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of Cafergot with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of Cafergot, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Because of the increased risk of serious vasospastic adverse events, concomitant use of these medications is contraindicated.

[October 2002 Letter - Novartis]
[July 2002 Full, Revised Label, changes highlighted - Novartis]

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Accutane (isotretinoin)

Audience: Dermatologists and other healthcare professionals
FDA and Roche revised the WARNINGS: Psychiatric Disorders, Boxed CONTRAINDICATIONS AND WARNINGS, DOSAGE AND ADMINISTRATION, and PRECAUTIONS: Drug Interactions sections of the prescribing information. Changes in pediatric labeling were made to the CLINICAL PHARMACOLOGY: Special Patient Populations: Pediatric Patients, WARNINGS: Skeletal: Bone Mineral Density, and PRECAUTIONS: Pediatric Use: sections.

Aggressive and/or violent behaviors have been added to the list of events that Accutane may cause, based on post-marketing safety reports. No mechanism of action has been established for these events. A new table has been added to clarify those circumstances where pregnancy tests and Accutane Qualification Stickers are applicable. Information specific to pediatric patients has been added based on the results of recent studies conducted in this patient population. A statement has been added regarding the long-term use of Accutane advising that Accutane be given at the recommended doses for no longer than the recommended duration. Prescribers were advised to exercise caution when systemic corticosteroids or phenytoin are used with Accutane.

[September 2002 Letter - Roche Laboratories]
[June 2002 Full, Revised Label, changes highlighted - Roche Laboratories]

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Bone Cement in Vertebroplasty and Kyphoplasty Procedures

Audience: Orthopedic specialists and other healthcare professionals
FDA notified healthcare professionals about complications related to the use of polymethylmethacrylate bone cement to treat osteoporotic compression fractures of the spine using surgical procedures known as vertebroplasty and kyphoplasty. Reported complications, such as soft tissue damage and nerve root pain and compression, are related specifically to the leakage of bone cement. Other reported complications include pulmonary embolism, respiratory and cardiac failure, and death.

[October 2002 Public Health Notification - FDA] Page UPDATED 4/1/2003, 5/7/2004

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Abbokinase (urokinase)

Audience: Cardiologists, Intensivists, and other healthcare professionals
FDA and Abbott announced the reintroduction of Abbokinase (urokinase) for use in the lysis of massive pulmonary emboli and pulmonary emboli accompanied by unstable hemodynamics. The WARNINGS section of the labeling has been strengthened to include post-marketing reports of anaphylaxis, other infusion reactions, and class information regarding the potential for cholesterol embolization. The ADVERSE REACTIONS section of the product labeling reflects the analysis of post-marketing safety data.

[October 10, 2002 Letter - Abbott Laboratories]
[October 2002 Full, Revised Label - Abbott Laboratories]

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Lunelle Monthly Contraceptive Injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension)

Audience: Pharmacists and Reproductive healthcare professionals
Pharmacia announced a voluntary recall of all Lunelle prefilled syringe lots on the market, due to a lack of assurance of full potency and possible risk of contraceptive failure. Lunelle packaged in vials is not affected by this recall. The affected lots were distributed in the United States, Puerto Rico and the U.S. Virgin Islands during 2002.

[October 10, 2002 Press Release - Pharmacia]
[October 10, 2002 Letter to Physicians - Pharmacia] PDF format

[October 10, 2002 Customer Notice to Pharmacists/Wholesalers - Pharmacia] PDF format

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Lariam (mefloquine hydrochloride)

Audience: Infectious disease and other healthcare professionals
FDA and Roche strengthened the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the label. Healthcare professionals were notified that Lariam is contraindicated for prophylaxis in patients with active depression, a recent history of depression, generalized anxiety disorder, psychosis, schizophrenia or other major psychiatric disorders, or with a history of convulsions. During prophylactic use, if psychiatric symptoms such as acute anxiety, depression, restlessness or confusion occur, these may be considered prodromal to a more serious event. In these cases, the drug must be discontinued and an alternative medication should be substituted.

