3 years ago
Washington, D.C. - The government is putting a prominent, but confusing, warning on the popular diabetes drug Avandia.
It tells patients that the drug may, or may not, increase the risk of heart attacks.
The Food and Drug Administration has concluded that studies are too contradictory to tell if Avandia is actually riskier than other treatments for Type 2 diabetes.
The move follows much harsher action from Canadian officials who have restricted the drug's use to hard-to-treat diabetics.
Manufacturer GlaxoSmithKline has agreed to the FDA's demand for a major study directly comparing Avandia and its competitors' effects on the heart. The study will begin by next November and won't end until 2014.
The FDA plans to order interim checks to see how patients are faring and if it's possible to settle the issue any sooner.
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