Physicians warn FDA against approving Pargluva for diabetes

The FDA today released a study showing that the experimental diabetes drug Pargluva from Bristol-Myers Squibb and Merck doubled the risk of heart attacks and strokes. The drug developers won an approvable letter from the FDA's expert panel earlier this week but were asked to provide additional safety data before gaining final approval. Researchers at the Cleveland Clinic advised the FDA not to approve the drug, citing the elevated risk of cardiovascular disease.

"This agent should not be approved to treat diabetes based on laboratory end points until safety is documented," wrote doctors Steven E. Nissen, Kathy Wolski and Eric J. Topol. "If our analysis is correct," added Dr. Nissen, "then this could be a public health catastrophe of the magnitude of what we saw with Vioxx. We had an opportunity in this particular case to stop this from happening before it was ever approved."

- read this AP report for more information