New Diabetes Drug Shows Signs of Health Dangers

By Elizabeth Rhein

Published on November 02, 2005

Researchers from the Cleveland Clinic conducted an independent study of the drug, in which the FDA's data was reanalyzed. Their findings show an alarming risk of cardiovascular problems, strokes, and death in patients taking Pargluva.

Previous to the completion of the independent study, the FDA had told drugmaker Bristol-Meyers Squib that pending some additional safety information, Pargluva would be considered "approvable." At no point did they ask for a study detailing the drug's impact on the cardiovascular system.

After recovering from the sting of failed drugs such as Vioxx and Rezulin, the FDA is especially vulnerable to outside accusations that new medications are being hurried through the approval process. Critics say that the government agency needs to focus on drug safety at a much earlier stage than it does currently.

A statement put forth by Bristol-Meyers Squibb states that the company intents to pursue in-depth discussions with the FDA to determine the best course of action in light of the study findings.

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