Pfizer Wants COX-2 Back on Market

JULY 01, 2005

The chief executive officer (CEO) of one of America's pharmaceutical giants says he hopes to be able to work with the FDA to get the painkiller Bextra back on the market. Pfizer Inc halted all sales of the cyclooxygenase- 2 (COX-2) inhibitor in April due to concerns about its potential harmful side effects. Another drug in the same class, Merck's Vioxx, was taken off the market in the fall of 2004 by Merck because of an increased risk of heart attack.

Hank McKinnell, CEO of Pfizer, stated that the FDA had seen unpredictable skin reactions from Bextra but had not seen "increased cardiovascular risk."The FDA did, however, receive 7 reports of people dying from severe skin reactions after taking Bextra. In April, the FDA placed a "black-box"warning for risk of cardiovascular events on Celebrex, another COX-2 inhibitor manufactured by Pfizer, and recommended that Bextra be pulled off the market as well. If Bextra is reintroduced, however, it will be for a limited purpose only, and patients may have to sign a consent form.