NEW YORK, June 11 (Reuters) - The U.S. Food and Drug Administration is looking into whether Daiichi Sankyo's blood pressure medicine Benicar increases the risk of death, although the agency said it still believes the benefits of the drug outweigh its potential risks.
The FDA said it was evaluating data from a pair of clinical trials in which diabetes patients taking the drug, known chemically as olmesartan, had a higher rate of death from heart-related causes compared to patients taking a placebo.
In a safety notice posted on Friday, the agency cautioned that it has not concluded that Benicar increases the risk of death.
In addition to reviewing data from the two studies, the FDA said it is considering additional ways to assess the heart disease effects of Benicar.
In both long-term trials, patients with type 2 diabetes were given either Benicar or placebo to determine if Benicar would slow the progression of kidney disease.
An unexpected finding in both trials was a greater number of deaths from heart attack, stroke or sudden death in the Benicar-treated patients compared to placebo, the FDA said.
There are several classes of drugs that work different ways to treat high blood pressure. Benicar belongs a class known as angiotensin receptor blockers, or ARBs, that are also used to prevent kidney failure.
Other ARBs include Merck & Co's Cozaar and Novartis' Diovan.
The FDA is encouraging healthcare professionals and patients to report side effects related to the use of Benicar.
Daiichi Sankyo could not immediately be reached to comment on the FDA report.
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