FDA Investigating Heart Deaths Linked to Blood Pressure Medication

The U.S. Food and Drug Administration is investigating whether a blood pressure medication increases the risk of cardiovascular death.

The FDA said in a safety notice that it is reviewing data from two long-term clinical trials in which patients with Type II diabetes were given either Daiichi Sankyo’s Benicar or a placebo. In an “unexpected finding,” Benicar-treated patients suffered a greater number of deaths, the FDA said in its statement on Friday.

In one study of more than 4,400 patients, there were 15 heart-related deaths compared with three in the placebo group. In the other study of 557 patients, there were 10 cardiac deaths versus three on the placebo.

Daiichi Sankyo’s chief scientific officer told Reuters that Benicar and other medicines in the same drug classification have “been around for a long time,” and that the company was ”very confident, as the FDA has been, in both the efficacy and the safety” of Benicar.

The FDA is encouraging healthcare professionals and patients to report adverse Benicar-related events or side effects.

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