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F.D.A. Urges Doctors to Limit Prescriptions for Two Painkillers 2004-12-24
By Gardiner Harris

F.D.A. Urges Doctors to Limit Prescriptions for Two Painkillers

By GARDINER HARRIS and ALEX BERENSON

Published: December 24, 2004

WASHINGTON, Dec. 23 - The Food and Drug Administration recommended Thursday that doctors limit prescriptions for the popular pain pills Celebrex and Bextra because recent studies have suggested that they may increase the risk of heart attack and stroke.

The agency's advisory did not ban prescriptions of the drugs for any group of patients, instead simply telling doctors to use their best judgment in light of those studies. Indeed, it said patients who were at high risk of gastrointestinal bleeding or had done poorly on other pain pills "may be appropriate candidates" for Celebrex and Bextra.

Still, doctors may "decide to use other agents instead of these agents until we can sort out more clearly what the data show," said Dr. John Jenkins, director of the agency's Office of New Drugs.

The advisory also urged consumers to pay close attention to the directions for over-the-counter painkillers and to follow them carefully. But with regard to Celebrex and Bextra, it was less forceful than one issued Tuesday by the Medicines and Healthcare Products Regulatory Agency in Britain, which advised doctors to switch arthritic patients with heart disease to other medicines "as soon as is convenient."

The F.D.A. said it would continue to examine recent studies of the drugs to determine whether more regulatory action was needed. It plans to convene a meeting of independent experts in February and ask them to sort through the studies and make recommendations.

Pfizer Inc., the maker of Celebrex and Bextra, issued a statement Thursday saying this advisory group was "the appropriate panel 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."

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, a consumer watchdog, criticized the drug agency for "once again siding with a large pharmaceutical company, in this case Pfizer, in refusing to ban" Celebrex and Bextra.

Worries about the two drugs increased after Merck & Company withdrew its similar pill, Vioxx, from the market in September because a study had shown that extended use of it doubled the risk of heart attack and stroke.

In the days after Vioxx was pulled, Pfizer maintained that it had no evidence that either Celebrex or Bextra carried similar risks. But on Nov. 9, the company released the results of a study that it had been examining since before the Vioxx withdrawal. That research showed that Bextra more than doubled the incidence of heart attack and stroke among patients who had recently undergone heart surgery. Still, Pfizer declared that both Celebrex and Bextra were safe, pointing to other studies showing no such risk.

Then, last week, the National Institutes of Health announced that it was ending a study using Celebrex because high doses of it more than tripled the risk of heart attacks and stroke among patients; moderate doses more than doubled those risks. In the wake of that study, Pfizer has said it has no plans to withdraw either Celebrex or Bextra.

Dr. Samin Sharma, director of cardiac catheterization at Mount Sinai Hospital in New York City, said he was continuing to allow his heart patients who suffer from arthritic pain to take Celebrex, in low doses.

"I'm not telling anyone to stop it," Dr. Sharma said. "It can make a big difference for these patients. They're crippled without it."

Dr. James O'Donnell, an associate pharmacy professor at Rush University in Chicago, said patients concerned about the heart risks of Celebrex could switch to an older drug like ibuprofen along with a medicine to reduce the risk of upset stomach and stomach bleeding.

Dr. O'Donnell said Prilosec, which is available over the counter, would reduce the risk of stomach bleeding from drugs like ibuprofen, the generic name for Advil. Cytotec, available by prescription, is even more effective, although pregnant women should not use it because it can induce miscarriages.

For patients who cannot tolerate older drugs like ibuprofen because of their effect on the stomach, alternatives include Tylenol and Ultram, a nonaddictive painkiller available only by prescription, said Dr. Robin Hamill-Ruth, director of the pain management center at the University of Virginia. Unfortunately, many patients find that they do not get much relief from either of those drugs, she said.

Dr. Hamill-Ruth encouraged patients to continue taking over-the-counter medicines like ibuprofen. For most people with moderate arthritis, those drugs improve mobility and quality of life at relatively low risk of stomach problems, she said.

"You have to look at the risk-benefit piece of this," she said. "Chances are the risk is fairly little."

Other, nondrug alternatives include glucosamine and chondroitin, supplements that have been shown in some clinical trials to increase the formation of new cartilage without serious side effects, Dr. Hamill-Ruth said. Even heat pads or ice pads, she said, can offer some relief.

"Heat and ice, for heaven's sake, and regular stretching are great for arthritis," she said.

Celebrex, Bextra and Vioxx are among a class of medicines called cox-2 inhibitors, which were originally developed to be easier on the stomach than older drugs like Advil and Naprosyn. None cure pain any better than the older medicines, and Celebrex and Bextra have never proved to be any better at preventing ulcers than the older pills.


 
 
 
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