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Benicar Sprue-Like Enteropathy Continuing to Drive Litigation

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Little Rock, ARWhile all medications have side effects, it’s evident that some side effects are more serious than others. In the case of Benicar side effects, a malady known as sprue-like enteropathy can trigger chronic diarrhea and other gastrointestinal ailments that have the potential to foster weight loss, dehydration and serious health issues going forward.

Olmesartan (Benicar) is prescribed to treat high blood pressure (hypertension), a condition that affects a large segment of the American population. And while Benicar is classed as an angiotensin II receptor blocker (ARB), the US Food and Drug Administration (FDA) has determined that other drugs in the ARB class do not carry the same kind of link to sprue-like enteropathy that Benicar appears to carry.

Research appears to bear that out. A study under the auspices of the Mayo Clinic in 2012 suggested a link to sprue-like enteropathy, prompting the FDA the following year to issue a warning about Benicar Illness and Weight Loss.

The potential link between Benicar and sprue-like enteropathy, however, is not without its detractors, who cite results of the ROADMAP Phase-3 trial that saw a rate of diarrhea pretty much equal in patients treated with Benicar and controls treated with placebo only.

Last May, French researchers attempted to address that doubt by launching a study with a large, nationwide cohort totaling a massive 4,546,680 patients. The research, entitled “Severe Malabsorption Associated with Olmesartan: a French Nationwide Cohort Study,” was published last May in Gastroenterology and concluded that Benicar was, indeed, associated with severe malabsorption. Study authors noted that the increased risk for Benicar side effects was seen to emerge after the first year of treatment, and reached a 9.53 times greater risk following two years or longer on Benicar.

Benicar lawsuits have followed. Some Benicar patients have been hospitalized. Others have died from complications stemming from Benicar defective products, or so it has been alleged.

On a related note, the manufacturer of Benicar, Daiicho Sankyo, was required to pay $39 million in civil damages and penalties in order to settle alleged violations against the False Claims Act through the offering of meals and speaker’s fees to physicians as incentives for prescribing Benicar and other drugs manufactured by the company.

The Arkansas Democrat-Gazette (3/17/14) reports that of the $39 million available in the multi-state settlement, Arkansas will receive $15,459.81 in compensation. The Attorney General for the State of Arkansas, Leslie Rutledge, indicated the money will be put toward the state’s Medicaid trust fund.

In the meantime, various Benicar lawsuits allege that plaintiffs were not aware that their blood pressure medication could saddle them with even more serious health issues like sprue-like enteropathy.

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