Doubts Escalate Over Painkillers

RESPONDING TO TROUBLING studies involving the COX-2 inhibitor class of drugs, FDA has released a public health advisory recommending limited use of COX-2 agents. Another class of painkillers, nonselective nonsteroidal anti-inflammatory drugs (NSAIDs), is also raising red flags. FDA took action following the halt of a study involving Pfizer's COX-2 drug Celebrex (celecoxib). The 2,000-patient trial, conducted by the National Cancer Institute, was exploring how Celebrex might help prevent colon cancer. It was stopped because of an increased risk of both fatal and nonfatal cardiovascular events associated with the drug. In a statement, Pfizer CEO Hank McKinnell called the trial results "new" and "unexpected." Patients taking 400mg twice a day had 3.4 times the risk of cardiovascular problems, while 200mg twice-daily doses increased the risk 2.5-fold. Recommended doses for the treatment of rheumatoid arthritis are 200 to 400mg a day. A separate study on Celebrex sponsored by ...