NEW RESTRICTIONS FOR AVANDIA
On Thursday, September 23, 2010 the FDA announced that sales for the once popular diabetes drug, Avandia, will now only be prescribed to patients after they and their doctors attest that the patients tried every other diabetes medication and the patients are aware of the substantial heart risks of Avandia. It is currently estimated that 600,000 people are currently on Avandia, so this new restriction will have an immediate impact.
In 2007, Dr. Steven Nissen, a Cleveland Clinic cardiologist, reported a study finding Avandia increased the risk of heart attacks, despite an advisory committee agreement, it still voted to keep it on the market. After Thursday’s new, Dr. Steven Nissen said that the FDA decision brought an end to “one of the worst drug safety tragedies in our lifetime,” adding that it was “essential to fully investigate what went wrong with the regulatory process to prevent this type of tragedy from endangering patients in the future.”
In a recent study, it was estimated over 47,000 people suffered heart attacks, stroke or death caused by Avandia in a ten year period.
Also reported on Thursday, the sales for Avandia have been completely suspended in Europe.