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Last updated on February 13, 2012 at 17:08 EST

Pain Relief Elusive After Drug Scare ; Doctors Are Urging Patients to Consult With Their Physicians Before Stopping Any Medications.

December 23, 2004

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

That’s a question vexing many Americans, and the answers aren’t immediately clear. These drugs are widely used for arthritis, a condition that can require long-term treatment.

Dr. Sandra Kweder of the Food and Drug Administration 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.

For Janie Skertich, a staff pharmacist at Gate City Pharmacy Inc. in Greensboro, any decision about naproxen has to be “a very individualized decision, depending on what their health history is.”

Naproxen, sold both over the counter as Aleve and in stronger prescription versions, has been on the market for almost three decades.

Skertich said, “I still believe it’s a good product and it’s helped a lot of people. And I would encourage people to talk to their doctor before they stop taking it.”

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.

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 a significant 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, 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.

“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.

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.”