Benicar Side Effects Induce Intestinal Response Similar to Gluten for Celiac Disease Patients: Study

A new study that was designed to determine why the side effects of Benicar cause sprue-like enteropathy, resulting in chronic diarrhea and potential intestinal damage for users, found that the hypertension drug appears to affect people with relatively normal digestive systems in the same way that gluten affects those suffering from Celiac disease. 

Doctors and scientists from the Mayo Clinic report that it is understandable why doctors failed to recognize the risk of Benicar-induced enteropathy for years, often misdiagnosing patients as suffering from Celiac disease (also known as Coeliac disease); because the two conditions are are extremely similar.

The findings were published online October 1 in the medical journal Alimentary Pharmacology and Therapeutics.

Benicar (olmesartan medoxomil) is part of a family of Daiichi Sankyo hypertension drugs, which also includes Benicar HCT, Azor and Tribenzor. All of the blood pressure drugs include the active ingredient olmesartan, which has been linked to the development sprue-like enteropathy, causing severe diarrhea and weight loss that may surface months or even years after first use of the drug.

As a result of the lack of warnings provided by the drug makers about the potential link between Benicar and diarrhea problems, many users have been repeatedly hospitalized in recent years as doctors struggled to identify the potential cause of their gastrointestinal issues.

The Benicar problems have often been misdiagnosed as Celiac disease or unclassified sprue, resulting in continued use of the medication, increasing the risk that users may suffer long-term intestinal damage.

Although the diarrhea symptoms associated with sprue-like enteropathy typically resolve when the medication is no longer used, the problems can cause permanent damage to the intestines, known as villous atrophy from Benicar.

Mayo Clinic researchers, who first discovered that Benicar was responsible for cases of undiagnosed or improperly diagnosed sprue in 2012, went back to see if they could find the mechanism of action for the drug and to see if they were as similar to Celiac disease as they appeared to be.

According to the findings, they were.

Researchers extracted biopsies from 11 patients before they stopped taking Benicar, and 17 others after the medication was discontinued. The findings indicate that the patients’ bodies were responding similarly to what is seen among patients with Celiac disease.

In both cases of Benicar enteropathy and Celiac disease, there is a significant increase in what are known as CD8+ cells, causing the body to respond negatively to some substances’ presence. In the case of Celiac disease, that substance is gluten. In the case of Benicar users, it’s the drug itself.

“Olmesartan-associated enteropathy shares many features with coeliac disease, including symptoms and immunopathogenic pathways, such as increased numbers of CD8+ cells and corresponding overexpression of IL15 by epithelial cells,” the researchers concluded. “Taken together, the treatment of epithelial cells with olmesartan medoxomil induces a response by intestinal epithelial cells that is similar to the innate effects of gluten upon the epithelium of coeliac patients.”

The epithelium is the tissue that lines the inner surface of organs, blood vessels and cavities of the body.

Benicar Lawsuits

The findings come as a growing number of Benicar lawsuits continue to be filed against Daiich Sankyo and Forest Laboratories, alleging that the drug makers knew or should have known about the side effects caused by their medication, yet withheld warnings from consumers and the medical community.

The litigation has emerged since the FDA issued Benicar warnings about the risk of sprue-like enteropathy in July 2013, providing information to physicians for the first time that problems similar to Celiac disease may be caused by the hypertension drug.

Plaintiffs allege that they may have avoided severe and on-going gastrointestinal problems, such as chronic dehydration and malnutrition, if warnings had been provided about the risk that Benicar side effects may cause chronic diarrhea.

Since April 2015, the Benicar litigation pending throughout the federal court system has been centralized before U.S. District Judge Robert Kugler in the District of New Jersey, as part of a federal MDL or multidistrict litigation. Similar centralized proceedings have been established in New Jersey state court.