The controversy over pain relievers’ cardiovascular risks highlights the need to empower the U.S. Food and Drug Administration to demand drug companies conduct further tests on already-approved drugs, according to a prominent cardiologist.
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In an editorial in the Journal of the American Medical Association, Dr. Eric J. Topol of the Cleveland Clinic also questioned the wisdom of allowing consumer advertising for “lifestyle medications that have no capability of preserving life or preventing major events such as” a heart attack or stroke.
In late September, Merck & Co. pulled its pain reliever Vioxx from the market because it doubled patients’ risk of heart attacks and strokes. Since then, studies have also linked Pfizer Inc.’s Bextra and Celebrex to higher risk of cardiovascular problems. All three drugs are in a class known as Cox-2 inhibitors.
But Topol and others have noted that there were early signs of cardiovascular problems with such drugs but that no trials were ever conducted specifically to assess their cardiovascular risks.
“Had coxib trials been conducted five years ago in patients with established cardiovascular disease, when the benefit and risk were indeterminate, clinicians would have quickly learned the risk and potentially avoided a major cardiovascular calamity,” writes Topol, an early Vioxx critic, in an editorial that was published Tuesday on JAMA’s Web site. The editorial will be published in the journal next month.
Topol said that “providing more authority to the FDA to shape and require the execution of vital trials is perhaps the most important lesson from the coxibs.” The FDA doesn’t have the authority to compel such trials after it has approved a product.
Topol also wrote that the combination of mass consumer advertising of a medicines with questionable safety profiles can’t be tolerated and that “unbridled promotion” of the Cox-2s “exacerbated the public health problem.”
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