The Food and Drug Administration (FDA) has decided to reopen the case of the diabetes drug Avandia which was banned in the United States after researchers found that thousands of people had heart problems after taking it.
The FDA will ask a panel of experts this week whether the agency must reconsider the restrictions on the drug, the New York Times notes. Experts could recommend lifting restrictions on the drug, among other options.
The positive safety review from Duke University researchers is the latest development in a years-long debate over Avandia, which has divided medical experts, cost GlaxoSmithKlinebillions of dollars and possibly resulted in an unknown number of patient heart attacks.
The drug was first approved in 1999, and quickly became the top-selling diabetes pill in the world by 2006 with sales of $3.4 billion. However, prescriptions plunged the following year after an analysis of dozens of studies suggested Avandia could increase the risk of heart attack.
European regulators, on the other hand, suspended the drug's marketing authorization in Europe at that time.
"It's the wrong reason to take a regulatory action," said Dr. Steven Nissen of the Cleveland Clinic, who authored the 2007 analysis that first raised public safety concerns about Avandia, the Associated Press notes.
"You want to take a regulatory action because it's going to benefit patients. I don't see how patients could possibly benefit from lifting these regulatory restrictions."
