LINK FOR FULL ARTICLE"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."

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.

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."