Benicar Side Effects Include Sprue-Like Enteropathy, Diarrhea

Carl EvansDefective Drugs

Benicar Side Effects Include Sprue-Like Enteropathy

Benicar Sprue-Like Enteropathy Causes Intestinal Problems

One potential side effect of Benicar, a drug used to treat high blood pressure, is sprue-like enteropathy. Symptoms of sprue-like enteropathy include intestinal symptoms, including chronic diarrhea, nausea, abdominal pain, weight loss and malnutrition. The safety label on Benicar and related drugs was updated in 2013 to warn about the risk of sprue-like enteropathy. Daiichi Sankyo and Forest Laboratories, who market Benicar, are facing lawsuits alleging that the companies failed to warn patients and the medical community about the risks.

The product liability attorneys at Parker Waichman LLP have decades of experience representing clients in lawsuits involving drug side effects. The firm continues to offer free legal consultations to individuals with questions about filing a Benicar lawsuit.

In a July 2013 Drug Safety Communication, the FDA warned that Benicar, Benicar HCT, Azor, Tribenzor, and generics may lead to sprue-like enteropathy, which leads to intestinal symptoms causing “severe, chronic diarrhea with substantial weight loss” regulators said.

Intestinal side effects from Benicar may not occur immediately. The FDA said that symptoms of sprue-like enteropathy may appear months or years after starting the medication. “If patients taking olmesartan develop these symptoms and no other cause is found, the drug should be discontinued, and therapy with another antihypertensive started.” regulators said.

“Discontinuation of olmesartan has resulted in clinical improvement of sprue-like enteropathy symptoms in all patients.”

The FDA reviewed its Adverse Event Reporting System (FAERS) and found 23 cases where patients developed late-onset diarrhea and significant weight loss associated with Benicar. In some cases, biopsy revealed intestinal villous atrophy. The agency said symptoms improved in all patients once they stopped taking the drug. In 10 patients, symptoms re-emerged when they resumed taking Benicar (this is known as positive rechallenge).

The intestines contain microscopic, finger-like projections known as villi, which are responsible for absorbing nutrients following digestion. Villous atrophy wears away these structures, impairing the body’s ability to obtain nutrients from food. Celiac disease is a common cause of villous atrophy. Benicar can also cause villous atrophy.

Regulators said they reviewed cases of sprue-like enteropathy and Benicar from several different sources, including published literature. “FDA’s evaluation found clear evidence of an association between olmesartan and sprue-like enteropathy.” the agency said.

Cases of sprue-like enteropathy associated with Benicar use were also documented by Mayo Clinic researchers in 2012. The FDA noted that symptoms in these 22 patients were similar to those reported in the adverse event database. “Patients in the Mayo Clinic case series developed diarrhea, weight loss, and villous atrophy while on olmesartan, and drug discontinuation resulted in clinical improvement. Eighteen patients had follow-up intestinal biopsies histologically demonstrating recovery or improvement of the duodenum after discontinuation of olmesartan.” FDA said.

In 2013, the American Journal of Gastroenterology published a study focusing on patients with villous atrophy who tested negative for celiac disease. In some patients with unclassified villous atrophy (VA), it was later discovered that symptoms were caused by using Benicar (known by its generic name as olmesartan). The authors concluded “The role of medications in the development of VA and the optimal dose and length of immunosuppression for patients with US [unclassified sprue] should be investigated further.”

Benicar Lawsuits Allege Drug Makers Failed to Warn of Diarrhea, Malnutrition

Parker Waichman notes that the Benicar litigation continues to move forward, as federal lawsuits have been consolidated into a multidistrict litigation (MDL). Benicar lawsuits are filed on behalf of individuals who suffered sprue-like enteropathy and subsequent intestinal symptoms, which include diarrhea, nausea, abdominal pain, colitis and other related symptoms. Plaintiffs allege that Daiichi Sankyo and Forest Laboratories were aware of these adverse events but never disclosed this information to patients or their physicians.

Court records indicate that one Benicar intestinal side effects lawsuit was filed on behalf of an Oklahoma woman. The woman started taking Benicar in 2013 to control her high blood pressure and reduce the risk of a serious cardiovascular event. The complaint states that neither she nor her physician knew about the risk of sprue-like enteropathy with Benicar at the time. The plaintiff developed nausea, diarrhea, abdominal pain, malabsorption, malnutrition, villous atrophy, sprue-like enteropathy, colitis and dehydration, allegedly due to Benicar use. These complications forced her to undergo emergency intervention, resulting in substantial medical bills, the suit alleges. The plaintiff alleges that she would have chosen a different treatment option if Daiichi Sankyo and Forest Laboratories adequately warned about the risks.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has consolidated federal Benicar sprue-like enteropathy lawsuits into a multidistrict litigation (MDL). The JPML creates MDLs, a type of mass tort, to make complex litigation faster and more efficient. Transferring lawsuits with common questions of fact to one court before one judge eliminates duplicate discovery and streamlines legal proceedings. Unlike a class action lawsuit, where one lawsuit represents numerous plaintiffs against a common defendant, lawsuits remain separate in an MDL.

Benicar Side Effects Include Sprue-Like Enteropathy

Benicar Side Effects Include Sprue-Like Enteropathy

U.S. District Judge Robert Kugler is presiding over the Benicar MDL in New Jersey. The first cases selected for trial in an MDL are known as “bellwether cases”, where both parties try out their legal arguments in court for the first time. These cases are used to get a sense of how the remaining litigation would proceed. For example, if juries award large verdicts to plaintiffs in bellwether trials, drug makers may be more inclined to settle lawsuits instead of seeing them through to trial.

In the Benicar MDL, bellwether trials are slated to begin sometime in 2017. The original target date was for late 2016, but pretrial motions appear to be running until at least Mar. 31, 2017. According to court records, at least 1,700 lawsuits have been filed into the Benicar MDL. Lawsuits have also been filed in New Jersey state court before Superior Court Judge Nelson Johnson.

Plaintiffs in the Benicar litigation allege chronic diarrhea and other intestinal symptoms. In some cases, the drug allegedly caused patients to suffer diarrhea 10 or 20 times a day, leading to severe weight loss of 75 to 100 pounds. Lawsuits allege that these intestinal symptoms caused them to be malnourished.

Filing a Benicar Lawsuit

If you or someone you know has questions about filing a Benicar lawsuit, contact Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).