The Senators (Ret.) Firm, LLP is currently investigating reports of gastrointestinal injuries associated with the blood pressure drug, Benicar (also marketed as marketed as Benicar HCT, Azor, Tribenzor, and generic olmesartan medoxomil). Contact a defective drug lawyer in California at (949)-557-5800. Our California Benicar attorneys are here to help.
California Law Firm Handling Defective Drug Lawsuits
The FDA approved this drug in 2002 for the treatment of high blood pressure. It belongs to a class of medications called angiotensin receptor blockers. The Senators Firm has decades of experience litigating thousands of product liability claims involving injuries from prescription medications, including drugs that cause gastrointestinal side effects.
Benicar may Cause a Serious Intestinal Disorder called Sprue-like Enteropathy
Benicar may Cause a serious digestive system disease called “sprue-like enteropathy.” Celiac sprue, also known as celiac disease or gluten-sensitive enteropathy, is a chronic disorder of the digestive tract that results in an inability to tolerate substances contained in gluten, a protein commonly found in wheat, rye, and barley. When patients with celiac sprue ingest gluten (in bread and other foods), an inflammatory response occurs that damages tissues in the lining their intestines, resulting in decreased digestion, diarrhea, and weight loss.
A link between Benicar and a severe intestinal disease that appears to mimic celiac sprue was first reported reported by researchers at the Mayo Clinic in 2012. Doctors there identified 22 patients with severe sprue-like enteropathy associated with use of Benicar seen at the Mayo Clinic between August 2008 and 2011. All of the patients had chronic unexplained diarrhea and a median weight loss of 40 pounds. Hospitalization was required in 14 cases and food tube feedings in four. The patients had not responded to a gluten-free diet, so celiac disease was ruled out in all the cases.
The patients in the Mayo Clinic study had all received Benicar for treatment of hypertension (high blood pressure), and all of the patients had used the drug for at least a year before developing symptoms. Some of the patients had taken the drug for more than 3 years prior to the onset of their disease. Strikingly, the duration of illness in these patients, which included chronic diarrhea, nausea, vomiting, abdominal pain, and bloating. These illnesses reportedly lasted an average of 19 months, with some cases lasting 53 months.
In October of 2012, researchers at the American College of Gastroenterology meeting presented data documenting another 44 cases of sprue-like enteropathy associated with Benicar.
Warnings and Label Changes for Benicar Required by FDA in July 2013
Despite growing evidence of a link between Benicar and serious intestinal disease, the product’s manufacturer, Japan-based Daiichi Sankyo, disputed the significance of the Mayo Clinic and other data.
FDA began to review the published data as well as its own collection of “adverse experience reports” for Benicar. What is found was “clear evidence of an association between Benicar and sprue-like enteropathy.” On July 3m 2013, FDA issued a safety alert to doctors and patients which warned about this serious side effect. FDA also required the manufacturer of the drug to modify its labeling to better warn clinicians about the risk of enteropathy.
Experienced Prescription Drug Injury Lawyers at The Senators (Ret.) Firm, LLP
The lawyers at The Senators Firm have decades of experience litigating high-stakes products liability cases involving prescription drugs all over the country. We have the knowledge to quickly evaluate your potential Benicar case and to provide you with aggressive and effective representation in order to gain maximum compensation. If you or a loved one believe you or they may have been injured by a side effect to Benicar, call us toll free 24 hours a day at (949)-557-5800. Or, contact our California Benicar attorneys through this website.