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Study Reveals Benicar® (olmesartan) Linked to Severe Gastrointestinal Problems, Researchers Warn at Digestive Disease Week Conference

Pill BottleA French study involving Benicar® (olmesartan) was recently discussed during the annual Digestive Disease Week (DDW) conference held in Chicago in June. The findings of the French cohort study were published in Family Practice News on June 20, 2014, where one of the researchers warned that the antihypertensive drug, Benicar® (olmesartan), is linked to an increased risk of severe sprue-like enteropathy.

The study, conducted by researchers from the University of Paris and the French National Health, revealed an association between Benicar® (olmesartan) and severe intestinal malabsorption, leading to dehydration, malnutrition, substantial weight loss, and severe chronic diarrhea. The French study found no such link in patients taking other antihypertensive drugs, including ACE inhibitors or angiotensin receptor blockers (ARBs). The study included an examination of data on 4.5 million patients covered by the French national health insurance plan who started taking Benicar® (olmesartan) or other antihypertensive drugs during 2007 to 2012. During the first year of Benicar® (olmesartan) use, the number of individuals hospitalized for intestinal malabsorption was 2.6 cases per 100,000 person-years. Such cases rose to 6.7 per 100,000 person-years during the second year, which increased to 8.9 cases per 100,000 person-years by the end of the second year. Conversely, researchers found that patients taking ARBs only had the intestinal malabsorption incidence rate of 1.5 cases per 100,000 person-years after 2 years. Just 0.9 cases per 100,000 person-years were found in patients on an ACE inhibitor after 2 years.

Benicar® was approved by the U.S. Food and Drug Administration (FDA) in April 2002 for the treatment of hypertension to lower blood pressure. The FDA reports that a total of approximately 10.6 million prescriptions were dispensed in 2012, and approximately 1.9 million patients received a dispensed prescription from retail pharmacies.

In July 2013, the FDA issued a Drug Safety Communication warning that Benicar® could cause severe intestinal damage known as sprue-like enteropathy. The agency required immediate label changes to include this concern.

Prior to the FDA warning, in June 2012 researchers at the Mayo Clinic in Rochester, Minnesota published a case series in Mayo Clinic Proceedings reporting their findings in response to discontinuing Benicar® in patients with unexplained severe sprue-like enteropathy. In particular, the study included 22 hospital patients who presented to the Mayo Clinic with unexplained chronic diarrhea, weight loss and enteropathy. Doctors at the Mayo Clinic discovered that all 22 patients had something in common – they were each taking Benicar® to control their blood pressure. The doctors then asked the patients to discontinue their use of Benicar®, and after discontinuing Benicar®, the researchers discovered that the patients’ symptoms of chronic diarrhea, weight loss and vomiting improved.

“We will fight for the rights of individuals who allege to have experienced serious gastrointestinal injuries after using Benicar®,” says Kristine Kraft of Schlichter, Bogard & Denton, LLP. She adds, “The attorneys at Schlichter, Bogard & Denton, LLP are offering free and confidential case reviews to those who allege to have been injured after using Benicar®.”


About Schlichter, Bogard & Denton, LLP 

Schlichter, Bogard & Denton, LLP is a unique law firm that has held numerous leadership positions in national litigations involving dangerous pharmaceutical medications and unsafe medical devices, including but not limited to: In re: Pradaxa® (Dabigatran Etexilate) Products Liability (MDL 2385, Case No. 12-md-2385, S.D. Ill.), In re: Yasmin® and Yaz® (Drospirenone) Marketing and Sales Practices and Products Liability Litigation (MDL 2100, Case No. 09-md-2100, S.D. Ill.), In re: NuvaRing® Products Liability Litigation (MDL 1964, Case No. 08-md-1964, E.D. Mo.), In re: Gadolinium-Based Contrast Products Liability Litigation (MDL 1909, Case No. 08-gd-50000, N.D. Ohio), and In re: Ortho Evra® Products Liability Litigation (MDL 1742, Case No. 06-gd-40000, N.D. Ohio).

The Pharmaceuticals and Medical Litigation Department at Schlichter, Bogard & Denton, LLP aggressively represent clients who allege to have suffered injuries as a result of dangerous pharmaceutical medications and unsafe medical devices. The attorneys at Schlichter, Bogard & Denton, LLP who represent such victims include Roger Denton, Kristine Kraft, Beth Wilkins Flieger, Ashley Brittain Landers, and Tara Rocque. With hard work, creative thinking, and strong trial skills, we have earned an outstanding nationwide reputation by representing thousands of individuals who have suffered serious and life-threatening injuries, or even death.

If you or a loved one has suffered serious gastrointestinal injuries after using Benicar®, please contact the attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.

Schlichter, Bogard & Denton, LLP also welcomes the opportunity to work with other attorneys on these types of cases. Schlichter, Bogard & Denton, LLP is available to either handle these cases or work as co-counsel, so other attorneys with these types of cases are invited to contact an attorney at the firm to explore this opportunity.


The choice of a lawyer is an important decision and should not be based solely on advertisements. The cases discussed do not predict outcomes in future cases. Past results afford no guarantee of future results and every case is different and must be judged on its own merits.

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