Avandia Warnings Ignored by FDA
Avandia, a drug for patients with diabetes, was approved on May 25, 1999. The drug was approved because it was shown to be effective in reducing blood sugar levels. Even before the drug was approved, however, there were warnings that revealed that the drug may increase the risk of heart attacks.
The primary FDA reviewer of the clinical trials recommended that the drug be approved, but under the condition that a post-marketing study be done to address the problems found with the drug. He stated that “Heart disease due to atherosclerosis is a major cause of morbidity and morality in patients with type 2 diabetes, and it cannot be assumed that treatment with Avandia will decrease the risk”. The study was never performed.
On May 21, 2007, the New England Journal of Medicine published a meta-analysis that showed a 43% excess incidence of heart attack in Avandia patients and a 64% increase in the likelihood of death related to cardiovascular diseases.
In response to the New England Journal study and the review hearing the FDA issued a public safety warning on May 21st. Shortly after, the FDA issued a request to have a black box warning added to the labels of the type 2 diabetes medications Avandia and Actos. The FDA states that they have not reached a conclusion about whether Avandia increases the risk for heart attacks and will continue to analyze the data.