[September, 2002 Letter to Physicians - Roche] PDF

or HTML format
[September, 2002 Letter to Pharmacists - Roche] PDF

or HTML format
[July, 2002 Full Revised Label with highlighted changes - Roche]

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Prempro/Premphase (conjugated estrogens/medroxyprogesterone acetate tablets)
Premarin (conjugated estrogens tablets, USP)

Audience: Reproductive healthcare professionals
FDA and Wyeth notified healthcare professionals about safety related labeling changes to the INDICATIONS and USAGE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE and ADMINISTRATION sections of the labels. The new safety information reflects new data, primarily from the Women's Health Initiative (WHI).

[August 28, 2002 Letter - Wyeth]

[August 13, 2002 FDA Statement on the Results of the Women's Health Initiative - FDA]

[August 2002 Premarin Full Revised Label - Wyeth]

275 kb pdf file
[August 2002 Premarin Patient Package Insert - Wyeth]

218 kb pdf file
[August 2002 Prempro/Premphase Full Revised Label - Wyeth]

465 kb pdf file
[August 2002 Prempro/Premphase Patient Package Insert - Wyeth]

219 kb pdf file

[Hormone Replacement Therapy -- Latest News - National Women's Health Information Center, HHS]

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Human Tissue Processed by Cryolife, Inc.

Audience: Surgeons and other healthcare professionals
FDA notified healthcare professionals that Cryolife, a human tissue-processing firm, was ordered to recall all distributed human allograft tissues, except allograft heart valves, that have been processed by Cryolife since October 3, 2001. This FDA recall order was issued after FDA discovered regulatory violations related to the processing of human tissue by Cryolife, documented fungal and bacterial contamination of Cryolife tissues, and found that Cryolife had not fully implemented adequate corrective actions.

[August 21, 2002 Public Health Notification - FDA]

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Norplant (levonorgestrel implants)

Audience: Gynecological healthcare professionals
Wyeth Pharmaceuticals announced that patients who have received the Norplant System and who were using backup contraception may safely stop using backup methods for contraception. Previously, patients had been advised to use backup contraception due to concerns about lower than expected release of the hormone levonorgestrel from several specific lots. Wyeth also announced that it does not plan to resume distribution or marketing of the six-capsule Norplant System (levonorgestrel implants), which provides contraception for five years.

[July 26, 2002 Talk Paper - FDA]
[July 26, 2002 Letter - Wyeth]

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Cochlear Implants

Audience: ENT Healthcare professionals
(UPDATE posted 7/31/2003) FDA notified healthcare providers about a recent study showing that children with cochlear implants are at greater risk of developing bacterial meningitis caused by Streptococcus pneumoniae than children in the general population. The study, conducted by FDA, the Centers for Disease Control (CDC) and others, was published in the July 31, 2003 issue of The New England Journal of Medicine.

(Posted July 24, 2002) FDA/CDRH notified healthcare professionals of a possible association between cochlear implants and the occurrence of bacterial meningitis. At least 25 cases of meningitis have been diagnosed worldwide in children and adults ranging in age from 21 months to 63 years who have undergone cochlear implantation for severe to profound deafness. A total of 9 known deaths resulted from these cases. Surveys of cochlear implant centers currently underway suggest there are additional, unreported, cases of meningitis in the cochlear implant population.

[July 24, 2002 Public Health Notification - FDA] PAGE UPDATED 7/31/2003

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PVC Devices Containing the Plasticizer DEHP

Audience: Hospital Risk Managers and other healthcare professionals
FDA's Center for Devices and Radiological Health posted a safety assessment of Di(2-ethylhexyl) phthalate (DEHP) released from polyvinyl chloride (PVC) medical devices. Healthcare professionals were advised of steps that can be taken to reduce the risk of exposure in certain populations.

[July, 2002 Public Health Notification - FDA / CDRH]

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Zonegran (zonisamide)

Audience: Neurologists, Pediatricians, and other healthcare professionals
FDA and Elan Pharmaceuticals added a bolded WARNING to inform healthcare professionals that pediatric patients appear to be at an increased risk for zonisamide-associated oligohidrosis and hyperthermia. Patients, especially pediatric patients, treated with Zonegran should be monitored closely for evidence of decreased sweating and increased body temperature, especially in warm or hot weather. The safety and effectiveness of zonisamide in pediatric patients have not been established. Zonisamide is not approved for use in pediatric patients.

