Answers to Frequently Asked Questions (FAQ) about Benicar, a blood pressure drug that has been linked to chronic diarrhea and sprue-like enteropathy.
Need a Texas Benicar Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with enteropathy, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Frequently Asked Questions
What is sprue-like enteropathy?
What are the symptoms of sprue-like enteropathy?
What are the complications of sprue-like enteropathy?
Does Benicar cause Celiac disease?
Is diarrhea a rare side effect of Benicar?
Benicar® is the brand-name for olmesartan medoxomil. It is a blood pressure drug made by Daiichi Sankyo that was approved by the FDA in 2002. Benicar HCT® was approved in 2003.
Benicar contains olmesartan, an Angiotensin II Receptor Blocker (ARB). It relaxes muscles surrounding blood vessels, which widens them to reduce blood pressure.
Benicar HCT combines olmesartan and hydrochlorothiazide, a diuretic that helps the body eliminate water. It reduces the volume of blood and makes it easier for the heart to pump blood into the body.
The most common side effects experienced by at least 2% of patients are nausea, hyperuricemia (excess uric acid in blood), dizziness, and upper respiratory infection.
The most serious side effects of Benicar include:
- Sprue-like enteropathy
- Low blood pressure (hypotension)
- Fluid or electrolyte imbalance
- Kidney problems
- Liver impairment in patients with liver disease
- Fetal toxicity during pregnancy
- Allergic reactions
Mayo Clinic researchers were the first to publish case studies linking Benicar and sprue-like enteropathy. The study was published in Mayo Clinic Proceedings in August 2012.
Dr. Joseph Murray observed 22 patients who developed chronic diarrhea and weight loss between 2008 and 2011.
The patients had symptoms resembling Celiac disease, but they did not improve on a gluten-free diet. When the patients discontinued Benicar, all of them improved.
No deliberate re-challenge test was undertaken because of the life-threatening nature of sprue-like enteropathy, but two patients reported that their symptoms worsened when they restarted Benicar.
Yes. On July 3, 2013, the FDA issued a Safety Communication after finding “clear evidence” linking Benicar and sprue-like enteropathy. The FDA identified 23 serious cases in their adverse event database.
In January 2006, the FDA issued a Warning Letter (PDF) to Daiichi Sankyo for “false and misleading” advertisements for Benicar that claimed it was superior to other blood pressure drugs without sufficient evidence.
Sprue-like enteropathy is a potentially life-threatening digestive disease that causes chronic gastrointestinal inflammation and diarrhea. Over time, it destroys the lining of the upper intestines and causes malnutrition and problems digesting food.
- Diarrhea (frequent and watery)
- Severe weight-loss
- Loss of appetite
- Intestinal damage
- Villous atrophy
- Abdominal pain
Villous atrophy is a permanent intestinal damage involving villi, which are tiny finger-like tentacles lining the upper intestines.
Over time, sprue-like enteropathy causes villi to erode away, leaving flat spots on the intestine that do not absorb nutrients from food into the bloodstream. This can result in severe weight-loss and malnutrition.
There have also been case reports of colon perforation, including a 52 year-old woman who had diarrhea 20 times per day for a year and lost 45 pounds within 6 months.
No. Patients on Benicar are often misdiagnosed with Celiac disease (also known as “sprue”) because the symptoms are similar, but it is not caused by gluten intolerance. Patients will only improve when they stop Benicar.
The FDA issued warnings based on only a few dozen cases, but because many patients were misdiagnosed it is likely that cases were not reported. In 2014, researchers said it “may not be rare” after observing five cases in one small gastroenterology unit.
As of August 15, 2016, there were 1,694 federal lawsuits pending against Daiichi Sankyo. The cases are centralized in New Jersey under U.S. District Judge Robert B. Kugler in Multi-District Litigation (MDL No. 2606) — In Re: Benicar (olmesartan) Products Liability Litigation.
The time-limit to file a lawsuit is called a “statute of limitations,” and it varies by state. In some states, you have as little as 1 year to file a lawsuit from the date of your diagnosis. Other states give you up to 6 years.
There is no class action lawsuit for people with sprue-like enteropathy. Each case is very different — some patients were only sick for a few weeks, while others developed permanent intestinal damage or were hospitalized. These lawsuits need to be handled individually.
Our lawyers will review your case for free and let you know if you still have time to file a lawsuit. If you decide to join the MDL, we can help you file a lawsuit and seek compensation for your pain and suffering, medical expenses, lost income, permanent injuries, and more.
Need a Benicar Lawyer in Texas?
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Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Benicar lawyers for a free lawsuit review.