Drug Reports Give Consumers a Headache

With Vioxx (search) off the market and heart-risk questions being raised about Celebrex (search) and Aleve (search), what is someone who needs pain relief to do?

That's a question vexing many Americans, and the answers aren't immediately clear.

These are drugs widely used for arthritis, a condition that can require long-term treatment.

Yet Dr. Sandra Kweder of the Food and Drug Administration (search) says patients who routinely take naproxen, the generic name for Aleve, should follow the drug package instructions carefully, including directions not to take it for more than 10 days consecutively.

While the voluntary withdrawal of Vioxx on Sept. 30 led to questions about two other drugs in its class, Celebrex and Bextra, the report that indicated naproxen also might pose a heart risk was unexpected.

"Aleve sort of hit us by surprise," said Dr. Peter Bruno of the New York University School of Medicine.

Naproxen, sold both over the counter as Aleve and in stronger prescription versions, has been on the market for almost three decades. It is a different class of drug than the other three in question.

It was under investigation by the National Institutes of Health for possible benefits in Alzheimer's patients when researchers found a higher risk of heart attack and stroke than in patients given placebos. The trial was halted, NIH announced Monday.

Bayer HealthCare, which makes Aleve, said Tuesday it has not seen the research data but plans to cooperate with federal authorities.

"In the meantime, we are in agreement with the FDA's recommendations that Aleve can be used safely as directed for pain relief and that consumers should not take the product for longer than 10 days unless directed to do so by a physician," the company said in a statement.

One thing most experts tend to agree on is a need for patients who take any of the drugs in question to discuss the risks and benefits with their physicians to decide what's best.

"I think it is premature to make any judgment," about naproxen, said Dr. John H. Klippel, president of the Arthritis Foundation.

Celebrex and other drugs known as Cox-2 inhibitors are important drugs being used to treat an important problem, Klippel said. "This is an opportunity for people taking Cox-2 inhibitors to have a discussion with their doctor about medications and other approaches to treat arthritis," he said.

Bruno noted that the reported cardiovascular problems have occurred in people who took the drugs over long periods of time. Both Aleve and the Cox-2 drugs remain in the body for extended periods, remaining in contact with body tissues a long time, which may bring part of the damaging effect, he added.

"I don't think for the average person, taking these drugs for a short period of time, there's a reason to panic with any of these drugs," said Bruno, who also is the New York Yankees' internist.

"When you've got pain, the safest thing is to just take an over-the-counter medicine, taking an over-the-counter dosage. That doesn't mean taking like five times the recommended dose," he said.

"And you take it for short periods of time, less than 10 days, intermittently, and I find it very hard to believe that people would have bad effects," Bruno said.

Dr. Paul Lindsey, head of rheumatology at the Ochsner Clinic Foundation Hospital in Baton Rouge, La., stressed that the studies need to be put in perspective.

All the problems occurred in long-term studies, and the medications have proven safe in short-term trials of six weeks to six months, he said.

"My advice is patients who have serious heart disease should question their doctor about whether they need to stay on these medicines indefinitely," he said. "For people who use these medicines intermittently now, or have little risk of heart trouble, I don't think they need to be alarmed."

Dr. Mark Fendrick, a University of Michigan physician who helped develop published guidelines for patients and doctors on choosing alternative painkillers, urged that people taking either Celebrex or Bextra "immediately contact their doctors" about whether to continue.

"Long-term use of any nonsteroidal anti-inflammatory medication can be dangerous and requires supervision by a medical professional," Fendrick said. "Anyone taking over-the-counter NSAIDs for chronic pain or inflammation should consult their doctor. People taking these drugs for occasional, intermittent pain should be careful not to take more than the recommended dose."