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Benicar Linked to Gastrointestinal Problems

  • Author Drug Dangers Team
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The number of Benicar lawsuits continues to grow, as nearly 100 additional patients came forward in August to file a suit against Daiichi Sankyo, Inc., Daiichi Sankyo Co. Ltd., and Forest Laboratories, Inc. the companies that make or promote Benicar.

Olmesartan medoxomil, sold under several brand names including Benicar, is an angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure. It can be used alone or with other antihypertensive agents.

Benicar is a prescription medication intended to treat patients with high blood pressure. The drug was approved in April 2002 by the FDA. In the more than 10 years since it has been in use, patients have reported the development of a condition known as sprue-like enteropathy, which causes severe gastrointestinal symptoms, including chronic vomiting, diarrhea, and nausea, as well as weight loss and malnutrition.

FDA Warning

The reports filed against Benicar became such a concern that in July 2013 the FDA issued a Safety Announcement based on data from the Mayo Clinic showing the drug’s likely link to sprue-like enteropathy. The study showed 22 patients taking olmesartan developed diarrhea, weight loss, and villous atrophy while on the drug. They also showed clinical improvement after stopping use of the drug.

Following review of the data, the FDA ordered changes to Benicar’s label, so users would be aware of the dangers associated with the drug. In its statement regarding Benicar and sprue-like enteropathy, the FDA stated it will continue to evaluate the safety of olmesartan-containing products, including Benicar, and will provide further information when it becomes available.

As lawsuits mounted, the cases were consolidated into multidistrict litigation in the US District Court in New Jersey. Plaintiffs allege that Benicar is unreasonably dangerous and was marketing in a misleading manner. They also claim information about the side effects of the medication were delayed in their submission to the FDA.

What is Sprue-like Enteropathy?

Sprue-like enteropathy is a gastrointestinal disease that triggers chronic diarrhea, and as a result, weight loss and malnutrition. Sufferers also experience ongoing nausea, bloating, stomach pain, constipation, pale, foul-smelling stool, and eventually have problems with their immune system. For many, the symptoms require emergency hospitalization.

For some Benicar users, the symptoms might not appear for months or years after they begin using the medication, which makes an accurate diagnosis difficult. Patients are encouraged to discuss their Benicar use with their doctor if any symptoms of sprue-like enteropathy develop and ask if use can be discontinued if no other cause can be found for the symptoms the patient is experiencing. It is important to never stop using a medication without your doctor’s approval.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 

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