Bextra - Overview - FindLaw

Bextra, the trade name of the generic drug valdecoxib, was approved by the U.S. Food and Drug Administration (FDA) on November 16, 2001. Its intended use was to relieve symptoms of osteoarthritis and rheumatoid arthritis in adults. On April 7, 2005, the Food and Drug Administration (FDA) announced that it has asked Pfizer, Inc. to voluntarily withdraw Bextra from the U.S. market. Pfizer agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the FDA.

In information provided to healthcare professionals, the FDA stated that it "has concluded that the overall risk versus benefit profile of Bextra is unfavorable.  This conclusion is based on the potential increased risk for serious cardiovascular (CV) adverse events, which appears to be a class effect of non-steroidal anti-inflammatory drugs (NSAIDs) (excluding aspirin), an increased risk of serious skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme) compared to other NSAIDs, and the fact that Bextra has not been shown to offer any unique advantages over the other available NSAIDs."

Bextra: Getting Legal Help

While all medications have certain, anticipated side effects, a drug manufacturer has a duty to make its pharmaceutical products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs.  If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings or the unreasonably dangerous nature of the drug, under a legal theory called "product liability."