The Japanese drug maker Daiichi Sankyo announced on August 1st that it has agreed to pay up to $300 million to settle some 2,300 U.S. lawsuits filed in US courts.
The widely used blood pressure medication, Benicar (along with its sister drugs, Azor, Tribenzor, Benicar HCT, and Olmesartan/Medoxomil) are charged with causing serious gastrointestinal damage to users. Benicar is an angiotensin II receptor blocker (ARB), FDA-approved to lower blood pressure associated with hypertension, Benicar is a top selling, 2.4 billion dollar a year product for its manufacturer.
The lawsuits assert that the company inadequately warned about the risk of gastrointestinal injury from Benicar and its sister drugs and misrepresented the safety of the products, despite having enough information to know that Benicar, Benicar HCT, Tribenzor and Olmesartan can be unsafe even when used as directed.
The lawsuits contend the medications should have carried warnings on their labels of possible serious gastrointestinal side effects such as sprue-like enteropathy, and that the company had evidence of these complications over a ten-year period. Sprue-like enteropathy is the flattening of the villi (small threads that line the intestine) which are responsible for absorbing nutrition from food being digested. Other conditions Benicar may cause are: lymphocytic colitis, microscopic colitis, and collagenous colitis. Individuals with these conditions can suffer from malnutrition.
Symptoms can include: chronic diarrhea, unexpected and uncontrollable weight loss, nausea,
vomiting, severe abdominal pain, malnutrition, kidney damage/failure, dehydration, malabsorption
villous atrophy/blunting, and osteoporosis. The effects of this drug can be serious enough to result in death.
While Benicar has been marketed since 2002, it was not until 2012 that problems with the drug became public. Researchers at the Mayo Clinic began to suspect a link between Benicar (Olmesartan Medoxomil) and gastrointestinal issues. The clinic had treated twenty-two patients between 2008 and 2011 who were exhibiting symptoms close to those of Celiac disease. The common element was that all the patients had been taking Benicar, and when tested, they were found free of celiac disease. (Celiac disease is a reaction to wheat and gluten that causes the same effects and damage to the intestines that Benicar causes.)
Once they discontinued Benicar, all the patients experienced relief from their symptoms. As a result, Mayo Clinic staff members concluded that the patients’ gastrointestinal issues stemmed from their use of the drug. The researchers did not find any other drug in the ARB class that caused the same symptoms.
Later in the same year, dozens of similar cases were observed both at the Mayo Clinic and other centers, leading researchers to believe that there may be numerous undiagnosed cases among those taking Benicar and its relative drugs.
In 2013, the FDA conducted its own review of twenty-three serious Benicar adverse event reports involving patients with severe diarrhea and weight loss. As with the Mayo Clinic study, all patients in the FDA review reversed symptoms and improved after they stopped taking the drug.
A separate study in 2013, published in the American Journal of Gastroenterology, found damage to intestinal villi (tiny structures that aid digestion) with Olmesartan use.
In July 2013, the FDA mandated a warning label for the product.
It’s very important for patients to know that it can take months or even years for people taking drugs such as Benicar that contain Olmesartan to develop this condition and even longer for it to be properly diagnosed. Persons taking these drugs may have the condition and not be aware of it.
To be eligible to take part in this settlement, an individual must show proof that they were actually taking the drug and that they had an intestinal issue during the time they were taking it. Individuals do not have to prove that the medical condition was the result of the medication nor that they recovered after stopping it. The litigation asserts that in addition to gastrointestinal damage, other medical conditions may have developed as a result of the drug and that those affected by this medicine may also have financial losses, loss of quality of life, emotional pain and suffering and even, in some cases, death.
If you are one of the thousands of people who have taken Benicar, Benicar HCT, Azor, Tribenzor, or Olmesartan Medoxomil, you may be able to participate in this lawsuit. Please contact us immediately.