Azor Lawsuit Filed Over Chronic Diarrhea, Sprue-Like Enteropathy Side Effects

As a growing number of Benicar lawsuits continue to be filed by former users of the blood pressure drug who have suffered chronic diarrhea or other symptoms of sprue-like enteropathy, an Iowa woman indicates that she has suffered the gastrointestinal problems from Azor, a related blood pressure medication that contains the same pharmaceutical ingredient.

The Azor lawsuit (PDF) was filed by Kalawatti Kay Scheffler and her husband, James, in the U.S. District Court for the Southern District of Iowa on November 6, naming Daiichi Sankyo and Forest Laboratories as defendants.

Azor is a hypertension drug that combines the active ingredient in Benicar with amlodipine, which is a calcium channel blocker that was sold under the brand name Norvasc.

According to allegations raised in the complaint, side effects of Azor caused Scheffler to develop sprue-like enteropathy, which is a medical condition associated with chronic diarrhea, weight loss and malnutrition.

Scheffler indicates that she was presribed Azor in January 2011, but did not realize the blood pressure drug was causing her to experience the chronic and debilitating diarrhea and abdominal pain, since the drug makers failed to adequately warn consumers and the medical community.

While symptoms of the Azor enteropathy problems typically resolve when the medication is no longer used, sprue-like enteropathy can result in a permanent and debilitating condition known as villous atrophy, which involves degradation of the villi lining the small intestines and can lead to digestion problems and food intolerances similar to Celiac disease.

Scheffler indicates that she now has medical problems that require regular monitoring and that she will have to undergo screening, testing, and treatment for life due to the drug makers’ failure to warn about the potential Azor side effects.

Failure to Warn About Azor Side Effects

Azor (amlodipine besylate and olmesartan medoxomil) was approved by the FDA in 2007 for the treatment of hypertension alone or in combination with other blood pressure drugs. It is part of the Benicar family of drugs sold by Daiichi Sankyo and Forest Laboratories.

Other Benicar drugs sold by the pharmaceutical companies containing olmesartan include Benicar HCT and Tribenzor, which have all been linked to a potential risk of sprue-like enteropathy.

Although Benicar has been on the market for more than 10 years, the first 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 drugs that contain olmesartan.

Many users of Benicar, Azor and Tribenzor are now discovering that they have been fighting chronic diarrhea problems for years that may have been caused by olmesartan, often resulting in unnecessary medical treatments, repeated hospitalization and 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.

According to the lawsuit filed by Scheffler, she indicates that she has suffered life-threatening physical injuries, emotional and mental trauma, and significant medical expenses due to Azor side effects.

The complaint joins a growing number of lawsuits over Benicar, Azor and Tribenzor filed by individuals throughout the United States, which have been brought since Daiichi Sankyo and Forest were forced to add label warnings about these potential side effects last year.

Scheffler is pursuing claims against the drug makers for designing a defective drug, failure to warn, gross negligence, negligence, fraudulent concealment, fraud, violating consumer protection laws, and unjust enrichment. Her husband is suing for loss of consortium. The lawsuit seeks both compensatory and punitive damages.