PargluvaTM on Hold

The new diabetes drug Pargluva^TM that received 8-to-1 backing by an FDA panel last month has hit a stumbling block on its way to full FDA approval.

Concerns regarding its cardiovascular risk, noted in my previous post, have been revisited by independent researchers at the Cleveland Clinic. Their analysis was hastily published yesterday in an online article by the Journal of the American Medical Association (JAMA). The researchers warn that Pargluva^TM could double the risk for heart attack, stroke, and death.

Catherine DeAngelis, JAMA's editor in chief, likened the safety concerns and their possible fallout with the situation surrounding Merck's arthritis drug Vioxx.

The Cleveland Clinic recommends that longer-term trials be done to address cardiovascular issues before the drug goes to market.

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For JAMA's article:
Effect of Muraglitazar on Death and Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes Mellitus

Some News Links:
Questions Raised About Proposed Diabetes Drug (NYTs)

UPDATE 2-Medical journal cites risks for diabetes drug (Reuters)

Study: New Diabetes Pill Can Double Risk of Death, Heart Attack, Stroke (Fox)