August 1, 2014 — Forbes is reporting that some experts are questioning a conclusion from the U.S. Food and Drug Administration (FDA) that Benicar (olmesartan) does not have cardiovascular risks for diabetic patients on high doses.
The FDA began investigating the risk June 2010. The review was prompted by results of the ORIENT and ROADMAP clinical trials. ROADMAP linked Benicar to a 5-fold increased risk of cardiovascular death. Between the two studies, there were 25 deaths in diabetic patients on high doses of Benicar.
After a four-year safety review, the FDA concluded that there was “no clear evidence” of an increased risk. The FDA was also unsure why only diabetics would have a higher risk of death, whereas non-diabetics had a reduced risk.
The conclusions of the FDA are contradicted by a massive study of Medicare patients on Benicar that was published in November 2013. Researchers 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.”
According to the Forbes report, the problem is that several additional studies reviewed by the FDA were not specifically designed to look at diabetic patients on high doses of Benicar. Therefore, there is little evidence of safety and the risk might be better described as inconclusive.
Daiichi Sankyo, the manufacturer of Benicar, is facing an increasing number of product liability lawsuits from people who were injured by sprue-like enteropathy, a gastrointestinal illness that causes chronic watery diarrhea, weight-loss, and fatigue. Because these symptoms resemble Celiac disease, many people were misdiagnosed for years.
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