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FDA Assessing Safety of Arthritis Drugs

Feb 16, 2005 | AP

With Vioxx off the market because of links to heart problems and concerns growing about the related drugs Celebrex and Bextra, a pair of Food and Drug Administration advisory committees are assessing the safety of the popular painkillers.

These prescription drugs, called Cox-2 inhibitors, have become popular for people with chronic pain, particularly since they help patients avoid the stomach and intestinal problems than can result from many commonly used over-the-counter pain medications.

But a long-term study that showed an increase in heart attacks and strokes among people using Vioxx prompted its maker, Merck & Co., to halt sales of the drug Sept. 30.

Since then, similar questions have been raised about Pfizer Inc.'s Celebrex and Bextra, though both remain on sale.

The editor of a leading medical journal questioned whether patients should continue using the drugs.

"Because there are well-established options for treatment of all the approved indications for these drugs, it is reasonable to ask whether the use of the drugs can now be justified," Dr. Jeffrey M. Drazen, editor of the New England Journal of Medicine, said in an editorial published online Tuesday.

In calling the advisory committee hearing Wednesday, the FDA's Center for Drug Evaluation and Research noted that many consumers and scientists have asked whether any Cox-2 drugs should be allowed to remain on sale.

"What is your view? Is there a patient population for whom the risk is warranted, given the known potential for benefit?" the agency asked the advisory committees on arthritis and drug safety and risk management.

The Health and Human Services Department announced Tuesday that the FDA will establish a new Drug Safety Oversight Board to monitor medicines once they're on the market and will update physicians and patients with emerging information on risks and benefits.

Dr. Mark Fendrick, an internal medicine specialist at the University of Michigan, said the decision on using the drugs "should be considered one of competing risk and benefits."

"It comes down to the individual and his or her clinician to assess the risks and make the best informed choice," Fendrick said. "Until we know for sure about the cardiological safety of the Cox-2 inhibitors, I believe they should be limited to those individuals who have a risk of stomach injury and those who are at low risk for cardiac problems."

People who have a heart risk or who take aspirin to protect the heart should consider a traditional painkiller, he said.

Many people who take the Cox-2 drugs to avoid stomach problems also take aspirin to protect the heart, he noted, which cancels the gastrointestinal protection of the Cox-2 drugs.

The advisers will also be trying to determine what it is about these drugs that could cause an increase in heart problems.

On Monday, a paper in the journal Archives of Internal Medicine reported on a new analysis that indicates Cox-2 inhibitors raise blood pressure more than conventional pain medications.

A second possibility is that Vioxx directly affects endothelial cells, which line the heart and blood vessels.

A 1999 study of Alzheimer's patients taking Celebrex indicated the patients had four times the risk of heart problems. 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.

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.


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