FDA ruling spurs LI doctors to take patients off Avandia

The U.S. Food and Drug Administration's decision to restrict use of the diabetes drug Avandia has persuaded some Long Island doctors to take their patients off the drug while others said they had long ago stopped prescribing it.

Last week, the FDA said doctors can only prescribe Avandia to new diabetic patients if no other drug is available, while European drug regulators suspended its sale altogether. Americans already on Avandia can stay on it, but doctors must fully inform them of the drug's risks.

Doctors cautioned that those taking Avandia should continue to do so until they meet with their health care providers.

The decisions came after three years of controversy following a 2007 study in the New England Journal of Medicine that found a significant increase in heart attacks and death among diabetics who used Avandia, made by the British manufacturer GlaxoSmithKline.

"I think the FDA's decision changes the game," said Dr. Kenneth Hupart, chief of the division of endocrinology, diabetes and metabolism at Nassau University Medical Center in East Meadow. "The quality of the evidence emerging is more persuasive. The FDA acknowledges there still is uncertainty, but I think the decision is a reasonable one, given the fact there is an alternative."

Hupart said that less than 5 percent of his diabetic patients take Avandia. But he said he will now "more forcefully" discuss switching to a similar drug, Actos, made by Takeda Pharmaceutical Co. of Japan, which does not appear to have the same side effects.

Dr. Harmeet Narula, an endocrinologist at Stony Brook University Medical Center, said he came to the same conclusion three years ago. He said about 10 percent of his patients had been on Avandia in 2007. But the study and the fact that he could prescribe Actos persuaded him to take patients off it. Now, he said, none of his patients takes the drug.

"There was another drug with a similar benefit profile without those side effects," he said.

Dr. Leonard Gioia, chief of endocrinology at Good Samaritan Hospital Medical Center in West Islip, said he had stopped prescribing the drug even before the 2007 study because it caused an increase in cholesterol. "I think it could have been taken off the market because we had another drug doing the same thing," he said.