Missy Clyne Diaz  |  October 17, 2014

Category: Legal News

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benicar

A federal judge in California has issued an order stipulating how to handle certain confidential and protected information in the case of a woman and her husband who are suing the manufacturer of the blood-pressure drug Benicar.

In June, Susanne Ambler’s Benicar lawsuit against Daiichi Sankyo was transferred to the Southern District of California. Ambler began taking the recommended dose of the blood-pressure medication after her San Diego doctor prescribed it within the last four years.

According to the Benicar lawsuit, she suffered something known as sprue-like enteropathy and/or lymphocytic colitis, microscopic colitis, or collagenous colitis, which is manifested by chronic diarrhea, severe weight loss, nausea, vomiting, malnutrition, and dehydration.

She blames the Benicar side effects — and the manufacturer’s failure to warn of its risks — for causing her to have extended hospital stays for sprue-like enteropathy and related issues. Studies have shown that symptoms can begin months or even years after taking the medication.

In 2012, the Mayo Clinic published an article finding a nexus between Benicar and sprue-like enteropathy. The study led to the FDA’s July 2013 decision to require that the label warns patients about the risk of severe sprue-like enteropathy caused by olmesartan, an ingredient in Benicar, Benicar HCT, Azor, Tribenzor, and generic.

The Benicar side effects were characterized as “life-threatening” in that more than half of the patients required hospitalization for extreme weight loss caused by the Benicar side effects of diarrhea.

Some 23 cases of people suffering late-onset diarrhea and significant weight loss, and in some cases, intestinal villous atrophy on biopsy, were reported. Intestinal villous atrophy is when there is decaying in a part of the intestinal tract, making it difficult for the body to absorb nutrients, resulting in chronic dehydration, malnutrition and a weakened immune system.

Symptoms of sprue-like enteropathy closely mirror celiac disease, which is an intolerance to gluten. Common symptoms include severe and/or chronic diarrhea, substantial weight loss and an electrolyte imbalance.

Shortly after the Mayo Clinic study, researchers from the American College of Gastroenterology reported 40 additional cases of olmesartan-related sprue-like enteropathy.

Other Benicar side effects include eye pain and vision problems, chest pain, shortness of breath, fever, swelling, sudden weight gain, decrease in urination, jaundice, dry mouth, drowsiness, confusion and seizures.

Doctors write more than 11 million prescriptions annually for the hypertension medication, which was approved by the FDA for commercial sale in April 2002. It is the most widely prescribed blood pressure medication in the country.

The blood pressure medicine is the subject of numerous Benicar lawsuits around the country, many filed by people first diagnosed with celiac disease before figuring out Benicar was the problem. Plaintiffs are asking for compensation for medical bills, pain and suffering, and sometimes permanent injuries to their intestines.

Ambler’s Benicar lawsuit is expected to go to trial sometime in early 2016.

The Benicar Lawsuit is Susanne Ambler, et al. v. Daiichi Sankyo Inc., et al. Case No. 3:14-cv-01475-WQH-BLM, in the U.S. District Court for the Southern District of California.

In general, Benicar lawsuits are filed individually by each plaintiff and are not class actions.

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