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Federal drug regulators have completed their review of the potential risk of heart problems that may be associated with side effects of Benicar for diabetics, indicating the findings were inconclusive and that there is no clear evidence of increased cardiovascular risks for diabetic patients.
In a drug safety communication issued June 24, the FDA indicates that recommendations for use of olmesartan-based medications remains the same, however the agency is requiring the makers of Benicar, Benicar HCT, Azor, Tribenzor and generic equivalents to update the warning labels to provide information about some studies that suggest there may be a heart risks for diabetics.
Benicar (olmesartan medoxomil) is a widely-used blood pressure drug that was first approved by the FDA in 2002. It is distributed by Daiichi Sankyo and Forest Laboratories in the U.S.
In June 2010, the FDA announced that the agency was reviewing the side effects of Benicar for diabetics following two clinical trials that suggested the drug may cause an increase in the risk of death due to heart problems. In the two studies, 25 subjects died due to cardiovascular problems while taking Benicar.
The FDA review closely examined data from the studies: the Randomized Olmesartan and Diabetes MicroAlbuminuria Prevention (ROADMAP) trial and the Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial (ORIENT). The FDA then compared those studies to Medicare data and a clinical trial by Daiichi Sankyo.
According to the statement issued this week, the agency has found conflicting data and an overall suggestion that patients experienced a large increase in survival if they took Benicar and did not have diabetes. However, diabetics taking the drug had a greater chance of death.
“The results seem to support the finding in ROADMAP; however, there are concerns regarding the credibility of the results of the Medicare study because of the discrepant findings in diabetics and non-diabetics,” the FDA reports. “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.”
The agency does not explain why it is not plausible for the Benicar side effects to decrease the survival rate of diabetics, even though diabetics are known to be at greater risk for cardiovascular problems.
According to the FDA’s statement, even if the risk is genuine, the agency believes they are outweighed by the health benefits of treating high blood pressure with Benicar.
Benicar Diarrhea Concerns
Last year, the FDA released another drug safety communication involving olmesartan, adding new warnings to the drug label about the risk of sprue-like enteropathy from Benicar, which may cause chronic diarrhea, weight loss and long-term gastrointestinal problems.
Concerns about the link between Benicar and diarrhea problems were first identified in an independent study published in the medical journal Mayo Clinic Proceedings in July 2012.
That study outlined a number of patients using Benicar who experienced celiac disease symptoms. However, unlike individuals typically diagnosed with celiac disease, users of Benicar often did not respond to a gluten free diet and the symptoms of diarrhea often resolved when the medication was no longer used.
Following an FDA review, the agency required manufacturers to warn consumers and the medical community that symptoms like chronic diarrhea may be caused by Benicar, with issues often not appearing until months or even years after the drug was first used.
Although the symptoms typically resolve when the medication is no longer used, individuals may face a risk of suffering long-term complications associated with villous atrophy, which involves the deterioration or decay of the villa in the intestinal tract from chronic diarrhea. This may leave former Benicar users unable to properly absorb nutrients and reduce their digestive capabilities.
Daiichi Sankyo currently faces a growing number of Benicar lawsuits being filed by former users who indicate that they experienced years of problems, often resulting in hospitalization and other complications. According to the complaints, the drug maker knew or should have known about the risk of diarrhea, yet failed to adequately warn consumers or the medical community.