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The US Food and Drug Administration (FDA) has begun its probe into a popular diabetes treatment amid concerns that it may be linked to heart attacks.
Avandia, which has been on the market for more than a decade, has been used by millions of patients and generated billions of dollars in sales for manufacturer GlaxoSmithKilne.
The FDA is to seek advice from a panel of external advisers after its own scientists were unable to resolve the seemingly contradictory data on the drug’s role in cardiac arrests.
The probe was prompted by new studies of Medicare records, which appeared to suggest a stronger connection than previously believed, and pressure from public safety organisations.
FDA Commissioner Margaret Hamburg called on the panel to “follow the science wherever it leads and the rest will fall into place”.
Avandia was Glaxo’s third best-selling drug in 2006 with US revenue of $2.2 billion, however sales have plummeted 75% due to growing safety concerns, slipping to $520 million last year.
The drug, which enables sufferers to make more efficient use of insulin, is normally prescribed for Type 2 diabetes.
Copyright Press Association 2010
