Twelve members voted to withdraw Avandia from the market, while 10 voted that it should continue to be sold but with serious revisions to its label as well as possible restrictions on its sale. Seven voted to simply add further warnings to the drug’s label. Three voted to allow further sales without change.
The FDA will make a final decision on the drug at a later date.
Nearly 700,000 Ohioans have been diagnosed with diabetes, or nearly one in 10 adults (9.5 percent), according to a 2008 survey by the Ohio Department of Health. Of those diagnosed with diabetes, nearly 60 percent take a medication such as Avandia to help control their blood sugar.
The panel’s mixed signal is not what some doctors had been hoping for, including Dr. Miguell Parilo, a diabetes specialist with the Bull Family Diabetes Center of Premier Health Partners. “Ever since this controversy began, I’ve had concern for my patients,” he said.
Parilo says he no longer prescribes Avandia for his own patients, but a small percentage of those referred to him from other doctors are taking the drug to help control their blood sugar. In those cases, Parilo said he discusses with the patient whether a switch to a similar drug, Actos, might be safer.
After its introduction by British pharmaceutical giant GlaxoSmithKline 10 years ago, Avandia became the leading prescription for treating diabetes, reaching $3 billion in sales worldwide. Sales began to drop three years ago when the first studies appeared apparently linking Avandia to increased heart attacks and strokes.
Glaxo’s revenues from Avandia are down to about $1 billion, with fewer and fewer physicians prescribing the medication, including doctors in the Dayton area, Parilo said.
Dr. Robert Cohen, a professor in the Division of Endocrinology, Diabetes and Metabolism at the University of Cincinnati Medical Center, said the FDA’s panel’s decision is exactly what he had expected. “My impression has been the FDA’s own staff has been pretty divided by this,” he said. “Probably some restriction is reasonable, but I’m not certain taking it off the market is necessarily the right answer.”
Cohen said he has not been convinced by FDA data that Avandia presents any more risk than Actos, a similar diabetes drug manufactured by Takeda of Japan. What is clear, he said, is that both drugs increase the risk for heart failure — that is, eventual weakening of the heart muscles and the build-up of fluids in the body.
Any risk associated with the drugs also must be weighed against the long-term effects of diabetes, which was the sixth leading cause of death for Ohioans in 2005.
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