Glaxo’s Avandia Cleared From Sales Restrictions by FDA
This article is for subscribers only.
GlaxoSmithKline Plc’s much-maligned diabetes drug Avandia will be released from restrictions preventing sales to certain patients after U.S. regulators determined new data show the medicine doesn’t raise heart risks.
The Food and Drug Administration reviewed independent researchers’ reanalysis of a Glaxo study, called Record, that confirmed Avandia doesn’t raise the risk of death, heart attack or stroke. Avandia’s reign atop the diabetes market as a $3 billion-a-year medicine began to end after a 2007 New England Journal of Medicine article found a 43 percent increased risk of heart attack in patients taking the drug in a combination of results from smaller studies.