[June, 2002 Letter - Elan Pharmaceuticals]

[June, 2002 Full, revised label and Patient Information leaflet - Elan Pharmaceuticals]

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Nettle Capsules (dietary supplement)

Audience: Healthcare professionals and consumers
Nature's Way Products, Inc. is recalling four lots of its 100 count Nature's Way brand Nettle capsules because the product contains excessive amounts of lead. People, especially children, who consume high levels of lead can suffer serious damage to their central nervous systems, sometimes leading to permanent neurological damage. The affected lots of the product were distributed nationwide primarily in health food retail establishments between October 2001 and May 2002. The lot numbers affected by this recall are 131237, 131238, 140738 and 215229.

[June 28, 2002 Press Release - Nature's Way Products]

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Camptosar (irinotecan hydrochloride)

Audience: Oncologists and others caring for patients with metastatic colorectal cancer
The prescribing information in the BOXED WARNING, WARNINGS, and PRECAUTIONS sections were revised to identify patients at higher risk of severe toxicity, to clarify dose modification guidelines, and to augment information about management of treatment-related toxicities, including severe and occasionally life-threatening diarrhea.

[May 10, 2002 Letter - Pharmacia]
[May 2002 Full, Revised Label - Pharmacia]

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Nolvadex [tamoxifen citrate]

Audience: Oncologists and other healthcare professionals caring for women with breast cancer
FDA and AstraZeneca added a boxed warning and strengthened the WARNINGS section of the label to inform healthcare professionals about new risk information of particular relevance to women with ductal carcinoma in situ [DCIS] and women at high risk for developing breast cancer and are receiving or considering Nolvadex therapy to reduce their risk of developing invasive breast cancer.

Serious, life-threatening or fatal events associated with Nolvadex in the risk reduction setting [women at high risk for cancer and women with DCIS] include endometrial cancer, uterine sarcoma, stroke, and pulmonary embolism. Healthcare providers should discuss the potential benefits versus the potential risks of these serious events with women considering Nolvadex to reduce their risk of developing breast cancer.

[May 15, 2002 Letter - AstraZeneca]
[May 16, 2002 Full, Revised Label - AstraZeneca]
[May 16, 2002 Patient Package Insert - AstraZeneca]

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Depakote / Depakene / Depacon (divalproex sodium / valproic acid / valproate sodium)

Audience: Neuropsychiatric healthcare professionals
FDA and Abbott strengthened the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the label for Depakote Tablets, Depakote ER Tablets, Depakote Sprinkle Capsules, Depakene Capsules and Syrup and Depacon for Injection. Healthcare professionals were informed that hyperammonemic encephalopathy, sometimes fatal, has been reported following initiation of valproate therapy in patients with urea cycle disorders [UCD], a group of uncommon genetic abnormalities. Patient criteria to consider in evaluation for UCD prior to initiation of valproate therapy are offered.

[June, 2002 Letter - Abbott]

[June, 2002 Full, Revised Label - Abbott]

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Seroquel (quetiapine fumarate)

Audience: Neuropsychiatric healthcare professionals and Pharmacists
AstraZeneca received reports of medication errors involving confusion between its atypical antipsychotic Seroquel (quetiapine fumarate), indicated for the treatment of schizophrenia, and Serzone (nefazodone hydrochloride), a product of Bristol-Myers Squibb, indicated for the treatment of depression. In addition to the similarity in names between Seroquel and Serzone, the overlapping strengths (100 mg and 200 mg), the dosage forms (tablets), the dosing interval (BID), and the fact that these two products were stocked close together in pharmacies were also critical in causing these errors.

[May 20, 2002 Letter - AstraZeneca]

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Procrit (epoetin alfa)

Audience: Oncologists and other healthcare professionals
Ortho Biotech Products, L.P., with the knowledge of FDA, notified pharmacists, health care providers, and wholesalers/distributors of counterfeit PROCRIT (epoetin alfa). Vials of PROCRIT labeled as 40,000 U/mL in four-pack boxes, lot number P002641 expiration date: 9/03 have been found to contain active ingredient that is approximately 20 times lower than would be expected for PROCRIT in 40,000 U/mL vials. Based on inventory and historic use patterns it is thought that all existing inventory of lot number P002641 may have been used. However, pharmacists and health care providers should check the product lot number and carefully examine all vials of PROCRIT before use. A brief description of the differences between the actual product and the counterfeit are provided in the letter. (posted 6/11/2002, 2:30 pm EDT)

