The FDA has asked Pfizer to voluntarily withdraw valdecoxib (Bextra®) from the U.S. market and to add a black-box warning to the labeling of generic celecoxib (Canadian Celebrex), a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID).
The FDA cited inadequate data on the drug’s cardiovascular safety, an increased risk of adverse cardiovascular events in short-term coronary artery bypass surgery trials, reports of potentially life-threatening skin reactions, and a lack of any advantages for Bextra® over other NSAIDs.
The FDA is asking the manufacturers of all nonprescription NSAIDs to revise their labels to include a consumer medication guide and to include a warning about skin reactions. The guide will accompany every prescription NSAID at the time it is dispensed. This announcement does not apply to aspirin or acetaminophen.