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FDA Urges Limited Use of Pfizer's Celebrex, Bextra

Posted Oct 23 2008 2:25pm
WASHINGTON - U.S. health officials on Thursday called on doctors to limit prescribing Pfizer Inc. painkillers Celebrex and Bextra in light of recent evidence that they may increase the risk of heart attack and stroke.

The Food and Drug Administration described its health advisory as an interim step. Any additional action would require further evaluation of sometimes conflicting data and public discussion at an advisory meeting set for February.

"The actions that we're recommending in the advisory are for more limited prescribing than would currently be included in the approved labeling for these products," John Jenkins, director of the FDA's Office of New Drugs, told reporters on a conference call.

The FDA said doctors should weigh the benefits and risks for individual patients. The agency also ordered a review of all prevention studies involving Celebrex and Bextra.

Individuals vulnerable to gastric bleeding associated with older painkillers may still be appropriate candidates for COX-2 drugs that include Celebrex and Bextra, the FDA said.

Pfizer said it was providing the FDA with extensive safety and effectiveness data for Celebrex and Bextra.

"The U.S. FDA Advisory Committee Hearing in February is the appropriate forum for a thorough review of all available data evaluating the benefits and risks of medicines used by millions of Americans to treat arthritis and joint pain," Pfizer said.

The FDA action follows a recent series of warnings of increased heart attacks and strokes connected to both over-the-counter and prescription painkillers.

Merck & Co. Inc. withdrew its arthritis drug Vioxx in September after a study showed the painkiller doubled the chances of heart attack and stroke.

Pfizer has kept its similar medicine, Celebrex, on the market, but has agreed to suspend consumer advertising. Pfizer has also placed a note on its Bextra painkiller that warns of increased risk in patients who have just had heart bypass surgery.

And health officials warned on Monday of a risk of heart attack and stroke in over-the-counter naproxen, sold as a generic and as several brand names, including Bayer AG's Aleve, and as Roche AG's Naprosyn.

NEWER DRUGS

Vioxx, Celebrex and Bextra are in a newer class of painkillers known as COX-2 inhibitors, designed to avoid the gastric bleeding associated with older drugs like aspirin.

But critics of the FDA said the only COX-2 drug showing clear gastric protection was the now-withdrawn Vioxx.

"Both Celebrex and Bextra are doomed drugs that are in the twilight of their existence," predicted Dr Sidney Wolfe, a frequent critic of FDA's drug safety monitoring and director of the consumer group Public Citizen's Health Research Group.

But Dr. Gregg Fonarow, professor of cardiovascular medicine at the University of California, Los Angeles said the FDA was right to be cautious in judging COX-2s. "It shouldn't be overlooked that there are individuals who are at high risk for internal bleeding," Fonarow told Reuters.

The naproxen warning surprised some experts who had thought the painkiller might help protect the heart by preventing blood clots, in much the way aspirin does.

A now-canceled National Institutes of Health (NIH) study of anti-inflammatory drugs in patients at risk for Alzheimer's disease uncovered the higher heart risk for naproxen.

Celebrex showed no significant increase in heart risk in the Alzheimer's trial but had raised concerns in another NIH trial testing Celebrex for cancer prevention.

COX-2 inhibitors are a subset of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which include aspirin, naproxen and ibuprofen.

The FDA advised consumers taking non-prescription NSAIDs to strictly follow instructions on the label and consult a doctor if they need to take them for more than 10 days.

Pfizer stock fell initially on news of the FDA advisory but rebounded to close up 12 cents to $26.07 a share on the New York Stock Exchange.
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