UPDATE: In addition to lot number P002641, lot number P002384, expiration: 03/2003 has also been determined to be counterfeit product. Distinctions between this counterfeit lot and authentic PROCRIT are still being analyzed. Distinctions may not be the same as those identified in the Dear Healthcare Professional letter dated June 6, 2002. Thus, any product bearing this lot number in particular should be considered suspect. (posted 6/11/2002, 3:40 pm EDT)

UPDATE 2: In a further update to the June 6, 2002 letter to healthcare professionals, additional counterfeit product labeled as PROCRIT has been found bearing lot number P004582, expiration 02/2004. Authentic PROCRIT, lot number P004582 with expiration date February 2004, was last shipped from the Ortho Biotech distribution center on July 1, 2002. Based on historical usage patterns and inventory practices, it is likely that virtually all authentic PROCRIT with lot number P004582, has already been used. Any product bearing this lot number should be considered suspect. (posted 10/22/2002, 9:00 am EDT)

[June 6, 2002 Letter - Ortho Biotech] PDF Format
[June 7, 2002 Update - Ortho Biotech] PDF Format
[October 22, 2002 Update - Ortho Biotech]

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Lioresal Intrathecal (baclofen injection)

Audience: Neurologists, Neurosurgeons, and other healthcare professionals
Medtronic and FDA added a BOXED WARNING and strengthened the WARNINGS sections of the prescribing information of Lioresal Intrathecal, indicated for use in the management of severe spasticity of cerebral and spinal origin. The warnings inform healthcare professionals about rare cases of intrathecal baclofen withdrawal that can lead to life threatening sequelae and/or death in patients who abruptly discontinue therapy.

[April 2002 Letter - Medtronic] PDF Format

[April, 2002 Full, revised, highlighted label - Medtronic] PDF file

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Epogen (Epoetin alfa)

Audience: Pharmacists, distributors, and healthcare professionals
Amgen, with the knowledge of FDA, notified pharmacists and health care providers of counterfeit EPOGEN (epoetin alfa). EPOGEN 40,000 U/mL vials in ten-pack boxes, lot number P002970 expiration date: 7/03 has been found to contain active ingredient that is approximately 20 times lower than would be expected for EPOGEN in 40,000 U/mL vials. Pharmacists and health care providers should carefully examine all vials of EPOGEN before use. A brief description and pictures of the differences between the actual product and the counterfeit are provided.

[May 8, 2002 Letter - Amgen]

Past MedWatch Alerts:

[Feb 2001 Letter - Amgen] PDF Format

[March 2000 Letter - Amgen] PDF Format

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Serostim [somatropin (rDNA origin) for injection]

Audience: Pharmacists, distributors, and healthcare professionals
Serono, Inc. became aware of a counterfeit lot of Serostim [somatropin (rDNA origin) for injection]. The counterfeit material has been packaged to appear as drug product lot number S810-1A1. This is not a legitimate Serostim lot number. Preliminary information appears to indicate that the counterfeit material may have been distributed via the Internet. However, pharmacists should examine Serostim prior to dispensing to ensure that the package does not bear lot number S810-1A1.

[May 16, 2002 Press Release - Serono]

Past MedWatch Alerts:

[May 17, 2001 (Letter) - Serono, Inc.] PDF Format

[May 17, 2001 (Press Release) - Serono, Inc.] PDF Format

[January 23, 2001 (Press Release) - Serono, Inc.]

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Audience: Pharmacists, distributors, and healthcare professionals
GlaxoSmithKline announced that the company received four reports of suspect bottles containing 60 tablets of Combivir (lamivudine plus zidovudine) that actually contained another medicine, Ziagen (abacavir sulfate) Tablets. The company has determined that counterfeit labels for Combivir Tablets were placed on two bottles of Ziagen and labels on another two bottles are suspect. Both medicines are used as part of combination regimens to treat HIV infection. The incidents appear to be isolated and limited in scope. No injuries or adverse reactions have been reported. Company tests have shown no problems with the medicine itself.

