The U.S. Food and Drug Administration (FDA) has warned the public that the blood pressure drug olmesartan medoxomil—sold under the brand names Benicar, Benicar HCT, Azor, and Tribenzor—might cause an intestinal problem called “sprue-like enteropathy.”
Benicar is a popular drug, originally patented by the Japanese pharmaceutical company Daiichi Sankyo. In 2010, more than six million Benicar prescriptions—worth more than $550 million—were filled. In 2012, 10.9 million Benicar prescriptions were dispensed to 1.9 million users.
The FDA believes that Benicar might cause an intestinal problem known as sprue-like enteropathy, a condition that is similar in character to Celiac disease. Symptoms include:
- severe diarrhea
- chronic diarrhea (symptoms that don’t stop over time)
- substantial weight loss
- villous atrophy (erosion of the villi, the hair-like lining of the small intestines that absorb food into the body)
As of October 2015, more than 1,000 Benicar lawsuits had been filed in U.S. courts on behalf of patients who had allegedly developed sprue-like enteropathy related to their use of the medication. In April 2015, all federally-filed Benicar cases were centralized in a multidistrict litigation and transferred to the U.S. District Court, District of New Jersey. On the state level, dozens of additional lawsuits were consolidated in a multicounty litigation now underway in New Jersey’s Atlantic County Superior Court. No Benicar settlements have yet been announced, but the federal litigation has scheduled a number of depositions for early 2016.
One FDA Study Found a Clear Association Between Benicar and Sprue-Like Enteropathy
In a July 2013 drug safety communication, the FDA announced its conclusion that Benicar might cause sprue-like enteropathy after investigating 23 adverse event reports of patients who had been diagnosed with the condition after having taken the drug. The agency found that symptoms of sprue-like enteropathy can develop months or years after Benicar use begins. Some of the 23 users required hospitalization, but when they discontinued using the drug all patients reported improvement. The FDA believes that delayed hypersensitivity to the drug in the intestines or a cellular immune response are the possible reasons for the long latency period between initial use of the drug and development of symptoms of sprue-like enteropathy.
A year earlier, researchers at the Mayo Clinic had published a case series identifying 22 other people who took Benicar and developed sprue-like enteropathy. Of the 18 patients who had follow-up biopsies of their intestines after discontinuing Benicar treatment, all of them showed signs of improvement.
How Can a Lawsuit Help Me?
If you or a loved one took Benicar and you believe it caused sprue-like enteropathy, a lawsuit can help you hold the manufacturer accountable. The amount of compensation from a Benicar lawsuit can include damages for full medical expenses, lost earnings, pain and suffering, and other damages. The process begins by talking about what happened with a lawyer from the Rottenstein Law Group. If you have any questions about your situation, call 1 (888) 976-8529 or click on this link.