Bextra Withdrawn From Market

Yael Waknine

Disclosures

April 07, 2005

April 7, 2005 — At the request of the U.S. Food and Drug Administration (FDA), Pfizer, Inc, has agreed to suspend sales and marketing of valdecoxib (Bextra) pending further discussions with the agency. The FDA claims that the drug's overall risks outweigh the potential benefits, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program.

The decision follows a joint public meeting of the FDA’s Arthritis Drugs/Drug Safety and Risk Management Advisory committees, held in February to review safety data compiled from clinical trials and postmarketing reports.

According to the FDA, the request was based on a lack of adequate data regarding the cardiovascular (CV) safety of long-term valdecoxib use and the increased risk of adverse CV events observed in trials of valdecoxib in coronary artery bypass postsurgical patients that may be relevant to chronic use.

In addition, the FDA has received reports of serious and potentially life-threatening skin reactions causing some fatalities in patients receiving valdecoxib therapy. The risk of these reactions is considered unpredictable; the reactions have occurred with both short- and long-term use and in patients with and without a history of sulfa allergy.

Patients receiving valdecoxib therapy are advised to contact their healthcare providers to arrange for alternative therapy. The FDA notes that valdecoxib has not been associated with any advantages compared with other nonsteroidal anti-inflammatory drugs (NSAIDs).

As a result of the meeting, the FDA has also asked manufacturers to revise the labeling for all prescription NSAIDs, including celecoxib (Celebrex, made by Pfizer, Inc), to include stronger warnings on the increased risk of CV events and potentially life-threatening gastrointestinal (GI) bleeding associated with their use. Medication guides are to be dispensed with each prescription to inform patients of the potential CV and GI risks and to advise on safe use of the drug.

Labels for over-the-counter NSAIDs will also include more specific information concerning CV and GI risks, and they will warn of potential skin reactions. The labeling revisions do not apply to aspirin because it has been shown in clinical trials to reduce the risk of serious adverse CV events in certain populations.

Additional information, including a list of affected NSAIDs, is available on the FDA's Web site at http://www.fda.gov/cder/drug/infopage/cox2/default.htm. Information can also be obtained by calling 1-888-INFO-FDA (888-463-6332).

Adverse events related to use of valdecoxib and other NSAIDs can be reported to the FDA's MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD

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