In the summer of 2013, the FDA mandated changes to the labeling of the drug Benicar, based on the revelation that it  could cause sprue-like enteropathy.

Sprue-like enteropathy describes a constellation of symptoms seen in patients with celiac disease, IBS, and related disorders. This includes painful bloating and chronic diarrhea. These celiac disease symptoms experienced by many Benicar users can be mild enough to be a minor inconvenience or severe enough to be debilitating.

The FDA based the decision to add the warning to Benicar’s label based on research presented at the American College of Gastroenterology meeting in October 2012. In this presentation, researchers from the Mayo Clinic stated that they had found 22 patients who appeared to be suffering from sprue-like enteropathy. However, blood tests did not find the chemical markers usually seen in patients with sprue-like enteropathy. When physicians noticed that all of the patients in question were taking Benicar, doctors took them off the drug, and all of the patients’ celiac disease symptoms cleared up. The patients had suffered through their sprue-like enteropathy for an average of 19 months. Most had lost so much weight that when the drug was taken away, they gained an average of 27 pounds each.

Based partially on this presentation, as well as data and research papers from other sources, the FDA has mandated changes to Benicar’s labeling to warn patients of the risk of suffering sprue-like enteropathy or celiac disease symptoms. The group of closely-related disorders like villous atrophy, IBS, celiac disease, and others typically improve with a strict diet. However, a subset of patients with these diseases do not respond to changes in diet or other treatments, leaving them to suffer through symptoms like chronic diarrhea. This could mean that patients with mysterious sprue-like enteropathy symptoms might not have many options. However, the revelation that Benicar may be behind some of these symptoms may mean that patients could have suffered for months when changing blood pressure medication could have fixed the problem.

Benicar lawsuits have been filed by patients suffering from sprue-like enteropathy after taking the drug. These lawsuits allege that the makers of Benicar were aware — or reasonably should have been aware — of the risk of sprue-like enteropathy associated with Benicar. The lawsuits further allege that not only were drug makers aware of these risks, but they failed to disclose them to the public, leading to months of painful symptoms like chronic diarrhea that could have been avoided. Benicar lawsuits typically seek compensation for medical costs, pain and suffering, and other expenses related to sprue-like enteropathy allegedly caused by Benicar.