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Questions about personal health should always be referred to a physician or other health care professional. Food and Drug Administration announced Monday that it is lifting the tough safety restrictions it imposed on the diabetes drug Avandia two years ago because of reported links to heart problems. The agency's decision was expected, and follows up on a June vote by an expert advisory panel to rescind the restrictions, based on new data that suggested the medication may not be as harmful as once thought.
Avandia had been taken off drug store shelves in , and its use restricted to patients who first signed a waiver saying they understood the possible risks. Only specially registered pharmacies could dispense Avandia. But an independent review by Duke University researchers, based on Avandia's original clinical trial, concluded that patients had no elevated risk of heart attack or death compared with those taking standard diabetes drugs. Thus, we are requiring the removal of certain prescribing restrictions.
Steven Nissen, head of cardiology at Cleveland Clinic, first sounded the alarm about Avandia in with an analysis of 42 studies that showed that the medication caused a 43 percent increased risk of heart attack. Following his study, an FDA analysis of more than 50 studies concluded that Avandia was linked to an increased risk of heart problems, and the agency decided to pull the drug from pharmacy shelves.
This was the review that led to Monday's decision. Nissen condemned the FDA's latest action. Only specially registered pharmacies could dispense Avandia. But an independent review by Duke University researchers, based on Avandia's original clinical trial , concluded that patients had no elevated risk of heart attack or death compared with those taking standard diabetes drugs.
Thus, we are requiring the removal of certain prescribing restrictions. Steven Nissen, head of cardiology at Cleveland Clinic, first sounded the alarm about Avandia in with an analysis of 42 studies that showed that the medication caused a 43 percent increased risk of heart attack.
Following his study, an FDA analysis of more than 50 studies concluded that Avandia was linked to an increased risk of heart problems, and the agency decided to pull the drug from pharmacy shelves. This was the review that led to Monday's decision.
Nissen condemned the FDA's latest action. It does not make any good regulatory sense, and in fact it's rather bizarre. Yehuda Handelsman, an endocrinologist in Tarzana, Calif. Many of us never thought the information brought against the drug was very scientifically solid or correct," Handelsman said of the announcement.
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