More Pain for Painkillers

Heart risks complicate the decision to take some common drugs

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The search for a good painkiller has always been frustrating. Opioids like Vicodin work great--except they're addictive. Acetaminophen (Tylenol) is powerful--but it can wreck your liver. Even aspirin, with all its known heart benefits, can lead to internal bleeding. Now there's more painful news for people suffering from conditions like severe arthritis: researchers have confirmed heart risks for those taking large doses of two popular nonsteroidal anti-inflammatory drugs (NSAIDs).

A University of Oxford study reports that the NSAIDs diclofenac and ibuprofen have heart risks similar to those of NSAIDs that have already been banned. Although these risks were known in both ibuprofen and diclofenac, the study made clear that the danger increases significantly if a patient already has heart problems.

The Oxford study found that for every 1,000 patients taking high-dose prescription diclofenac or ibuprofen (150 mg diclofenac and 2,400 mg ibuprofen daily vs. a typical 50- and 400-mg dose) there are three additional heart attacks, four heart-failure events and one death. That difference may seem small, but it becomes significant in proportion to a person's existing underlying heart-attack risk without the drugs. "If someone has twice the average risk, perhaps because they smoke, then the extra risk for heart attack doubles [again]," says lead researcher Colin Baigent.

Problem is, NSAIDs are some of the most commonly used and effective drugs worldwide--and the options have dwindled.

Among the more targeted NSAIDs known as COX-2 inhibitor drugs, Celebrex is the only one still on the U.S. market. In 2004, Merck voluntarily withdrew Vioxx, even though the drug was profoundly helpful to some patients; in 2005 the U.S. Food and Drug Administration (FDA) asked Pfizer to remove the drug Bextra for similar reasons. Dr. John Hardin, vice president of research for the Arthritis Foundation, says his pain patients still lament the removal of Vioxx.

There are some drugs under development that lack these health issues. Researchers are looking at mPGES-1 inhibitors, or gene-deletion drugs, which so far have shown fewer heart risks in mice than COX-2 inhibitors. Scientists are also studying Naproxcinod, which is less likely to elevate blood pressure. It is awaiting FDA approval.