Scientists at the Cleveland Clinic Foundation have raised a red flag about so-called COX-2 inhibitors, suggesting that these popular painkillers slightly increase a person’s risk of heart attack.
The drugs, such as rofecoxib and celecoxib, are widely prescribed because they seem less likely to trigger ulcers and bleeding in the stomach than are aspirin and other nonsteroidal anti-inflammatory drugs.
Preliminary reports to the Food and Drug Administration of heart problems associated with COX-2 inhibitors led Eric J. Topol and his coworkers to reexamine studies by research groups that monitored people taking the drugs over several months.
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Topol and his colleagues calculated that in the studies, heart attacks occurred at an annualized rate of 0.8 percent in people taking celecoxib and 0.74 percent of people taking rofecoxib. The researchers contrast these rates with the 0.52 percent annualized heart attack rate among healthy people receiving placebos in trials testing aspirin’s heart benefits, Topol says.
In the Aug. 22/29 Journal of the American Medical Association, Topol says, “There were disturbing trends no matter how we looked at the data.” He adds, “This is not a whopping effect, but . . . since COX-2 inhibitors are used by hundreds of thousands of people each year, this is not trivial.”
The FDA hasn’t yet decided whether to require a label on COX-2 inhibitors warning of potential heart problems. The firms making the drugs argue that past studies weren’t designed to look for heart attacks, and current trials show no increases as yet.
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The only way to resolve the issue, says Topol, is to study a large number of people, especially those at risk for heart disease, who are taking COX-2 inhibitors. The researchers would need to focus on heart problems from the very beginning.