07/30/2007-
One million Americans with Type-2 Diabetes take Avandia to control blood sugar; however studies show it can increase the risk of heart attacks by 43 percent.
FDA Scientist David Graham says the drug should be pulled because the risks outweigh the benefits. He also said, "A wrong decision will cost thousands of lives."
The FDA Advisory Committee met Monday to consider recommending stronger warning labels for Avandia, restricting its use, or pulling it.
Among those testifying, Sidney Wolf from the consumer group Public Citizen. He said, "There is no evidence of any unique, beneficial clinical outcome for Avandia. And (there's) growing evidence of multiple organ system damage."
Avandia helps control blood sugar by increasing the body's sensitivity to insulin. But it's also been shown to raise bad cholesterol and cause weight gain.
"This kind of data again is a red flag for the diabetes community," said Dr. Mark Schutta, the Medical Director of the Diabetes Center at the University of Pennsylvania.
Dr. Schutta also said, "The question becomes is it the weight that's increasing their cardiovascular risk? Is it the fact that their bad cholesterol, the LDL, cholesterol is going up that's doing it? Or is it some other factor that we really don't know about?"
The maker of Avandia, GlaxoSmithKline, based here in Philadelphia says the drug is safe. A recommendation vote is expected Monday evening. The FDA usually follows the recommendation.
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