updated 9/12/2006 6:27:19 PM ET 2006-09-12T22:27:19

Worried that your painkiller could trigger a heart attack or dangerous stomach bleeding?

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New reports on painkiller risks, based on reviews of dozens of studies including hundreds of thousands of patients, indicate most patients should try naproxen, an older anti-inflammatory drug best known under the brand Aleve.

Experts say it doesn’t raise heart attack or stroke risk — a major worry for older people — and naproxen is inexpensive because generic versions have been around for years. Available over the counter, it’s taken by millions of Americans.

The drawback is that like most painkillers, it can irritate the stomach, so doctors say some people may also need to take one of the newer acid reflux drugs.

“I do think we should start with naproxen in the vast majority of cases,” said Dr. Steven Nissen, head of cardiology at the Cleveland Clinic and president of the American College of Cardiology. “It’s about balancing the cardiovascular and gastrointestinal risk.”

The new reports were published Tuesday ahead of schedule on the Web site of the Journal of the American Medical Association because of their public health implications. They will be published in the Oct. 4 issue of the journal.

New concerns about other painkillers
Along with the good news about naproxen, the two studies raise new concerns about a few painkillers, particularly diclofenac, which has been on the market since 1988. The commonly used anti-inflammatory drug, also sold as Voltaren and Cataflam, carries as high a risk of heart attack or stroke as Vioxx.

The new analyses also provide even more evidence of the dangers to the heart and kidneys posed by Vioxx, which was pulled from the market two years ago.

The latest findings should help patients and doctors confused about painkiller safety since news began unfolding about the risks of Vioxx, Bextra and other nonsteroidal anti-inflammatory drugs.

“If something has helped you in the past and you haven’t experienced an adverse reaction with it, stay with that drug,” advises Larry Sasich, a pharmacy school instructor and consultant to Public Citizen’s Health Research Group.

Based on a study that group did with Hartford Medical School, patients should wait seven years before trying a new drug, Sasich said. By then, safety problems usually become clear. Patients also should review the Food and Drug Administration guide to NSAIDS on its Web site or ask a pharmacist.

Those especially worried about safety could try pain ointments first, said Dr. Richard Jermyn, director of the University Pain Care Center in Stratford, N.J. If they don’t help, he suggests Tylenol, then naproxen or ibuprofen before resorting to Celebrex, a Pfizer Inc. drug in the same class as Merck & Co.’s Vioxx. He urges patients on any of those drugs to get liver and kidney function tests every six months.

The heart risks from diclofenac were reported by researchers at the University of Newcastle in Australia. That report recommends regulators review whether diclofenac should stay on the market.

The FDA said in a written response that none of the new information warrants a change in its regulations on NSAIDs.

The same report also showed increased cardiovascular risk with another old but less-used drug, indomethacin, and “probably” the same with the newer Mobic, Dr. David J. Graham, an FDA drug safety expert critical of the agency’s handling of Vioxx concerns, wrote in an editorial.

Mobic, made by Boehringer Ingelheim Corp., is widely used in Australia and many U.S. patients were switched to it amid worries that all the cox-2 inhibitors — the class that includes Vioxx and Celebrex — increased cardiac risk.

Graham, who was not writing on behalf of FDA, noted that even Celebrex — considered a good alternative drug by some experts — increased heart risks at high doses. He said the federal government and insurers should study the cardiac safety of the prescription he favors: naproxen plus an acid-reflux drug.

The second review, by researchers at Harvard’s medical and public health schools and Brigham and Women’s Hospital, covered only the cox-2 drugs and focused on less-publicized problems, including abnormal heart rhythms and kidney-related disorders. It found those risks are not raised by Celebrex or other cox-2 drugs sold in foreign countries, but Vioxx increased the risk of kidney problems about 50 percent and nearly tripled the risk of potentially deadly heart rhythms.

That could add to the more than 16,000 lawsuits already filed against Merck. In addition, the review of cardiovascular studies found that Vioxx increased heart attack and stroke risk right away — not after 18 months’ use as Merck has argued in defending against lawsuits — and that the drug was particularly dangerous at doses above 25 milligrams per day.

Merck said in a statement that data from previous studies contradict “the interpretations published today” in JAMA that short-term Vioxx use raises heart attack and stroke risk.

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