FDA advisers to assess safety of arthritis drugs

Sunday, February 13, 2005

WASHINGTON -- Vioxx and other pain-relieving drugs have given many people with chronic pain the chance to resume normal lives. But an increase in heart attacks among users of the popular arthritis drug led the manufacturer to pull it from the market and has cast a shadow over similar medications.

For three days beginning Wednesday, two advisory groups to the Food and Drug Administration will hear from regulators, doctors, pharmaceutical companies, researchers and the public in an effort to understand what went wrong -- and what needs to be done now.

Merck & Co.'s Vioxx and two similar drugs -- Pfizer Inc.'s Celebrex and Bextra, both of which remain on the market -- are among a new class called Cox-2 inhibitors used widely to treat arthritis.

Merck pulled Vioxx from the market on Sept. 30 when a long-term trial found an increase in heart attacks and strokes among patients taking Vioxx.

The withdrawal of Vioxx also raised questions about the safety of Celebrex and Bextra.

A 1999 study of Alzheimer's patients taking Celebrex found that the patients had four times the risk of heart problems. In November a preliminary study indicated Bextra more than doubled the risk of heart attack and stroke among heart disease patients.

While awaiting findings of the advisory committees, the FDA has urged physicians and patients to use caution with any painkiller.

Pfizer contends that definitive conclusions cannot be drawn from that study.

In December, a different study linked Celebrex to increased cardiovascular problems. Pfizer's president of worldwide development, Dr. Joseph Feczko, said the results in that study were not consistent with a "large body of data" the company had collected.

In November a preliminary study discussed at the American Heart Association's annual meeting indicated Bextra more than doubled the risk of heart attack and stroke among heart disease patients.

Pfizer said those findings were "unsubstantiated conclusions" that had not been subjected to independent scientific review. But the company advised regulators that it will add to the Bextra packaging a warning of a potentially fatal skin reaction linked to the drug.

The FDA has received a request from the consumer group Public Citizen to order Celebrex and Bextra from the market, which the agency is reviewing.

While awaiting findings of the advisory committees, the FDA has urged physicians and patients to use caution with any painkiller.

Dr. John K. Jenkins, the FDA's director of new drugs, said even such popular over-the-counter products as Aleve, ibuprofen and aspirin should not be used longer than 10 days without consulting a doctor.

Naproxen, a popular painkiller sold as Aleve and Naprosyn, has been implicated in heart problems in a National Institutes of Health study.

"This is a rapidly evolving area," Jenkins said.

Painkillers such as aspirin can carry a serious risk of stomach and intestinal bleeding, Jenkins said, and doctors must balance this with the potential heart risk of some of the other drugs.


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