April 08, 2005

painkiller Bextra off market

Medical professionals expressed surprise and concern at the Food and Drug Administration request for pharmaceutical giant Pfizer to withdraw its blockbuster painkiller Bextra from the market citing concerns that the drug can cause a dangerous skin condition and is at least as dangerous to the heart as other painkillers. The F.D.A. also said that it would require Celebrex, another Pfizer painkiller in the same class of drugs, to carry a prominent warning of possible heart risks. That warning could hinder Pfizer's plans to revive Celebrex's flagging sales reports New York Times.

"The FDA is taking away doctor-patient decision-making," said Dr. Gerard Varlotta, director of sports rehabilitation at New York University Medical Center in New York City. "I think they could allow Bextra to be sold with warnings and it would then be a doctor-patient decision. We have warning labels on everything, even plastic bags."

Pfizer said in a statement the company "respectfully disagrees" with FDA's position but would suspend sales pending further discussions.

"What we're asking for, is that the labeling make it more explicit, but none of these risks are new," said Dr. Steven K. Galson, acting director of FDA's Center for Drug Evaluation and Research.

"We used to just put people on these drugs for life and not think about it, but we can no longer commit them to lifelong therapy with impunity," said Dr. Thalia Segal, a pain specialist at New York University. "We have to use these medications judiciously and follow people more closely. We have to rely on a much more individualized approach."

Vioxx, Bextra and Celebrex are all non-steroidal anti-inflammatory drugs that work by inhibiting the cox-2 enzyme, which is involved with pain and inflammation. The drugs have been popular because they offer pain relief without the stomach problems caused by older arthritis medicines. The agency took more severe action against Bextra, one of two pain relievers on the market that selectively block cox-2 enzymes because studies showed that the drug also heightened the risk of a potentially deadly skin disease. Cox-2 enzymes can promote inflammation.

Merck withdrew Vioxx after studies showed increased risks of cardiovascular problems among patients taking the drug. In December, FDA upgraded warning labels on Bextra to reflect the increased risk of both heart problems and serious skin reactions.

The combination of those risk factors, set against the lack of compensating benefits, led FDA to call for Bextra's removal, said Dr. John Jenkins, director of the FDA's office of new drugs.

Of all the traditional nonsteroidal anti-inflammatory drugs, only aspirin, which has special anticlotting effects that benefit the heart, has been spared the black-box warning. Unlike other older nonsteroidals, aspirin does not cause blood platelets to stick together, lowering the likelihood of plaque formation and heart attacks. Celebrex, on the other hand, is considered to be less harmful to the heart than Bextra because it has less effect on cox-2 enzymes.

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