[May 14, 2002 Letter to Healthcare Professionals - GlaxoSmithKline] PDF Format
[May 14, 2002 Letter to Pharmacists - GlaxoSmithKline] PDF Format
[May 10, 2002 Press Release - GlaxoSmithKline]
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Audience: Transplantation Health Care Professionals
Healthcare professionals were advised of the addition of a Boxed Warning and a strengthened Warning section in the labeling for PLAS+SD (Pooled Plasma,(Human) Solvent Detergent Treated). The new Boxed Warning contraindicates the use of PLAS+SD in patients undergoing liver transplant, patients with severe liver disease and known coagulopathies. In addition, the Warnings have been strengthened to advise that patients receiving large volumes of PLAS+SD be monitored for evidence of thrombosis, excessive bleeding, or exacerbation of DIC. PLAS+SD is manufactured by V.I. Technologies, Inc. and distributed by American National Red Cross, Blood Services.

[March 29, 2002 Dear Health Care Provider Letter - V.I. Technologies]
: Past MedWatch Alerts
[October 20, 2000 (Letter) - V. I. Technologies, Inc.] PDF Format
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Audience: Pharmacists, distributors, and healthcare professionals
3M notified healthcare professionals of a voluntary recall of Maxair Inhaler (pirbuterol acetate inhalation aerosol), press and breathe metered dose inhalers. The possibility exists that a Maxair press and breathe aerosol inhaler may stick intermittently and patients may not receive the expected puff of medication. This recall does not affect Maxair Autohaler (pirbuterol acetate inhalation aerosol), a breath-actuated metered dose inhaler.

[May 6, 2002 Recall Notice: Pharmacists - 3M]
[May 6, 2002 Recall Notice: Distributors - 3M]
[May 6, 2002 Recall Notice: Managed Care - 3M]
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Zyprexa (olanzapine): Audience: Pharmacists and Neuro-psychiatric healthcare professionals
Eli Lilly notified healthcare professionals of product tampering with Zyprexa, indicated for the treatment of schizophrenia and acute bipolar mania. In a small number of tampering incidents, pharmacists in the United States have found Zyprexa 10 and 15 mg bottles which have had all of the Zyprexa tablets removed and replaced with white tablets marked, "aspirin." The reports, thus far, have been confined to 60 count 10 mg and 15 mg bottles of Zyprexa. These incidents appear to be isolated and limited in scope and no injuries or adverse effects related to the tampering have been reported to date.

[May 4, 2002 Letter: Dear Healthcare Professional - Eli Lilly]
[May 4, 2002 Letter: Dear Pharmacist - Eli Lilly]
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Vioxx (rofecoxib): Audience: Healthcare professionals treating patients with osteoarthritis, rheumatoid arthritis, acute pain, and primary dysmenorrhea
FDA and Merck strengthened the WARNINGS, PRECAUTIONS, and CLINICAL STUDIES sections of Vioxx labeling to describe new cardiovascular and gastroenterological safety information. This information reflected the results of a prospective, active control study of Vioxx 50 mg daily versus naproxen 500 mg twice daily and from a placebo-controlled trials database. This information should be taken into consideration and caution should be exercised when Vioxx is used in patients with a medical history of ischemic heart disease.

[April 11, 2002 Talk Paper - FDA]
[April, 2002 Letter - Merck] 48 KB PDF file
[April, 2002 Full, revised, highlighted label - Merck] 2.4 MB PDF file
[April, 2002 Patient Package Insert, highlighted - Merck] 31 KB PDF file
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Heparin Sodium Injection, USP: Audience: Healthcare professionals
Wyeth Pharmaceuticals and ESI Lederle are voluntarily recalling ALL lots of Heparin Sodium Injection, USP (Porcine Derived) 1,000 units per mL, 1 mL DOSETTE ® Vial, 10 mL and 30 mL Multiple Dose Vials due to the presence of clear crystals containing an antioxidant compound from the vial rubber closures.

[May 1, 2002 Letter to Health Care Providers - Wyeth/ESI Lederle]
[May 1, 2002 Letter to Customers/Distributors - Wyeth/ESI Lederle]
[May 1, 2002 Drug Shortage Information - FDA]
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Thiazolidinediones [Actos (pioglitazone HCl), Avandia (rosiglitazone maleate)]: Audience: Primary care providers, endocrinologists, cardiologists and other healthcare professionals treating patients with type 2 diabetes mellitus
FDA approved changes to strengthen the labeling for Actos and Avandia. The WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections have been modified to more clearly describe the cardiovascular risks associated with the use of thiazolidinediones as monotherapy and in combination with other antidiabetic agents, particularly insulin.

