FDA has requested a black box warning for the labels of the type 2 diabetes medications Avandia, manufactured by GlaxoSmithKline, and Actos, manufactured by Takeda Pharmaceuticals, because of increased risk for congestive heart failure associated with the medications, agency Commissioner Andrew von Eschenbach announced on Wednesday at a House Oversight and Government Reform Committee hearing, the New York Times reports.
FDA last month issued a public safety warning about Avandia in response to a study published on the New England Journal of Medicine Web site.
FDA and GSK disclosed that, according to a meta-analysis of previous studies conducted by the company in August 2006, participants who took Avandia had a 31% increased risk for cardiovascular events. However, FDA did not take regulatory action on Avandia because of clinical trial data submitted to the agency last August. The data from the trial, which involved 30,000 patients, found that participants who took Avandia had no increased risk for cardiovascular events.
GSK on Tuesday published interim data from a company study on the NEJM Web site. The data indicated no increased risk for cardiovascular events associated with Avandia.
Warning Details
The request from FDA for a black box warning for the labels of Avandia and Actos involved only increased risk for heart failure associated with the medications, not increased risk for heart attacks. Von Eschenbach said that “these drugs were being prescribed to patients with significant heart failure,” despite current warnings on the labels of the treatments.
He said that FDA has not reached a conclusion about whether Avandia and Actos increase risk for heart attacks and continues to analyze related trial data. An FDA advisory committee this summer plans to address the issue.