You Are Here > Home > Clinical Tools and Services > Pharmacy > Drug Warnings / Recalls
Drug Recalls / Warnings

    CenterWatch, the Clinical Trials Listing Service, maintains a current listing of Drugs Approved by the FDA, by year. Drugs are listed in one of twenty clinical categories, i.e., Neurology, Oncology, etc.

    MedWatch, the Federal Drug Administration's (FDA) Medical Products Reporting and Safety Information Program (800-FDA-1088, or MedWatch, HF-2, 5600 Fishers Lane, Rockville, MD, 20852-9787), serves both healthier professionals and the medical product-using public. This service provides important and timely clinical information about safety issues involving medical products, including prescription and over-the-counter drugs, biologics, dietary supplements, and medical devices.

    Medical product safety alerts, recalls, withdrawals, and important labeling changes are disseminated to the medical community and the general public through this web site.

MedWatch also allows healthcare professionals and consumers to report serious problems that they suspect are associated with the drugs and medical devices they prescribe, dispense, or use. Reporting can be done on line, by phone (1-800-FDA-1088), by facsimile (1-800-FDA-0178), or by submitting the MedWatch 3500 form by mail.

Medical Product Safety Information includes;

  • Recalls, Withdrawals, & Safety Issues
  • Searchable FDA Safety Databases
  • The Special Nutritionals Adverse Event Monitoring System
  • Adverse event reports associated with use of dietary supplements, infant formulas, and medical foods.
  • Medical Device Reporting Data Files
  • Manufacturer and User Facility Device Experience Database
  • Safety Alerts for Drugs, Biologics, Devices, and Dietary Supplements
  • Drug Safety Labeling Changes
  • FDA Enforcement Report (Recalls and Legal Actions)
  • Information on all FDA-classified recalls
  • Center for Biologics Evaluation and Research (CBER)
  • Articles / Free CME include;
  • Managing the Risks from Medical Product Use: Creating a Risk Management Framework
  • FDA Consumer Magazine
  • Minimizing Medical Product Errors
  • Food & Drug Interactions

 

Summary of Warning Letters from Pharmaceutical Manufacturers

Clozaril
(clozapine tablets)
Revisions to the BOXED WARNING, WARNINGS, CONTRAINDICATIONS, PRECAUTIONS (Information for Patients and Pharmacokinetic-Related Interactions subsections), and ADVERSE REACTIONS (Postmarketing Clinical Experience subsection) sections of the prescribing information for Clozaril (clozapine) tablets. Recommendations from the FDA's Psychopharmacological Drugs Advisory Committee regarding the white blood cell monitoring schedule, required for all clozapine users, has resulted in modification in the monitoring schedule. Additional labeling changes address safety issues related to dementia-related psychosis, parlytic ileus, hypercholesterolemia and pharmacokinetic interaction with citalopram. From the FDA Medwatch: more

Serzone
(nefazodone hydrochloride)
Changes to Indications and Usage: . . . the prescriber should consider the risk of hepatic failure associated with Serzone treatment (see warnings). In many cases , this would lead to the conclusion that other drugs should be tried first.
Changes to Dosage and Administration: When deiding among the alternative treatments available for depression, the prescriger should consider the risk of hepatic failure associated with Serzone treatment (see warnings).
Also addition to warnings requirding the need for careful monitoring for risk of suicide.
For more information: Bristol-Myers Squibb Company, P.O. Box 4500, Princeton, NJ, 08543-4500. jk,6-18-04

Desyrel
(Trazodone Hydrochloride Tablets)
Label modifications in the Clinical Pharmacology section discuss the metabolizum of the active metabolite by the cytochrome P450 3A4 (CYP3A4), and the inhibition by ketoconazole, ritonavir, indinavir, and carbamazzepine, with resultant increase in serum levels and half-life of trazodone. Similar changes were made to the Precautions section.
For more information: Bristol-Myers Squibb Company, P.O. Box 4500, Princeton, NJ, 08543-4500. jk, 4-23-04

Sporanox
(itraconazole)
Labeling change: Black Box Warning: "Drug Interactions: Coadministration of cisapride, pimozide, quinidine, dofetilide, or levacetylmethadol (levomethadyl) with Sporanox, a potent cytochrome P450 3A4 isoenzyme system (CYP3A4) inhibitor, may increase plasma concentrations of drugs metabolized by this pathway. Serious cardiovascular events, including QT prolongation, torsades de pointes, ventricular tachycardia, cardiac arrest, and/or sudden death have occurred in patients using . . . (sic: these drugs) . . . Further information is provided in changes to Contraindications, Warnings, and Precautions, including:
1. Ergot alkaloids are contraindicated.
2. Halofantrine should be used with caution if coadimistered with Sproanox.
3. ...cases of congenital abnormalities have been reported. . .
4. Caution with renal impairment.
5. Sporanox is not recommended with severely neutropenic patients/
For more information: 800-526-7736, Janssen Pharmaceutica Products, L.P.
jk, 4-2-04.

