Diabetes Drug Should Stay Despite Heart Risks, U.S. Advisers Say

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By Steven Reinberg
HealthDay Reporter
Tuesday, July 31, 2007; 12:00 AM

MONDAY, July 30 (HealthDay News) -- The widely prescribed type 2 diabetes drug Avandia should remain on the market, despite studies that suggest it could increase the risk of heart attacks, U.S. health advisers said Monday.

The U.S. Food and Drug Administration advisory panel voted 22-1 to keep the drug on the market, although it recommended Avandia should carry new safety warnings. That vote was preceded by another vote, 20-3, in which panel members agreed that available data does show Avandia increases heart risks.

"The committee felt, almost uniformly, that there is a risk to some patients," said Dr. Clifford Rosen, the acting committee chairman from the Maine Center for Osteoporosis, St. Joseph Hospital, in Bangor.

"There was some increased risk of cardiac events to some patients. The signal for increased risk was there, with some qualifications," he told reporters at a teleconference.

Patients at risk include those with congestive heart failure, heart disease or patients using insulin, Rosen said, adding, "There are clear-cut reasons not to prescribe this drug to certain patients."

But the decision to keep the drug on the market, according to an FDA official, came about because the committee wasn't convinced that the data presented about the risk was conclusive.

"If we have a clear answer, we don't take this to an advisory committee," Dr. Robert Meyer, the director of the FDA's Office of Evaluation II, Center for Drug Evaluation and Research, told reporters.

Dr. Gerald Dal Pan, director of the FDA's Office of Surveillance and Epidemiology, said, "We will go back and formulate what we think should be on the label." Panelists' suggestions included a black box warning or other warning for heart attack, but there was no consensus on how the label should be changed, he said.

The FDA had previously asked the drug's manufacturer, GlaxoSmithKline, to add a black box warning about heart failure.

While the FDA isn't bound to follow the recommendations of its advisory panels, it typically does so.

Following the vote, Glaxo issued a statement from Dr. Ronald Krall, the company's chief medical officer. "We welcome this decision as positive for patients. This was the first opportunity for these scientific experts to review the full data behind Avandia," he said. "The committee recognized the debilitating nature of this disease and the importance of multiple treatment options. Diabetes is a progressive disease that exacts a terrible toll on its victims, and it is important that Avandia remain a treatment option for patients."

Concerns about Avandia (rosiglitazone), part of a class of drugs for diabetes called thiazolidinediones, are based on a meta-analysis of published studies that suggested the drug increases the risk of heart attack by 43 percent.


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