Link Between Benicar and Severe Enteropathy Confirmed in New Study

A new French survey provides further evidence linking the side effects of Benicar, a hypertension drug, to cases of severe enteropathy, which may cause users to experience chronic diarrhea for years and can lead to permanent gastrointestinal damage.  

In a study published earlier this month in the medical journal Alimentary Pharmacology and Therapeutics, researchers outlined the results of a new survey that demonstrates a strong association between the use of Benicar or other olmesartan-based blood pressure medications, and cases of enteropathy.

Benicar is a widely used blood pressure medication, which is part of a family of medications that all contain olmesartan as the active pharmaceutical ingredient, with other related drugs including Benicar HCT, Azor and Tribenzor.

Although the drug has been on the market for more than a decade, it was not until recently that the medical community became aware of the link between Benicar and enteropathy problems, where users may experience chronic diarrhea, weight loss and other gastrointestinal issues that may surface years after they begin using the medication.

Formally known as sprue-like enteropathy, many doctors have not recognized the connection between the medication and the Benicar symptoms, resulting in consumers continuing to use the blood pressure medication and increasing the risk of permanent intestinal damage.

In an effort to confirm or refute the causal connection between the medication and gastrointestinal events, as well as to determine if the same association is seen with similar blood pressure drugs, researchers collected clinical, biological and histological data on sartan-associated enteropathy cases.

Researchers indicate that 36 cases of Benicar-associated enteropathy were reported, leading to the conclusion that the active ingredient olmesartan causes severe and immune-mediated enteropathy, which is only rarely seen with other sartans.

In all but four of the cases, the individuals also suffered from villous atrophy after using Benicar, which involves long-term damage to the gastrointestinal tract that causes food intolerance and other digestive problems.

The researchers reported that patients showed symptoms including diarrhea, vomiting, kidney failure, weight loss and other side effects. In 31 cases, patients had to be hospitalized, with four requiring intensive care.

“Olmesartan causes a severe and immune-mediated enteropathy, with or without villous atrophy,” the researchers concluded. They found no such link with similar drugs.

Benicar Enteropathy Risk

The first reports suggesting a link between Benicar and enteropathy symptoms was published in July 2012, when independent researchers from the Mayo Clinic identified a number of cases involving patients with symptoms similar to Celiac disease treated at clinics nationwide.

Researchers outlined cases involving at least 22 patients from 17 different states who were treated for symptoms consistent with celiac disease while taking Benicar.

While treatments for celiac disease were ineffective, the report published in the medical journal Mayo Clinic Proceedings found that once patients stopped taking Benicar, their symptoms of chronic diarrhea and intestinal problems resolved. However, the study was not widely reported, and many primary care physicians remained unaware of the potential risk associated with Benicar.

In July 2013, the FDA issued a drug safety communication on the issue, providing widespread information to the medical community for the first time about the risk of sprue-like enteropathy from Benicar.

The federal drug regulators indicated that they found “clear evidence” of a cause and effect relationship between the drug and the gastrointestinal problems, with issues often stopping when the medication was no longer used and resuming if the treatment restarts.

As more users learn that enteropathy problems experienced for years may be caused by their blood pressure medication, a growing number of Benicar lawsuits are now being filed in courts throughout the United States. The lawsuits allege that the drug makers knew or should have known about this potential risk associated with their blockbuster medication, and withheld information from consumers and the medical community for decades.