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Page: << Prev | 1 | 2 | 3 "This hazard of heart failure is pretty well known for these drugs," said Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic. He noted that, in May, the FDA said it was going to mandate a "black box" warning about heart failure risk on the labels of these drugs.
That same month, Nissen published a paper in the New England Journal of Medicine that found that Avandia increased the risk of heart attack.
Since then, the controversy has continued, with both sides weighing in.
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On Thursday, Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline, which makes Avandia, responded to the new government review by saying the company continued to believe Avandia was safe, the Times reported.
"Across the extensive data we have, the science shows no increase in cardiovascular death, and does not support a difference in heart attack rates between Avandia and the other most commonly prescribed oral antidiabetics," Rhyne told the Times.
On Friday, the company's director of clinical development, Dr. Andy Zambanini, told HealthDay that Glaxo was "still in negotiation with the FDA about a new warning label on heart failure, and we expect to release that information soon."
Nissen believes that patients who are considering taking Avandia should discuss the decision with their doctor. "It is important that the totality of information be out there," he said. "But no patient should stop taking a medication [only] because they read a news report."
Another expert contends that the two drugs are safe if prescribed correctly.
"The risk for heart failure with these drugs may be one in 50, but if you can correctly identify who that person [at risk] is, you can safely treat the other 49 and not hurt anybody," said Dr. Larry Deeb, president for medicine and science at the American Diabetes Association.
Deeb believes the same holds true for the risk of heart attack.
The boost in risk of heart failure and heart attack does not warrant taking these drugs off the market, he added.
"They fit into the armamentarium of diabetes drugs if used properly," Deeb said.
More information
Learn more about diabetes drugs from the U.S. Food and Drug Administration.
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