Diabetes Drug Avandia Banned in Europe for Causing Cardiovascular Death, but FDA Clears it in U.S.

Diabetes drug Avandia was linked to significantly increased risks of heart attack and cardiovascular death, prompting the FDA to restrict access to the drug in 2010. Europe banned Avandia, taking it completely off the market. The FDA has now announced it is lifting those restrictions to allow widespread access to the drug once again. The decision was based on a heavily criticized study conducted by the drug’s maker, GlaxoSmithKline (which pleaded guilty to fraud in 2012 for failing to report safety problems with Avandia).

FDA About to Greenlight a Drug Banned in Other Countries

Remember the controversial diabetes drug Avandia? In 2010, two FDA drug safety reviewers warned the agency that Avandia posed serious risks of heart attack and heart failure when compared with other diabetes drugs. Since then, the drug has been removed from the market in most countries and has been under severe restrictions in the US. Recently, in a combined meeting of separate FDA advisory committees, 20 of 26 panelists voted to recommend removing or modifying Avandia’s highly restrictive label and distribution system.