The Food and Drug Administration will hold a meeting in June to reassess the safety of GlaxoSmithKline's former blockbuster diabetes drug Avandia almost three years after they curbed its sales over cardiovascular risks.
Regulators announced the highly unusual move in a government notice published on Friday. The FDA said it will ask a panel of outside experts to review a new analysis of the key study examining Avandia's heart risks.
Avandia was severely restricted in 2010 due to concerns about its impact on the heart.
According to a meeting announcement scheduled to be published in the Federal Register on Monday, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to "discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial."
Presumably, the FDA could loosen restrictions on the drug if new evidence suggests it is not as dangerous as previously thought.
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.
"We haven't asked for any changes in the drug label or in distribution for Avandia," Rhyne said, according to Reuters. Glaxo had not requested the planned June meeting of the FDA's Endocrinologic and Metabolic advisory panel, which will be held jointly with the FDA's Drug Safety and Risk Management Advisory committee.
The FDA will review results of the latest "independent readjudication" of the study that formed the basis for its original approval of rosiglitazone (Avandia).
