FDA puts heavy restrictions on Avandia
The Food and Drug Administration announced Wednesday that effective Nov. 18, 2011, Avandia will be pulled from retail pharmacy shelves due to the diabetes drug's cardiovascular threat to patients.
A 2007 analysis conducted by the Cleveland Clinic cardiologist Steven Nissen, M.D., found that those with type 2 diabetes who took Avandia (rosiglitazone) had a 40% increase in heart attack risk. Several other studies confirmed the risk.
Starting Nov. 18, only certified doctors will be able to prescribe the drug, and only to patients who have been alerted to the risks, who have already taken the drug safely, and who have found that other medications did not control their diabetes. These patients can obtain Avandia through mail-order pharmacies.
Several cardiologists have criticized the FDA for failing to act sooner.
"It's like a decade-long nightmare coming to an end," Nissen told USA Today. "Eleven years after this drug was introduced, it will be so restricted in access that virtually no one will be able to get it."