Benicar Warnings About Diarrhea, Enteropathy Withheld by Makers: Lawsuit

A recently filed product liability lawsuits alleges that Daiichi Sankyo and Forest Laboratories failed to adequately warn about the risk of sprue-like enteropathy from Benicar, claiming that an Ohio woman suffered long-term diarrhea and other gastrointestinal injuries because information about the potential side effects were withheld from consumers and the medical community.

The complaint (PDF) was filed against the drug makers by Laura J. Laney on November 14, in U.S. District Court for the Northern District of Ohio.

Laney indicates that side effects of Benicar caused her to suffer chronic diarrhea, rapid weight loss, nausea, vomiting, malnutrition, dehydration, and kidney failure, which resulted in multiple hospitalizations and have left her with permanent injuries that require on-going treatment and monitoring.

According to allegations pursued against the drug makers, if more accurate information and warnings had been provided with Benicar, Laney may have been able to avoid suffering long-term injury. As a result of intestinal damage caused by Benicar, Laney indicates that she now must undergo regular monitoring, screening, testing and treatment.

Link Between Benicar and Enteropathy

Benicar (olmesartan medoxomil) is one of a family of Daiichi Sankyo hypertension drugs, which also includes Benicar HCT, Azor and Tribenzor. All of the blood pressure drugs include the active ingredient olmesartan, which has been linked to the development sprue-like enteropathy.

Although the medication has been on the market for more than 10 years, the first Benicar warnings about the risk of sprue-like enteropathy were not provided until June 2013, when the FDA issued a drug safety communication indicating that side effects of the medication may cause symptoms like diarrhea and other intestinal problems to develop months or even years after first use of the drug.

Many Benicar users are now discovering that they have been fighting chronic diarrhea problems from Benicar for years, without understanding the underlying cause of the issues, resulting in unnecessary medical treatments, repeated hospitalization and often leaving former users with permanent damage to their intestines.

In many cases, the Benicar problems have been misdiagnosed as Celiac disease or unclassified sprue, resulting in continued use of the medication, which could leave users with long-term intestinal damage.

Although the diarrhea symptoms associated with sprue-like enteropathy typically resolve when the medication is no longer used, the problems can cause permanent damage to the intestines, known as villous atrophy from Benicar.

Laney’s complaint is one of a growing number of Benicar lawsuits, Azor lawsuits and Tribenzor lawsuits filed in recent months over the failure to warn about the risk of enteropathy problems. Laney is pursuing claims for efective design, failure to warn, strict liability, breach of warranty, negligence and gross negligence, negligent misrepresentation, fraudulent concealment, failing to meet federal drug safety standards, fraud, and civil conspiracy, seeking both compensatory and punitive damages