Individuals who took Benicar or other olmesartan-containing drugs and developed sprue-like enteropathy are filing lawsuits against the drug’s maker, Daiichi Sankyo. These lawsuits began piling up against the pharmaceutical company soon after the FDA made its safety announcement in 2013. Three years later, more than 1,200 lawsuits are pending in federal court against the drug maker. The lawsuits were consolidated into a multi-district litigation (MDL) in the U.S. District Court for the District of New Jersey. There may be substantial cash settlements from claims made today.
If you took Benicar, Benicar HTC, Azor or Tribenzor and developed sprue-like enteropathy or villous atrophy, you may be entitled to compensation. Contact our Benicar lawyers today for a free case evaluation by calling 1-800-214-1010 or use the form on the right-hand side of the screen.
What is Benicar?
Benicar is a popular prescription medication used to treat high blood pressure in adults and children aged six to 16.
About 1 in 3 American adults have high blood pressure, a condition called hypertension, and another one-third of adults have pre-hypertension. High blood pressure costs the nation roughly $46 billion each year in health care services, medications and missed days of work, according to the Centers for Disease Control. It can also lead to a heart attack, stroke, heart failure and kidney failure if left untreated.
The Food and Drug Administration (FDA) approved Benicar on April 25, 2002, making it the seventh drug of its kind on the market. After its approval, Benicar became one of the top-selling drugs in its class in the U.S.
Manufactured by Japanese pharmaceutical giant Daiichi Sankyo, Benicar brought in well over a billion dollars each year between 2009 and 2011. Sales of Benicar have been dropping steadily since 2012, thanks in part to competition from generic versions of similar drugs. The most recent sales data from Daiichi Sankyo’s annual reports show Benicar’s North American sales at $700 million in 2014, down more than 37 percent from 2011.
How does Benicar work?
Benicar’s main ingredient, olmesartan, belongs to a class of drugs called angiotensin receptor blockers, or ARBs.
ARBs lower blood pressure by blocking the activation of angiotensin II AT1 receptors in the body. Blocking these receptors causes blood vessels to widen, which causes blood to flow through more easily and reduces blood pressure.
Blocking the AT1 receptors also reduces the amount of vasopressin and aldosterone released in the body. Vasopressin is an antidiuretic hormone that retains water in the body and constricts blood vessels; aldosterone is a steroid hormone that plays a key role in regulating blood pressure.
Gastrointestinal Side Effects
Since its approval, Benicar has also been plagued by ongoing safety reviews from the FDA. Roughly three years ago, the FDA announced it was reviewing the safety of Benicar after studies showed a link between the hypertension drug and a gastrointestinal problem known as sprue-like enteropathy. The agency required Daiichi Sankyo to include this warning on the drug’s label.
Sprue-like enteropathy is marked by severe, chronic diarrhea that causes substantial weight loss in affected patients. The symptoms of sprue-like enteropathy mimic those of Celiac disease, causing some patients to be misdiagnosed. Celiac disease is a hypersensitivity to gluten, which causes inflammation and damage to the small intestine. Patients with Celiac disease benefit from a gluten-free diet. Patients with sprue-like enteropathy caused by Benicar, on the other hand, do not benefit from a gluten-free diet; instead, their symptoms subside only when they stop taking Benicar.
Sprue-like enteropathy: What is it?
Sprue-like enteropathy is a condition that affects the small intestine and is usually associated with Celiac disease. The condition causes damage to the small intestine, resulting in severe, chronic diarrhea and weight loss.
Sprue-like enteropathy can occur several months to several years after a person starts taking Benicar. In some cases, it is severe enough to require hospitalization. Symptoms typically subside about a week after a person stops taking the drug.
Sprue-like enteropathy can also lead to another condition called villous atrophy, which causes the finger-like projections in the small intestine to erode away. These projections, called the villi, are responsible for absorbing nutrients from food to be used by the body.
Symptoms of Sprue-like enteropathy
The most common symptoms of sprue-like enteropathy are chronic diarrhea with weight loss. But patients with sprue-like enteropathy can also suffer from the following symptoms:
- Nausea and vomiting
- Abdominal pain
Severe symptoms lead to hospitalizations
In some cases, patients suffering from sprue-like enteropathy had symptoms severe enough to require hospitalization, even stays in the intensive care unit.
Severe symptoms that required hospitalization included severe dehydration, electrolyte imbalance, acute renal failure and the need for parenteral nutrition (feeding a person intravenously).
Mayo Clinic alerts FDA to Benicar GI problems
The Mayo Clinic notified the FDA in 2012 after its researchers discovered a link between the hypertension medication Benicar and sprue-like enteropathy.
Between 2008 and 2011, the Mayo Clinic saw 22 patients at its Rochester, Minn. hospital who suffered from unexplained chronic diarrhea and weight loss.
Doctors ruled out celiac disease in all 22 patients, but noticed all of the patients were taking olmesartan-containing drugs, like Benicar. The patients were ordered to stop taking the drugs, and all 22 got better.
Researchers concluded olmesartan caused the patients’ gastrointestinal problems and notified the FDA of its findings. Subsequently, the FDA launched an investigation into the claims and, in 2013, required Daiichi Sankyo to include the risk of sprue-like enteropathy on the Benicar label.
How does Benicar cause sprue-like enteropathy?
It is unclear exactly how Benicar can cause sprue-like enteropathy in some patients. Researchers suggest that because it usually takes a while for the symptoms of sprue-like enteropathy to appear, the condition could be caused by a delayed hypersensitivity to the drug.
The inhibitory effects of Benicar on a certain protein in the body called the transforming growth factor beta (TGF-beta) may also cause sprue-like enteropathy, since TGF-beta is an important mediator of gut homeostasis.
The first study to report on the effects of Benicar on sprue-like enteropathy by Rubio-Tapia et al. also suggested the presence of HLA-DQ2 in the body may predispose a person to sprue-like enteropathy while taking Benicar. HLA-DQ2 is one of the major risk factors for celiac disease.
Benicar is only ARB to cause sprue-like enteropathy
The FDA analyzed data to see whether or not other ARB drugs could cause sprue-like enteropathy in some patients. According to the agency, people taking olmesartan had a higher rate of celiac disease diagnoses than people taking other ARBs. The agency concluded the increased risk of sprue-like enteropathy was most likely not a class effect – meaning it was specific to olmesartan containing drugs and not all ARBs.
Other ARBs currently on the market include:
Olmesartan is the main ingredient in Benicar and can also be found in combination drugs, including Benicar HCT, Tribenzor and Azor.
Benicar lawsuit claims and settlements page updated on June 8, 2016.