Pfizer Removes Valdecoxib From the Market

Due to urging from the FDA, Pfizer has agreed to put the sales and marketing of its cyclo-oxygenase-2 inhibitor valdecoxib (Bextra^TM) 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.

For additional information on cardiovascular risk of selective COX-2 inhibitors, see earlier news summary.

All information contained within the Johns Hopkins Arthritis Center website is intended for educational purposes only. Physicians and other health care professionals are encouraged to consult other sources and confirm the information contained within this site. Consumers should never disregard medical advice or delay in seeking it because of something they may have read on this website.