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Benicar (Olmesartan Medoxomil) Overview: High Blood Pressure Treatment
Every year, millions of patients take Benicar (Olmesartan Medoxomil), a popular drug used to treat high blood pressure. The medication works by blocking substances that tighten blood vessels, allowing blood to flow more smoothly and the heart to pump more efficiently. Over the last several years, the drug has been linked to a number of severe gastrointestinal side effects. Symptoms are similar to celiac disease – a condition that damages the lining of the small intestine – and may include chronic diarrhea, vomiting, intestinal inflammation and weight loss. As a result, the FDA has approved label changes of these drugs as well as issued a warning. Warnings about the possible repercussions of Benicar were added to the medication’s label in late 2013. Drug Safety
Benicar Warning: Extreme Gastrointestinal Distress
Benicar is an angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure or hypertension – alone or with other antihypertensive agents – and is one of eight marketed ARB drugs. The U.S. Food and Drug Administration (FDA) warned that the blood pressure drugs marketed as Benicar, Benicar HCT, Azor, Tribenzor and generics can cause severe intestinal problems, also known as sprue-like enteropathy.
Read the FDA Report on Drug Safety
The concerns stem from research conducted by The Mayo Clinic, which examined 22 patients who reported suffering from diarrheal illness for an average of 19 months, and determined that when the patients discontinued using the drug, they gained an average of 27 pounds. Researchers concluded that Olmesartan might be associated with a severe form of sprue-like enteropathy, with symptoms that include severe, chronic diarrhea, nausea and vomiting with substantial weight loss. Chronic diarrhea from use of the medication may also cause villous atrophy, a disorder which causes abnormalities in the intestinal lining.
Over the years, victims have suffered from sprue-like enteropathy after taking Benicar, but were often misdiagnosed with celiac disease.
The enteropathy may develop months – even years – after starting the drug, and sometimes requires hospitalization. If patients taking the medication develop symptoms and no other cause is found, the drug should be discontinued, and therapy with another antihypertensive started. The FDA will continue to evaluate the safety of these medications and will communicate again if additional information becomes available.
Consumers across the country have filed product liability lawsuits against New Jersey-based drug maker Daiichi Sankyo, Inc. after developing severe gastrointestinal issues while taking Benicar. The lawsuits – both individual and class actions – are being reviewed across the country. According to reports, plaintiffs allege the drug manufacturer may have been aware of the association between Benicar and severe stomach issues, yet did not divulge important consumer information – and also failed to conduct adequate studies on Benicar’s long-term effectiveness and risks.
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