The FDA Chooses Avandia Over Patients
Updated August 2007: The FDA has known of the risk of heart failure associated with Avandia, a type 2 diabetes medicine, for years. Even before the drug was approved, researchers mentioned that there was a risk of cardiovascular illness.
But the FDA has chosen not to act on any of the warnings from researchers and studies linking Avandia to a high risk of heart attack. Public Citizen obtained internal FDA information that proves that the FDA was aware that there was some heart attack risk associated with the drug. The public interest group received a 2002 internal memo that reported that there were 25 cases in which the use of Avandia was associated with hospitalization for heart failure. There were also 22 cases of the same problem with the drug Actos, a similar drug for type 2 diabetes.
As of last fall numbers of hospital visits due to heart failure from Avandia has risen to 415 cases, and 388 for Actos. When the patients stopped taking the drug, the heart failure rates were lower. The memo recommended adding this information to the drug’s label.
The FDA did add some warning labels to Avandia, but it was not until a study by Steven Nissen was published in the New England Journal of Medicine that showed how high the risk for heart attack was for Avandia users, that added a black box warning concerning heart failure on the drugs labeling.
This study which finally informed the public of the heart attack risk linked to Avandia forced the FDA to call for a meeting about the drug. The meeting, which was held on July 30, ended with the FDA in favor of keeping Avandia on the market. The FDA advisory committee voted that the diabetes drug does raise the risk of heart attack, but the panel also voted 22 to 1 to keep GlaxoSmithKline’s drug available to the public. This decision shows that the FDA may favor the drug companies over the interests of patients.