The FDA recently warned that Benicar, a widely-prescribed hypertension drug, may cause a severe gastrointestinal side effect known as sprue-like enteropathy. Symptoms of this condition include chronic diarrhea and substantial weight loss. People who suffered these side effects after taking Benicar may be eligible to file a lawsuit against Daiichi Sankyo, the drug’s manufacturer.
Free Confidential Lawsuit Evaluation: If you or a loved one was diagnosed with enteropathy after taking Benicar (olmesartan), you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.
What are the Symptoms of Sprue-Like Enteropathy?
On July 3, 2013, the FDA issued a Drug Safety Communication entitled “FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil [(e.g., Benicar, Benicar HCT, Azor, and Tribenzor)]. The communication began by stating that the agency had approved label changes to these drugs to include verbiage indicating that they may cause severe gastrointestinal (GI) intestinal problems.
The updated Warnings and Precautions section of Benicar labels now reads:
5.5 Sprue-like Enteropathy
Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider discontinuation of Benicar in cases where no other etiology is identified.
Previously, Benicar drug labels included a mention of diarrhea in the Adverse Reactions section. According to the July 2013 FDA warning:
“In 2012, a total of approximately 10.6 million prescriptions were dispensed, and approximately 1.9 million patients received a dispensed prescription for olmesartan-containing products from U.S. outpatient retail pharmacies.”
Additionally, FDA stated that it will continue to evaluate the safety of olmesartan-based blood pressure medications such as Benicar, Benicar HCT, Azor, and Tribenzor.
Status of Benicar Litigation
Daiichi Sankyo released Benicar in 2002, but it wasn’t until July 2013 that the FDA warned that the drug may cause enteropathy. Benicar users diagnosed with the condition began filing lawsuits soon after the warning was issued.
Some of the first Benicar lawsuits against Daiichi were filed in New Jersey state court in February of 2014. Judges then transferred the cases to the federal court system. Experts expect many more lawsuits to follow in the coming weeks and months.
According to these complaints, many Benicar users with sprue-like enteropathy might not realize the drug is to blame. Symptoms caused by Benicar may be mistaken for celiac disease or other intestinal problems.
Do I have a Benicar Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Benicar lawsuits. We are handling individual litigation nationwide and currently accepting new Benicar Enteropathy cases in all 50 states.
Free Benicar Lawsuit Evaluation: If you or a loved one was diagnosed with enteropathy after taking Benicar, you should contact our law firm immediately. You may be entitled to compensation by filing a Benicar Suit and our lawyers can help.