Due to urging from the FDA, Pfizer has agreed to put the sales and marketing of its cyclo-oxygenase-2 inhibitor valdecoxib (BextraTM) on hold in the US and Europe pending further discussion. Reasons sited by the FDA for removal included a lack of adequate data on the cardiovascular safety of long-term use of valdecoxib, increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trials, and reports of serious and potentially life-threatening skin reactions. Additionally, significant advantage of valdecoxib over other nonsteroidal anti-inflammatory drugs (NSAIDs) has not been demonstrated.
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