Bextra (Valdecoxib) - FDA Alerts

FDA Alerts related to Bextra (Valdecoxib)

FDA Alert [4/7/2005]:

FDA has requested that Pfizer voluntarily withdraw Bextra from the United States market.  Pfizer has agreed to suspend sales and marketing of Bextra in the United States, pending further discussion with the Agency.   At this time, the Agency 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.