[April 26, 2002 Summary - FDA]
[January 2002 Revised, highlighted label: Actos - Takeda]
[February 2001 Revised, highlighted label: Avandia - GSK]
[January 2002 Letter: Actos - Takeda]
[September 2001 Letter: Avandia - GSK]
[March 2001 Letter: Avandia - GSK]
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Rapamune (sirolimus): Audience: Transplantation Surgeons and other healthcare professionals
FDA notified healthcare professionals of a "Dear Health Care Provider" letter issued April 24, 2002 by Wyeth, sent to members of the American Society of Transplantation and The American Society of Transplant Surgeons. The letter informs clinicians of the risk of hepatic artery thrombosis, graft loss, and death associated with the use of Rapamune (sirolimus) in de novo liver transplantation.

[April 25, 2002 Letter - Wyeth]
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Immune Globulin Intravenous (Human) (IGIV): Audience: Healthcare professionals

(UPDATE Posted August 27, 2002): Certain information in the previously posted American Red Cross and Baxter letters (dated March 26, 2002 and posted April 22, 2002) may suggest that these products are more safe than another product on the market. At this time, there is no conclusive evidence to support this suggestion. Please refer to updated information below that is provided by the FDA as of August 27, 2002.

(Posted April 22, 2002) There have been post marketing reports describing serious thrombotic events (vascular occlusion) possibly associated with the administration of Immune Globulin Intravenous (Human) (IGIV). Precautionary statements, advising physicians to exercise caution in administering IGIV to patients with cardiovascular disease or previous thrombotic events, have been added to the labeling of both Baxter's Gammagard S/D and American Red Cross' Polygam S/D. The letters remind healthcare professionals of measures that may be important in reducing the risk of a thrombotic event.

[August 27, 2002 UPDATE - FDA]
[March 26, 2002 Letter - Baxter]
[March 26, 2002 Letter - American Red Cross]
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Albuterol Sulfate Solution for Inhalation (0.5%): Audience: ICU staff, Respiratory Therapists, and other healthcare professionals
FDA issued a Public Health Advisory notifying the medical community of two recent hospital outbreaks of lower respiratory tract colonization and infection with Burkholderia cepacia attributed to contaminated multi-dose bottles of albuterol sulfate. In most cases, colonization or infection occurred in the ICU setting, often in patients receiving mechanical ventilation. The advisory reminds healthcare professionals of measures that may be important in reducing the risk of contamination and subsequent outbreaks of infections. (The link below opens a new browser window with the advisory notice.)

[April 19, 2002 Public Health Advisory - FDA]
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Mifeprex (mifepristone): Audience: Obstetricians/Gynecologists and other healthcare professionals
The following is new safety information about Mifeprex (mifepristone):

[April 17, 2002 Letter - Danco]
[April 17, 2002 Q&A - FDA]
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Cytotec (misoprostol): Audience: Obstetricians/Gynecologists and other healthcare professionals
The following is new labeling information about Cytotec (misoprostol):

[May 21, 2002 Summary of Labeling Changes, Revised - FDA]
[April 17, 2002 Full Revised Label - Searle]
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Milk Based Powdered Infant Formulas Used in Neonatal Intensive Care Units: Audience: Pediatricians, Neonatologists
The FDA Center for Food Safety and Applied Nutrition (CFSAN) notified healthcare professionals about a growing body of information pertaining to Enterobacter sakazakii infections in neonates fed milk-based powdered infant formulas. In light of epidemiological findings, and the fact that powdered infant formulas are not commercially sterile products, FDA recommends that powdered infant formulas not be used in neonatal intensive care settings unless there is no alternative available. [The links below open new browser windows with the safety alerts.]

[April 12, 2002 Letter - FDA CFSAN]
[April 12, 2002 Talk Paper - FDA]
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Geodon (ziprasidone HCl): Audience: Healthcare Professionals caring for persons with schizophrenia
FDA and Pfizer strengthened the WARNINGS and CONTRAINDICATIONS sections of the Geodon prescribing information to inform healthcare professionals of the particular drugs or types of drugs that are contraindicated with Geodon.

