Benicar Sprue-Like Enteropathy, Chronic Diarrhea
The hypertension drug Benicar has been associated with a risk of sprue-like enteropathy, which can cause chronic diarrhea and other symptoms similar to celiac disease.
These side effects of Benicar may develop months or even years after use the popular blood pressure drug begins, often leaving individuals with severe and debilitating health complications, including:
- Chronic Diarrhea
- Unhealthy Weight Loss
- Vomitting and Nausea
- Dehydration and Malnutrition
- Immune System Problems
Benicar Enteropathy Problems
Benicar (olmesartan medoxomil) is part of a family of blood pressure drugs sold by Daiichi Sankyo that contain olmesartan medoxomil, including Benicar HTC, Azor and Tribenzor. All of these medications carry a risk of Benicar sprue-like enteropathy.
Known as an ARB, or angiotensin II receptor blockers, Benicar works by preventing angiotensin II from binding to receptors on blood vessels. This causes the blood vessels to dilate or enlarge, reducing blood pressure and making it easier for the heart to pump blood.
With an estimated 10.6 million prescriptions dispensed each year, Benicar is the third best-selling ARB on the market. However, it is the only ARB blood pressure drug that has been linked to enteropathy side effects, according to the FDA.
In August 2012, a study (PDF) was published in the medical journal Mayo Clinic Proceedings, outlining 22 cases of Benicar patients with celiac disease symptoms, including chronic diarrhea, vomiting, nausea, weight loss, abdominal pain and fatigue.
Although celiac disease is typically only seen among individuals with a genetic predisposition, and there is no known cure, researchers discovered that Benicar patients showed signs of improvement when the medication was no longer used.
This study provided information to the medical community for the first time that suggested that potential Benicar side effects may include diarrhea and other symptoms of sprue-like enteropathy.
In July 2013, the FDA issued a warning about the link between side effects of Benicar and sprue-like enteropathy (PDF). The federal health regulators indicated that there is “clear evidence” of an association between Benicar and diarrhea, weight loss and other related symptoms.
Reports suggested a strong association, as the problems on Benicar stopped when the medications were discontinued and often resumed when the drug was started again.
The FDA warned that Benicar enteropathy problems may develop months or even years after treatment begins, often resulting in repeated hospitalization. If symptoms develop and no other causes are found, the agency informed doctors that Benicar should be discontinued.
As a result of the failure to warn about these potential risks, many users of the drug have been misdiagnosed with celiac disease or unclassified sprue on Benicar.
The FDA noted that the rate of celiac disease with Benicar was higher than is associated with other ARB blood pressure medications. In addition, after the discovery of the link between Benicar and enteropathy, the rates of unclassified sprue diagnosed dropped 30%.
Long-Term Benicar Risks
Sprue causes autoimmune problems in the small intestines that can result in numerous gastrointestinal problems. These can include severe, chronic diarrhea, substantial weight loss, nausea and vomiting, and electrolyte abnormalities.
While symptoms may resolve when the medication is no longer used, individuals can be left with long-term health complications from Benicar known as villous atrophy, which occurs when the microscopic tentacles that line the wall of the small intestine erode.
Villous atrophy interferes with the absorption of nutrients, can reduce digestive capabilities and can lead to malnourishment and dehydration caused by damage due to the presence of gluten. This may lead to a misdiagnosis of celiac disease, and a recommendation that the patient avoid eating products containing gluten, which does not address the actual problem.
Diagnosis of Benicar-induced villous atrophy may involve an endoscopy with biopsy to determine the extent of damage to the villi and small intestines. The extent of damage is often rated by a Marsh Score:
- Villous Atrophy Marsh Stage 3: Indicates a parital to total villous atrophy, which can limit the ability of the small intestines to absorbe nutrients from food and cause malnourishment and dehydration.
- Villous Atrophy Marsh Stage 4: Indicates a total villous atrophy plus damage to the intestinal crypts, which is the intestinal lining that surround the villi. This carries a severe risk that undigested food particles may pass into the bloodstream, where they can set off an immune reaction and numerous food sensitivities.
In many cases, individuals have been repeatedly hospitalized over a period of several years as a result of Benicar diarrhea problems, which may leave them with severe small intestine damage that now requires the use of feeding tube.
Benicar Failure to Warn Lawsuits
Since introducing Benicar, Daiichi Sankyo has engaged in aggressive advertising to promote use of the hypertension drug, spending an estimated $1 billion on promotions between 2002 and 2008. The Benicar advertisements have indicated that the drug is a superior ARB, with increased efficacy and safety.
Twice the FDA has issued warning letters citing the drug company for making false and misleading statements about Benicar safety, indicating that some of the company’s claims about the drugs benefits were unsubstantiated and finding that Daiichi Sankyo failed to include important Benicar risk information in some advertisements.
Serious concerns have been raised about the drug maker’s failure to properly research the potential Benicar side effects before introducing the drug and apparent decision to place their desire for profits before consumer safety by withholding important information about the risk of sprue-like enteropathy once information became available from post-marketing adverse event reports.
Daiichi Sankyo knew or should have discovered the link between Benicar and diarrhea problems. The increased rate of symptoms consistent with celiac disease was seen among independent reviews of adverse event data.
Although it was known that physicians commonly prescribe hypertension drugs for 6 months to a year or longer, Benicar clinical trials lasted only up to three months in duration. In many cases, symptoms of problems from Benicar do not appear for many months after use of the drug begins, so longer clinical trials could have and should have discovered these Benicar effects earlier.
The injury lawyers at Saiontz & Kirk, P.A. are no longer accepting new cases following recent Benicar settlements reached as a result of the drug makers’ failure to warn.