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Statement on FDA’s Announcement About Use of Celecoxib (Celebrex) and Valdecoxib (Bextra)

Sidney M. Wolfe, M.D., Director, Public Citizen’s Health Research Group

The FDA is once again siding with a large pharmaceutical company, in this case Pfizer, in refusing to ban the two Pfizer COX-2 selective drugs Celebrex and Bextra. Further, despite a lack of evidence of a significant benefit of these drugs compared to older pain/arthritis drugs as far as protecting the gastrointestinal tract, the FDA recommended today that:

Patients who are at a high risk of gastrointestinal (GI) bleeding, have a history of intolerance to non-selective NSAIDs, or are not doing well on non-selective NSAIDs may be appropriate candidates for Cox-2 selective agents.

Although there was evidence that Vioxx, now off the market because of significantly increased risks of heart attacks and strokes, was protective to the gastrointestinal tract compared one older drug, there is no such credible evidence for either Celebrex or Bextra.

Both Celebrex and Bextra are doomed drugs that are in the twilight of their existence. Breathing extra live into them is surely beneficial to Pfizer executives and stockholders but is a step backward for an agency that is supposed to be part of the Public Health Service.