Researchers call old pain reliever as risky as Vioxx

The Baltimore Sun

The widely used pain reliever diclofenac poses the same cardiovascular risk as the withdrawn drug Vioxx and should not be used by people with heart disease or high blood pressure, researchers reported yesterday.

Diclofenac, an older drug sold as Cataflam or Voltaren, increased patients' chance of heart attack by 40 percent, according to an analysis of 23 clinical studies, the same risk observed in patients who took low doses of Vioxx.

The report was released early by the Journal of the American Medical Association because of its health implications.

Diclofenac, which has been sold for more than 30 years, is available only by prescription in the United States and is not widely used here. But it is sold over-the-counter elsewhere and ranks among the most popular pain relievers in the world.

But now, "there is no reason to keep it on the market," said Dr. Curt D. Furberg of Wake Forest University, who was not involved in the study. "It clearly increases the risk of heart attack, and patients have other choices."

Dr. David Henry of the University of Newcastle in Australia, an author of the study, said diclofenac poses little risk for younger people with no signs of heart disease but, given the availability of other drugs, "I would say it has no saving graces."

The FDA said in a statement that it did not consider the findings on diclofenac conclusive, but the study warranted further review.

The report contained reassuring findings about some other pain relievers. Naproxen, sold over the counter as Aleve and by prescription as Naprosyn, showed no cardiac risk.

Celebrex was safe at recommended doses of 200 milligrams or less. Henry said he could not give Celebrex "a clean bill of health" because other studies have detected increased cardiovascular risks at doses of 400 milligrams or greater.

"Naproxen looks best from a cardiovascular point of view," he said. "It is an old, cheap generic drug, and we would tend to favor it."

Because naproxen can cause ulcers and bleeding, patients should take the drug with medicines used to treat ulcers and control stomach acid, such as Prilosec, Henry said.

With his colleague, Dr. Patricia McGettigan, Henry analyzed the results of clinical studies of eight pain relievers involving more than 1.2 million patients. All drugs in the analysis belonged to a class of medications known as nonsteroidal anti-inflammatory drugs, or NSAIDs.

About 30 million people worldwide take an NSAID daily for pain and inflammation.

Two drugs included in the analysis, Vioxx and Celebrex, belong to a subset of NSAIDs known as Cox-2 inhibitors, which were developed as stomach-friendly alternatives to older NSAIDs, such as ibuprofen and naproxen.

The Cox-2 drugs were tremendous moneymakers because they were expensive and widely used.

But in September 2004, Merck & Co. removed Vioxx from the market after it was found to cause heart attacks in some patients.

The latest study confirmed the cardiovascular risks of Vioxx, concluding that it was not safe at any dose.

The chance of heart attack was 33 percent higher at the 25-milligram dose - in the range of risk associated with diclofenac - and more than double at doses above 25 milligrams.

Denise Gellene writes for the Los Angeles Times.

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