Serevent
(salmeterol xinafoate)
Labeling change based on the Smart Safety Study, a 28 week safety study comparing Serevent and placebo in treating asthma. An interim analysis of on 28,858 patients showed a higher but not statistically signifcant number of asthma related life-threatening experiences, including deaths, in the Serevent group. There was a statistically significant greater number of primary events and asthma related events, including deaths, in African Americans treated with Serevent. New recommendations and advice for managing asthma patients were provided. GlaxoSmithKline, 888-825-5249, www.gsk.com, 11/03, jk

Prempro
(0.625 mg., conjugated equine estrogen, 2.5 mg., medroxyprogesterone acetate) May, 2003
Labeling change based on the Women's Health Initiative Memory Study (WHIMS, a subsidy of the Women's Health Initiative (WHI). This substudy followed 4,532 women, 65 years or older, for an average of 4.1 years. It found an increased relative risk of developing probable dementia compared to women taking a placebo. The labeling change is for the warnings and adverse events sections of the product labeling.
For more information, Wyeth, 800-934-5556.

Activella
(estradiol/norethindrone acetate tablets) March 2003
Because of the Women's Health Initiative study using Prempro and the increased incidence of adverse effects, Pharmacia recommends the use of progestins in combination with estrogens should be monitored closely, should be limited to the shortest duration consistent with treatment goals and risks for he individual woman, and should be periodically evaluated.
For more information, Pharmacia, 100 Route 206 North, Peapack, NJ 07977.

Prempro
(conjugated estrogens/medroxyprogesterone acetate tablets), Premphase (conjugated estrogens/medroxyprogesterone acetate tablets), and Premarin (conjugated estrogens tablets, USP). January, 2003
For More Information: Wyeth Pharmaceuticals, 800-934-5556, www.prempro.com.
 New boxed warnings stating that combination therapies should not be used for prevention of cardiovascular disease. For estrogen only therapies, the same language plus the increased risk of endometrial cancer if used without a progestin. Also new risk information based on the Women's Health Initiative.

Zoloft
(sertraline hydrochloride).November, 2002.
For more information: Pfizer, Inc, 212-573-2323. FDA has changed the prescribing information because of the results of a recent study. Zoloft and Pimozide should not be administered together

Provera
(Combination conjugated equine estrogens (CEE)) November, 2002.
More Information: 800-323-4204, Pharmacia's Medical and Drug Information Unit. In light of the Women's Health Initiative Study, one component of Prempro, Provera, should be assumed to carry the same increased risks of cardiovascular events, breast cancer, and venous thromboembolic events associated with the use of Prempro. Use of Provera in conjunction with estrogens should be monitored closely, should be limited to the shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically evaluated.

Bextra
(valdecoxib tablets)November 13, 2002
Changes to product labeling: postmarking experience revels rare, spontaneous hypersensitivity reactions (i.e., anaphylactic reactions and angiodema). Also skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiforme. Some of these patients had a history of allergic-type reactions to sulfonamides, while others didn't.

OxyContin
July 18, 2001
See also: www.purduepharma.com, 888-726-7535
1. New Warnings: Tablets are to swallowed whole, and are not to be broken, chewed, or crushed. Doing so may cause absorption of potentially fatal dose of the drug.
2. New Indications: Moderate to severe pain for continuous analgesia for an extended time; Not for use as a prn analgesic; Treatment should be individualized; Postoperative use only if patient was taking before the surgery. Purdue Pharma, L.P., 1 Stamford Forum, Stamford, CT 06901-3431

Lamisil
May, 2001.
Summery:
1. Rare Hepatic Failure,
2. Possible drug interactions with CYP2D6 mediated compounds,
3. Confusion with other drugs, especially Lamictal (lamotrigene, an antiepileptic.
Novartis Pharmaceuticals Corporation, 59 Route 10, East hanover, NJ 07936-1080

Lotronex
(alosetron), November, 2000
Summery: Discontinuing marketing and implement a withdrawal because of reports of ischemic colitis with rare reports of death.
GlaxoWellcome, Five Moree Drive, PO Box 13398, Research Triangle Park, NC, 27709-3398

This listing is informational only, and is not meant to be definitive or comprehensive. The summary is provided as a service only, and the full text of the letter or warning should be consulted.

 


HOME     SEARCH     CONTACT US      EXIT