Doctors Not Ready to Abandon Diabetes Drug

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An editorial published in the May 26 issue of The Lancet advocated "a calmer and more considered approach to the safety of rosiglitazone," which is made by the pharmaceutical firm GlaxoSmithKline.

The U.S. Food and Drug Administration responded to the study findings by issuing a safety alert Monday for the drug, but stopped short of a stronger warning label, saying more analysis was needed.

"At this point, we have not reached a definitive conclusion on the data," Dr. Robert J. Meyer, director of FDA's Office of Drug Evaluation II, said at the time. "We don't feel there is consistent enough data to make a decision from a regulatory standpoint. We are not ready to make an action."

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The FDA also pointed out that, while some data indicated a risk for heart attack with Avandia, other published and unpublished studies showed just the opposite.

On Thursday, Sen. Charles Grassley said the FDA's own preliminary research on Avandia confirmed the heart risks reported in the New England Journal of Medicine study. The FDA findings suggested that as many as 60,000 to 100,000 heart attacks might be linked to use of the drug, which came on the market eight years ago, the Iowa Republican said, according to the Associated Press.

In a statement read on the Senate floor that was placed in the official record, Grassley also said that safety watchdogs at the FDA recommended "several months ago" that a "black-box warning" -- the strongest possible warning -- be placed on the drug, the news service said.

FDA spokeswoman Julie Zawisza confirmed Thursday the existence of the internal analysis that Grassley's statement revealed. But she added that "we have conflicting data" from individual studies, and therefore "are continuing to review the results of [GlaxoSmithKline's] ongoing trial to determine the actual risk," the AP reported.

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