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FDA Weighs in on Benicar Heart Risks

Benicar-labelThe popular blood pressure medication known as Benicar has been the subject of several FDA reviews and clinical studies, as scientists attempt to discern the drug’s inherent risks. Manufactured by Daiichi Sanyo, Benicar (olmesartan medoxomil) was FDA approved more than 12 years ago as one of the newest angiotensin II receptor blockers (ARB) designed to treat patients with hypertension.

Back in 2010, health regulators at the FDA announced they were analyzing potential Benicar heart risks in individuals with Type 2 diabetes, as earlier studies had revealed an unexpected rate of cardiovascular deaths in patients taking olmesartan versus those taking a placebo.  The two clinical trials they reviewed included the ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) and ORIENT – both long-term studies that found a greater rate of sudden death, heart attacks and stroke in Benicar users compared to a control group.

2014: FDA finds no clear evidence of Benicar heart risks

Fast forward four years later to June 24, 2014, when the FDA issues a new drug safety communication on olmesartan risks. According to the notice, the agency found “no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients.  As a result, our recommendations for use of olmesartan (Benicar, Benicar HCT, Azor, Tribenzor, and generics) will remain the same, but we will require information about some of the studies to be included in the drug labels.”

However, some hypertension experts find the FDA’s findings somewhat puzzling, as only one study included in the agency’s review focused specifically on Type 2 diabetic patients taking high doses of Benicar. After reviewing the results of this particular Medicare study, the agency concluded “The observation of a large decrease in survival in patients with diabetes taking high doses of olmesartan, coupled with a large increase in survival in non-diabetic patients taking olmesartan—all relative to other drugs of the same class—is not a plausible finding.”

In a recent healthcare piece, hypertension experts Sripal Bangalore and Franz Messerli offer the following comments on Benicar side effects: “The FDA states that this safety review supposedly was prompted by the results of the ROADMAP trial. However, none of these analyses addresses the question whether the increased mortality in ROADMAP was possibly a reflection of the J-curve relationship with BP… Given that no pathophysiologic explanation of these findings has been put forward, the FDA obviously decided in dubio pro reo [when in doubt, for the accused], i.e. olmesartan remains safe. This seems surprising since usually the agency reacts promptly whenever there is even a remote question of harm. In view of the Medicare data the FDA’s verdict may turn out to be wishful thinking more than anything.”

Litigation against Daiichi Sanyo mounts

While the medical community continues to research Benicar heart risks in diabetic patients, one hazard remains clear: severe gastrointestinal problems associated with the drug. Known as sprue-like enteropathy, this ailment is characterized by persistent diarrhea, major weight loss, nausea and malabsorption of nutrients. Some Benicar users who were incorrectly diagnosed went on the suffer malnutrition and damage to the intestinal lining. Fortunately, discontinuation of Benicar results in improvement of sprue-like enteropathy symptoms.

Daiichi Sanyo now faces a handful of Benicar lawsuits related to this gastrointestinal side effect, with plaintiffs suing on counts of failure to warn, negligent misrepresentation and fraud.

  1., FDA Once Again Reaches Conclusions At Odds With Its Own Staff

  2., FDA reviewing safety of olmesartan (Benicar)