FDA Statement on the Halting of a Clinical Trial of the Cox-2 Inhibitor Celebrex

“While we have not seen all available data on Celebrex, these findings are similar to recent results from a study of Vioxx (rofecoxib), another drug in the same class as Celebrex. Vioxx was recently voluntarily withdrawn by Merck. Another drug in this class, Bextra (valdecoxib) has shown an increased risk for CV events in patients after heart surgery. Bextra and Celebrex are the only two selective COX-2 agents currently on the U.S. market.

Physicians should consider this evolving information in evaluating the risks and benefits of Celebrex in individual patients. FDA advises evaluating alternative therapy. At this time, if physicians determine that continued use is appropriate for individual patients, FDA advises the use of the lowest effective dose of Celebrex . . .

Because similar long-term studies of other products in the class of non-steroidal anti-inflammatory drugs (NSAIDS), other than

Cox-2 inhibitors have not been done, it is not known whether other NSAIDS pose a similar risk.”

Not encouraging for Pfizer. Also, consider that last statement – maybe they should do a similar trial looking at simple ibuprofen.