Doctors say avoid Pfizer’s Bextra - medical journal

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Doctors writing in a prominent medical journal on Friday recommended that physicians stop prescribing Pfizer Inc.’s Bextra painkiller, just as a large study found the drug maker’s sister drug, Celebrex, doubled risk of heart attacks.

Both drugs are members of the so-called COX-2 inhibitor class of painkillers, which recently gained notoriety when Merck & Co. Inc. withdrew Vioxx in September after a study found it doubled the risk of heart attack and stroke.

A letter by three top doctors published in The New England Journal of Medicine said that in light of Vioxx and negative signs on Bextra, Bextra should be avoided.

“We believe the doubts raised about the safety of valdecoxib (Bextra), constitute a potential imminent hazard to public health” and thus they should be prescribed only in “extraordinary circumstances,” editorial writers at The New England Journal of Medicine wrote in an issue dated Dec. 23, but released early.

Earlier on Friday, Pfizer, the world’s No. 1 drug maker, said a government-sponsored trial of Celebrex was halted after patients taking the medicine had more than twice as many heart attacks as patients taking a placebo.

The developments are rekindling debate over the merits and safety of the entire class of painkiller drugs, doctors interviewed by Reuters said.

“I’m a cardiologist and I take note of these findings from this trial, which say there is harm, and I am supposed to ‘do no harm,”’ said Marc Pfeffer, a doctor at Brigham and Women’s Hospital in Boston, who advised researchers on the Celebrex study on the heart effects.

Pfeffer and other top doctors said they will not be prescribing the drugs for their patients.

NO TO COX-2s

Pfizer, for its part, has aggressively defended Bextra and Celebrex since Vioxx’s withdrawal and questions about safety arose. A spokesman at Pfizer said the company had not seen the medical journal letter and could not comment.

The company has put out at least four press releases defending the safety of Bextra and Celebrex since the Sept. 30 recall of Vioxx by Merck.

Chief Executive Hank McKinnell again defended the drug class and said in a Friday television interview that there should not be a rush to judgment because of the findings.

The authors of The New England Journal of Medicine letter are doctors at the Vanderbilt University School of Medicine. They said they made the recommendation in light of the long lag time between when evidence emerged on Vioxx and its withdrawal, coupled with two negative studies suggesting Bextra boosts heart problems in bypass patients by a factor of three.

Older cheaper painkillers such as aspirin are as effective as the COX-2s, but can upset some stomachs.

Jonathan Kay, associate clinical professor at Harvard Medical School and a rheumatologist at Massachusetts General Hospital, uses painkillers as a cornerstone treatment for his rheumatoid arthritis patients.

He said the key advantage of using COX-2 inhibitors—protecting the stomach in patients with gastrointestinal problems—can be avoided by prescribing a separate medication to prevent stomach upset.

“This data about Celebrex certainly raises enough concern that all physicians should be very cautious,” Kay said.

SOURCE: New England Journal of Medicine, December 23, 2004.

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