[March, 2002 Letter - Pfizer]
[Feb 2002 Revised Label - Pfizer] Changes highlighted
[Feb 2002 Revised Patient Package Insert - Pfizer] Changes highlighted
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Lovenox (enoxaparin sodium)

Audience: Healthcare Professionals
FDA and Aventis strengthened the WARNINGS and PRECAUTIONS sections of the Lovenox prescribing information to inform healthcare professionals that the use of Lovenox Injection is not recommended for thromboprophylaxis in patients with prosthetic heart valves. New postmarketing safety information concerning congenital anomalies and non-teratogenic effects on pregnant women and fetuses are described.

[Feb 28, 2002 Letter - Aventis]
[July, 2001 Revised Label - Aventis] Changes highlighted
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Zerit (stavudine): Audience: Healthcare Professionals caring for persons with HIV
FDA and BMS notified healthcare providers caring for persons with HIV of the potential for lactic acidosis as a complication of therapy with Zerit (stavudine), d4T. Reports of occurrences of rapidly ascending neuromuscular weakness, mimicking the clinical presentation of Guillain-Barré syndrome (including respiratory failure), have been reported in HIV-infected patients receiving stavudine in combination with other antiretrovirals. Some cases were fatal. Most of the cases were reported in the setting of lactic acidosis or symptomatic hyperlactatemia.

The early signs and symptoms of clinical events associated with hyperlactatemia should receive careful attention because of the life-threatening potential of the most extreme manifestation, lactic acidosis syndrome (LAS). If motor weakness develops in a patient receiving stavudine, the drug should be discontinued.

[February 2002 Letter - BMS]
[January 2002 Revised Label - BMS] Changes highlighted
[January 2002 Revised Patient Package Insert - BMS] Changes highlighted
: Past MedWatch Alerts
[January 5, 2001 (Letter) - Bristol-Myers Squibb]
[January 5, 2001 (Letter) - Bristol-Myers Squibb] PDF Format
[January 5, 2001 (Talk Paper) - FDA]
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Kava-containing Dietary Supplements (Piper methysticum): Audience: Healthcare Professionals and Consumers
The FDA Center for Food Safety and Applied Nutrition (CFSAN) notified healthcare professionals and consumers of the potential risk of severe liver injury associated with the use of kava-containing dietary supplements. Supplements containing the herbal ingredient kava are promoted for relaxation (e.g., to relieve stress, anxiety, and tension), sleeplessness, menopausal symptoms and other uses. Kava-containing products have been associated with liver-related injuries, including hepatitis, cirrhosis, and liver failure. Given these reports, persons who have liver disease or liver problems, or persons who are taking drug products that can affect the liver, should consult a physician before using kava-containing supplements. [The links below open new browser windows with the CFSAN safety alert pages.]

[March 26, 2002 Consumer Advisory - FDA]
[March 26, 2002 Letter to Healthcare Professionals - FDA]
: Past FDA Alerts
[Dec 19, 2001 Letter to Healthcare Professionals - FDA]
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Olympus America Video Bronchoscopes: Audience: Hospital Administrators, Risk Managers, Pulmonologists
The FDA Center for Devices and Radiological Health notified healthcare professionals of a voluntary recall of Olympus America, Inc. bronchoscopes after a medical facility reported bacteria growth which possibly caused two illnesses. The bronchoscopes were distributed nationwide between June 5, 1997 and December 10, 2001.
Olympus issued a recall notification letter to hospitals and medical facilities about the suspect bronchoscopes on November 30, 2001, requesting they be returned to Olympus for modification. On February 27, 2002, Olympus issued a second recall notification letter to facilities that did not respond to their first letter. See the complete FDA/CDRH notification for additional information, including specific model numbers affected.

[March 20, 2002 Device Recall - FDA]
[March 20, 2002 FDA CDRH Recalls Page - FDA]
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A & A Medical/Rocket USA/Lifequest Ob/Gyn and Surgical Products: Audience: Hospital Administrators, Risk Managers, Department of Obstetrics and Gynecology
The FDA Center for Devices and Radiological Health notified healthcare professionals of a recall of all medical devices manufactured by A & A Medical, Inc. of Alpharetta, GA, labeled as sterile and shipped since 1999 nationwide because they may not have undergone sterilization. As a result, these devices could cause serious and possibly life-threatening infections. This firm manufactures many types of Ob/Gyn and surgical devices. The recall includes, but is not limited to curettes (flexible and rigid), uterine dilators, fetal blood samplers, and laparoscopy accessories. See the link below for a current list of known products affected by this recall.

