Benicar, also known by its trade name Olmesartan, was developed in 1995 by Japanese pharmaceutical company Sankyo. It is an effective treatment of high blood pressure, though it operates in the body differently than the more popular ACE inhibitors. Instead, it blocks the binding of hormones that cause blood vessels to constrict. It’s a slight difference in function, but the result is the same – the vessels are kept open and flowing. Since its development, there have been several other branded drugs that operate like Olmesartan, including Tribenzor or Azor.
Sankyo spent nearly $1 billion marketing its drug to doctors and hospitals around the world. It engaged in its heaviest marketing from 2002 to 2008, and during this time, Sankyo claimed that Benicar was a safer, more effective way to treat high blood pressure. And while the drug is considered safer than a lot of other blood pressure medications, it can still cause severe complications in some people.
Complications That Can Cause Agony
For years, most research verified Sankyo’s claims that Olmesartan was safe. In fact, it was once believed to be no more dangerous than a placebo, which would have been quite the feat given its pharmacological profile. However, in the medical world, claims like these are usually too good to be true. And so it is with Olmesartan.
From 2008 to 2011, the Mayo Clinic began seeing a slow trickle of patients complaining of severe, chronic diarrhea and “sprue-like enteropathy,” which refers to an intestinal disease that causes malnourishment and weight loss. The Mayo Clinic recorded its findings with 22 patients who exhibited the symptoms during the three years of observation, and in every case ruled out celiac disease as the cause.
The common factor in all 22 patients was the administration of Benicar. In 14 of the 22 patients, weight loss was dramatic enough to require hospitalization, and in 15 of the patients, profound villous atrophy was found during intestinal biopsies. Villous atrophy is a dangerous condition in which the intestines shed their lining and lose their texture, also losing their ability to absorb nutrients in the process. The symptom profile is similar to celiac disease, but the degree of weight loss and malnutrition are much greater.
The Mayo Clinic followed up with 18 of the 22 patients who suffered sprue-like enteropathy, and found that after removing Olmesartan from their regimen, all of the patients improved. Although the Mayo Clinic believes more research is needed, the FDA has acknowledged that there is likely a link between Benicar and some intestinal diseases. Unfortunately, as digestive issues are often explained by many factors, it’s likely that some victims of Olmesartan don’t know that their pains are due to the drug. Many patients, for instance, are first admitted to the hospital for dehydration or abdominal pain, both of which are ubiquitous enough to be blamed on a variety of conditions.
That’s little comfort to George Williams, who, in February 2014, filed a lawsuit against Sankyo due to severe intestinal complications he suffered as a result of taking Olmesartan. According to Williams, the sprue-like enteropathy and chronic diarrhea he experienced was so severe that he had to be hospitalized for more than 100 days. The malnutrition he suffered, along with the treatment required to reverse his symptoms, resulted in a compression fracture in his spine and cataracts. He can no longer process food normally and must rely on a feeding tube to provide him his nutrition for the rest of his life. Williams will likely face extensive medical expenses, along with a major loss of life quality, for the rest of his days.
Worryingly, there is no current way for doctors to predict who will have a reaction to Benicar. This is the kind of research, of course, that patients hope pharmaceutical companies perform before releasing their products to the market. If, after all, there is $1 billion available for advertising purposes, why couldn’t more of that money have been dedicated to additional safety research? This is the question that more and more victims of Olmesartan are asking, and they are taking action against Sankyo in the process.