U.S. and European drug agencies came to a similar decision to severely restrict use of the antidiabetes medication rosiglitazone, or Avandia. But while the European Medicines Agency is suspending sales of the drug in E.U. countries, the U.S. Food and Drug Administration followed the advice of its advisory committee and decided to leave the controversial drug on the market, with restricted access.
Avandia helps patients with Type 2 diabetes control blood sugar, but has been linked to an increased risk of heart events. The FDA will now require stricter requirements for when the drug can be prescribed to patients. Only those who have exhausted other antidiabetes medications — including a similar drug in the same class as Avandia that is not associated with the same degree of heart problems — may now use the medication. (More on Time.com: Clinical Trial Dilemma: Save Lives Now — or Later?)
The agency is also requiring that any physician, patient or pharmacist dispensing Avandia be enrolled in a special certification program that ensures they are fully aware of the heightened heart risks associated with the drug.
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