Drugmaker Pfizer Inc. is in talks with regulators over a likely change to arthritis drug Bextras label to carry a strict warning alerting doctors of the risk of a potentially deadly skin reaction.
Bextra, a Pfizer pain drug that received a sales boost when Merck's Vioxx was pulled from the market, will probably be tagged with the most prominent type of safety warning used by the FDA.
Pfizer warned doctors that one of its best-selling painkillers, Bextra, might increase the risk of heart attack or stroke in coronary artery bypass surgery patients.
The FDA is preventing an agency scientist from presenting the largest, most up-to-date study of popular painkillers like Bextra, Celebrex and Vioxx.
