The FDA cited data from two clinical trials that showed patients with type 2 diabetes who took Benicar (olmesartan) had a higher rate of death from cardiovascular causes than patients taking a placebo.
"FDA's review is ongoing and the agency has not concluded that Benicar increases the risk of death," the FDA said in a statement, adding it "currently believes the benefits of Benicar in patients with high blood pressure continue to outweigh its potential risks."
Officials said they will review primary data from the two studies and are considering additional ways to assess the cardiovascular effects of Benicar.
In both trials, patients with type 2 diabetes were given either Benicar or a placebo to determine if treatment with Benicar would slow the progression of kidney disease. The federal agency said an unexpected finding observed in both trials was a greater number of deaths from a cardiovascular cause (heart attack, sudden death or stroke) in the Benicar-treated patients compared to placebo patients.
Benicar is marketed in the United States by Daiichi Sankyo Inc.