Pfizer Wants COX-2 Back on Market

Pharmacy Times, Volume 0,0

The chief executive officer (CEO) of one ofAmerica's pharmaceutical giants says hehopes to be able to work with the FDA to getthe painkiller Bextra back on the market. PfizerInc halted all sales of the cyclooxygenase-2 (COX-2) inhibitor in April due to concernsabout its potential harmful side effects. Anotherdrug in the same class, Merck's Vioxx, wastaken off the market in the fall of 2004 byMerck because of an increased risk of heartattack.

Hank McKinnell, CEO of Pfizer, stated thatthe FDA had seen unpredictable skin reactionsfrom Bextra but had not seen "increasedcardiovascular risk."The FDA did, however,receive 7 reports of people dying from severeskin reactions after taking Bextra. In April, theFDA placed a "black-box"warning for risk ofcardiovascular events on Celebrex, anotherCOX-2 inhibitor manufactured by Pfizer, andrecommended that Bextra be pulled off themarket as well. If Bextra is reintroduced, however,it will be for a limited purpose only, andpatients may have to sign a consent form.