Once again the controversial diabetes drug rosiglitazone (Avandia) will be the subject of a 2 day Food and Drug Administration (FDA) hearing. The U.S. Food and Drug Administration is taking the unusual step of re-evaluating the evidence of safety risks from the once popular diabetes drug Avandia, whose sales were sharply restricted by the federal agency three years ago because of cardiovascular risks. The re-evaluation is to better assess the drug’s safety.
The FDA first approved the drug in 1999 and it became the top-selling diabetes pill in the world by 2006. Sales began plummeting in 2007 after researchers began questioning the drug’s safety.
The FDA in September 2010 placed severe restrictions on use of the pill, due to heart attacks and deaths linked to the product, saying it should be available only to patients who cannot control their diabetes with any other drug.
In July 2010, FDA scientists said the study, known as the Record trial, was flawed and that it may have undercounted the number of heart attacks among people taking the drug. The drug is still sold in the U.S. market, but in 2010 the FDA imposed sharp restrictions that require GlaxoSmithKline, the manufacturer, to provide to patients the risk information-and documentation from health-care providers that the risk information has been shared with each patient.
Presumably, the FDA could loosen restrictions on the drug if new evidence suggests it is not as dangerous as previously thought.