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Another Vioxx In The U.S. Drug Pipeline?

The same researchers at the Cleveland Clinic who first uncovered the lethal side effects of Vioxx may have saved even more lives with their latest discovery: A new diabetes drug on the brink of FDA approval appears to double a patient's risk of heart attack, stroke and death.

Scientists analyzed data on some 2,400 patients who took muraglitazar (Pargulva), a new drug that reduces blood fats and sugars, and about 1,400 who took a similar drug, pioglitazone (Actos), versus a placebo. During the study, 35 patients taking muraglitazar experienced a heart attack or stroke or died. And, when heart attacks and mini-strokes were considered alone, a patient's risk of a dangerous side-effect jumped by a factor of three.

This study (free text link below) was rushed to the Journal of American Medical Association's Web site for good reason: Two days before the study was released, the FDA found muraglitazar to be an approvable drug, although the agency asked drugmaker Bristol-Myers to address the drug's heart risks.

An FDA advisory committee ruled 8-1 to recommend muraglitazar for approval last month, yet didn't cite the drug's cardiac risks as significant... Now, do you have a better idea why I believe the FDA, as it's currently structured, is completely unable to adequately protect you?

Journal of the American Medical Association October 20, 2005 Free Full Text Article

USA Today October 21, 2005

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