US FDA lifts restrictions on Glaxo diabetes drug Avandia

Mon Nov 25, 2013 2:58pm EST

Nov 25 (Reuters) - U.S. health regulators on Monday said they would lift restrictions on the use of GlaxoSmithKline Plc's once widely used diabetes drug Avandia after determining that it did not increase the risk of heart attacks.

The U.S. Food and Drug Administration, following its review of a large clinical trial called Record, said it found that the trial showed no elevated risk of heart attack or death in patients being treated with Avandia when compared with standard-of-care diabetes drugs.

These data do not confirm the signal of increased risk of heart attacks that was found in an analysis of previous clinical trials first reported in 2007, the FDA said in a statement.

Avandia, which had been one of Glaxo's top-selling medicines with sales of $3.2 billion in 2006, was pulled from the market in Europe and had severe restrictions placed on its use in the United States in 2010 due in part to ambiguity about a possible increased risk of heart attack and stroke seen in the Record study, as well as a review of other studies.

The drug was placed in a highly unfavorable light in 2007 after Dr. Steven Nissen, head of cardiology at the Cleveland Clinic, reported results of a so-called meta-analysis in which data from 42 studies was pooled and analyzed, showing a 43 percent increased risk of heart attack from Avandia.

GlaxoSmithKline could not immediately be reached to comment on the FDA decision. But the British drugmaker had previously said it was not likely to put its marketing muscle behind Avandia again, even if the FDA were to lift the usage restrictions.

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