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Benicar Risks Still Worry Some FDA Scientists

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As a growing number of Benicar lawsuits are being filed over the blood pressure drug maker’s failure to warn about the risk of chronic diarrhea and other gastrointestinal problems, some experts both in and out of government are voicing concerns about a recent FDA decision to declare that there is no evidence side effects of Benicar include increased cardiovascular risks. 

According to a recent report by Forbes, some FDA scientists question the agency’s decision last month to conclude that there is no conclusive evidence linking Benicar and heart risks.

The agency’s decision came after a study found increased risks of cardiovascular problems at high doses of Benicar among diabetics. The study, which led to a four-year review, involved four of the agency’s own scientists.

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 potential heart risks with Benicar for diabetics, following clinical trials that suggested the drug may cause an increase in the chances for cardiovascular death. In the two studies, 25 subjects died due to heart problems while taking Benicar.

Despite the findings of its own employees, who worked on the initial study, last month the FDA declared that it had found no clear evidence of increased that Benicar carried cardiovascular risks. The FDA determined that other studies contradicted the report that launched the review, and indicated that it was difficult to explain why diabetics only would be affected.

Scientists who worked on the study and for the FDA characterized the agency’s action last month as reassuring, when in fact the best it could determine after four years was that the risk was inconclusive.

The Forbes report notes that the FDA does not address the fact that the other studies were not geared to look at the specific patient population like the original study, and the agency also appeared to ignore the fact that the original study provided a plausible explanation for the difference in Benicar side effects for diabetics and non-diabetics.

Benicar Diarrhea Risks

The concerns come as amid an increasing number of product liability lawsuits that allege drug maker Daiichi Sankyo withheld important safety warnings about link between side effects of Benicar and chronic diarrhea caused by a condition known as sprue-like enteropathy.

Last year, the FDA required new warnings to the drug label about the risk of sprue-like enteropathy from Benicar, which was 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 from Benicar 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.

According to allegations raised in a growing number of lawsuits filed nationwide, Daiichi Sankyo knew or should have known about the diarrea risks with Benicar, yet failed to adequately warn consumers or the medical community. These symptoms may develop months or even years after first use of the medication, and plaintiffs allege that the failure to warn about these risks resulted in repeated hospitalization and permanent gastrointestinal damage because the connection between the diarrhea and Benicar use was not recognized by the medical community.

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