August 1, 2014 — According to Forbes, experts are questioning recent conclusions from the U.S. Food and Drug Administration (FDA) that Benicar (olmesartan) does not increase the risk of cardiovascular events for people with type-2 diabetes on high doses.
The FDA has been looking into the risk since 2010, after two concerning clinical trials were published. The ROADMAP study found a five-fold increased risk of death. Between the two studies, 25 deaths were reported.
In November 2013, researchers published a study of Medicare patients on Benicar and warned:
“High-dose olmesartan was associated with an increased risk of death in diabetic patients treated for 6 months or longer and with a reduced risk of death in nondiabetic patients, when compared with use of other ARBs.”
In June 2014, the FDA closed their safety review and stated that there was “no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients.”
However, the Forbes report indicates that the four-year safety review did not look at studies that were specifically designed to investigate the patient population in question. Therefore, the risk might be better characterized as inconclusive.
A growing number of lawsuits have been filed by people who took Benicar and developed sprue-like enteropathy, a chronic intestinal disease that causes watery diarrhea, severe weight-loss, malnutrition, and fatigue. Some plaintiffs were misdiagnosed with Celiac disease (gluten intolerance) for years, resulting in permanent intestinal damage.
Do I have a Benicar Lawsuit?
The Schmidt Firm, PLLC is currently accepting Benicar induced injury cases in all 50 states. If you or somebody you know has been injured by enteropathy, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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