Product News and Recalls

FDA investigates blood pressure medication

The U.S. Food and Drug Administration launched an investigation into whether the blood pressure medication Benicar increases the risk of heart-related deaths, Reuters reports.

According to the story, the agency is evaluating clinical data from two drug trials. In both of them, diabetes patients who took the drug had a higher rate of death from heart-related causes than patients taking a placebo.

Benicar, the brand name for the drug known chemically as olmesartan, was given to some patients with type 2 diabetes in the course of the long-term trials to determine whether it would slow the progression of kidney disease or diabetes. Other patients took a placebo.

In the larger of the two trials, the story says, Benicar did appear to slow the onset of kidney disease. But both trials uncovered an unexpected finding — a greater number of deaths from heart attack, stroke or sudden death in the patients who received Benicar compared with those who took a placebo.

In the larger of the two studies, which included more than 4,400 patients who took either Benicar or placebo, there were 15 heart-related deaths in the drug group versus three on placebo, the story says.

Benicar, manufactured by Daiichi Sankyo, belongs to a class known as angiotensin receptor blockers, or ARBs, that are also used to prevent kidney failure. Other ARBs include Novartis AG’s Diovan and Merck & Co’s Cozaar.

A recent Mayo Clinic report has also linked Benicar to stomach problems including chronic diarrhea, vomiting, intestinal inflammation and weight loss.

You should consult with a doctor if you have any ongoing symptoms or health concerns, and before making any changes in medication. You should also consult with a lawyer if you have injuries connected with Benicar.

See the story here:

http://www.reuters.com/article/2010/06/11/fda-benicar-idUSN1113920620100611