[March 19, 2002 Safety Alert - FDA]
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Alpha Interferons: Intron A (Interferon alfa 2b, recombinant)
Rebetron Combination Therapy (Rebetrol (Ribavirin, USP) Capsules and Intron A)
Roferon-A (Interferon alfa-2a, recombinant)

Audience: Oncologists and other Healthcare professionals
Healthcare professionals are advised of important safety information for all alpha interferons. A BOXED WARNING has been added regarding the occurrence of neuropsychiatric, autoimmune, ischemic, and infectious disorders in patients taking alpha interferons; additional safety information and direction for patient monitoring is also provided in the WARNINGS section of the prescribing information.

[March 14, 2002 Letter - Schering] 134 kb PDF Format
[March 14, 2002 Revised Package Insert - Schering] 107 kb PDF Format
[March 14, 2002 Letter - Roche]
[March 14, 2002 Revised Package Insert - Roche] 303 kb PDF Format
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Versed Syrup (midazolam HCl) CIV: Audience: Anesthesiologists, pediatricians, and other healthcare professionals
Roche Laboratories is conducting a voluntary Class I drug recall of 118 mL (2mg/mL) bottle, lots U0009-50 and U0010-50, because of the potential presence of a crystalline precipitate of an insoluble complex of midazolam and saccharin inside the bottle. The presence of this precipitate causes a lack of uniformity in the product and may result in the administration of a super or sub-potent dose.

[March 1, 2002 Recall Notice - Roche] PDF Format
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Clozaril (clozapine): Audience: Psychiatrists, Pharmacists
FDA and Novartis have strengthened the BOXED WARNING and WARNINGS sections of the prescribing information (PI) for Clozaril (clozapine) as follows: (1) The previously existing BOXED WARNING has been relocated to the beginning of the PI and revised to advise health care providers of the association of myocarditis with clozapine therapy; (2) A subsection has been added to the WARNINGS section entitled "Myocarditis" to provide data and clozapine treatment guidelines related to this issue.

[Feb 20, 2002 Letter - Novartis] PDF Format
[Feb 20, 2002 Revised Package Insert - Novartis] 112 kb PDF Format
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Cytovene-IV (gancyclovir): Audience: Pharmacists, other healthcare professionals
Healthcare professionals advised of a critical shortage of Cytovene-IV, indicated for the treatment or prevention of cytomegalovirus (CMV) disease. This shortage in supply is expected to last through the second quarter of 2002. Roche urges physicians to explore alternative treatment therapies or management strategies for their patients. This temporary situation affects only the IV formulation of Cytovene.

UPDATED:
[March 13, 2002 Letter - Roche]

[Feb 13, 2002 Letter - Roche]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact Medwatch

PC SPES, SPES (BotanicLab): Audience: Urologists, Consumers
Consumers were warned to stop using the dietary supplement / herbal products PC SPES and SPES capsules because they contain undeclared prescription drug ingredients that could cause serious health effects if not taken under medical supervision. Laboratory analysis of the products by the California Department of Health Services found PC SPES contains warfarin and SPES contains alprazolam. Warfarin and alprazolam are available only by prescription and sold either by their generic names or the trade names, Coumadin and Xanax. PC SPES and SPES are respectively marketed "for prostate health" and strengthening the immune system. BotanicLab, the manufacturer of the products, voluntarily recalled PC SPES and SPES nationwide.

[June 05, 2002 Press Release -CA Dept of Health Services]
[Feb 08, 2002 Press Release -CA Dept of Health Services]
[Feb 08, 2002 Recall Notice - BotanicLab] link no longer available

UPDATED September 20, 2002; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact Medwatch

Serzone (nefazodone HCL): Audience: Psychiatrists, Pharmacists
FDA and BMS added a Black Box Warning and strengthened the WARNINGS, CONTRAINDICATIONS, and PRECAUTIONS sections of the label for Serzone, an antidepressant drug. Rare cases of liver failure leading to transplant and/or death in patients have been reported. A new Patient Package Insert is provided in the product packaging.

[Jan 09, 2002 Letter -Bristol-Myers Squibb] PDF Format
[Jan 09, 2002 Full Revised Label] PDF Format (Changes highlighted)
[Jan 09, 2002 Patient Package Insert] PDF Format; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact Medwatch

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2002 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements

Last updated: April 1, 2003

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