The Food and Drug Administration will hold a meeting in June to reassess the safety of GlaxoSmithKline's former blockbuster drug Avandia, which was severely restricted in 2010 due to concerns about its impact on the heart.
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.
A spokeswoman for Glaxo said the drug company commissioned researchers at Duke University to reanalyze the study, called RECORD, which followed patients for five years and tracked rates of heart attack, stroke and death. The new analysis "did not show a statistically significant difference," in heart safety between Avandia and older diabetes drugs, according to company spokeswoman Mary Anne Rhyne.