• Defective Drug Side Effects

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The U.S. Food and Drug Administration has just sent an “approvable” letter for the diabetes drug muraglitazar (Pargluva), but a consumer group and two clinical trial experts have told the agency it should not be approved.

According to watchdog group Public Citizen, Pargluva increases the risk of death, congestive heart failure and other adverse events. In a letter sent to the acting commissioner of the FDA, Andrew Von Eschenbach, the authors questioned the benefits of the drug, saying safer alternative are already available.

Even though studies showed an increase in congestive heart failure, weight gain and cancer associated with Pargluva, the FDA advisory committee voted to approve the drug. On Oct. 18, the FDA notified companies Bristol-Myers and Merck that the drug was “approvable,” pending additional studies, but just two days later another analysis showing the drug''s risks was published.

Cardiologists Steven Nissen and Eric Topol, from the Cleveland Clinic, found that an analysis of the drugmaker''s data, in addition to FDA documents, showed an increased risk of death, heart attack or stroke. The consumer group calls on the FDA to seek more information about the drug''s potential risks before approving it, especially given the “relatively safe and effective drug treatments” that already exist for diabetes.