Benicar and Gastrointestinal Disease

Hypertension (high blood pressure) is a very common cardiovascular condition, and while the condition can sometimes be treated with proper diet and exercise, medication can be necessary for some people.  One medication that has been prescribed to treat hypertension is Benicar (olmesartan).  Like other medications, Benicar has been linked with several side effects, but some are more severe than others.  One such side effect linked to Benicar is an intestinal ailment known as spruelike enteropathy.  The symptoms of enteropathy include severe chronic diarrhea with substantial weight loss.  At times, this can present serious health risks.

In 2013, the FDA required Benicar warning labels be updated to include information on the link between Benicar and gastrointestinal disease.

Studies Show: Benicar Linked to Severe Gastrointestinal Disease

2012 – An article in Mayo Clinic Proceedings titled “Severe spruelike enteropathy associated with olmesartan” aimed to “report the response to discontinuation of olmesartan, an angiotensin II receptor antagonist commonly prescribed for treatment of hypertension, in patients with unexplained severe spruelike enteropathy.”

Studying 22 patients seen at the Mayo Clinic in Rochester, Minnesota who suffered from unexplained chronic diarrhea and enteropathy while taking olmesartan, the team found that 14 of the 22 patients had to be hospitalized as a result of weight loss due to diarrhea.  Fifteen patients experienced villous atrophy and various degrees of mucosal inflammation, and 7 showed signs of subepithelial collagen deposition.  Collagenous or lymphocytic gastritis was documented in 7 patients, and microscopic colitis was documented in 5 patients.

All of the patients showed clinical improvement after suspension of olmesartan.  

2013 – A study published in Case Reports in Gastrointestinal Medicine titled “Spruelike enteropathy associated with olmesartan: an unusual case of severe diarrhea.” again illuminated the connection between Benicar (olmesartan) and spruelike enteropathy.

In their paper, the team describes the case of a “64-year-old male with a history of hypertension [who] presented with worsening diarrhea and 25-pound weight loss over the preceding three months.” (emphasis added)

Thankfully, after two months and stopping Benicar, the man “achieved a complete resolution of diarrhea and regained 20-pound weight.”

However, the team concluded that “Spruelike enteropathy is a clinical entity manifested by chronic diarrhea and intestinal villous atrophy. Spruelike enteropathy associated with olmesartan as a cause of drug-induced diarrhea is rare, and it has been reported only in a case series to date. This case highlighted the importance for clinicians to maintain a high index of suspicion for olmesartan as a precipitant of spruelike enteropathy.” (emphasis added).

2014 – An article titled “Five cases of sprue-like enteropathy in patients treated by olmesartan,” shows again that exposure to Benicar is linked to an increased risk for severe gastrointestinal disease.

Here is an excerpt from the abstract of that article:

“We describe five cases of sprue-like enteropathy during treatment with olmesartan, [a drug] indicated for the treatment of hypertension. Patients presented severe diarrhoea, significant weight loss or dehydration, with or without intestinal villous atrophy. Clinical signs ceased upon drug discontinuation in all cases; olmesartan was reintroduced in two cases and rechallenge was positive in both. These add to the previously reported cases that led to a label change for olmesartan in the United States. However, all cases were observed in a small gastroenterology unit, which suggests that this adverse effect may not be rare.” (emphasis added)

Benicar News

Benicar and Gastrointestinal Disease

August 18th, 2014

In January, 2013, an article by Stephanie E. Dreifuss and a team from University of Pittsburgh published an article in Case Reports in Gastrointestonal Medicine titled “Spruelike enteropathy associated with olmesartan: an unusual case of severe diarrhea.”.  There, the connection between the high blood pressure drug Benicar (olmesartan) and sprue like enteropathy was again made clear.In their paper, the team describes the case of a “64-year-old male with a history of hypertension [who] presented with worsening diarrhea and 25-pound weight loss over the preceding three months.” (emphasis added)Dreifuss et al. continue: “Prior screening colonoscopy was unremarkable, and the patient failed conservative management. On presentation, the patient had orthostatic hypotension associated with prerenal azotemia for which olmesartan (40mg/day) was held.”At first, the “Initial workup for chronic diarrhea was essentially unremarkable. Then, EGD was performed with small bowel biopsy, which showed a moderate villous blunting and an intraepithelial lymphocyte infiltration.”Thankfully, after two months, the man “achieved a complete resolution of diarrhea and regained 20-pound weight.”However, the team concluded that “Spruelike enteropathy is a clinical entity manifested by chronic diarrhea and intestinal villous atrophy. Spruelike enteropathy associated with olmesartan as a cause of drug-induced diarrhea is rare, and it has been reported only in a case series to date. This case highlighted the importance for clinicians to maintain a high index of suspicion for olmesartan as a precipitant of spruelike enteropathy.” (emphasis added)Due to the fact that the manufacturers of Benicar (olmesartan) have failed time and again to adequately warn users of this risk, the FDA required the warning labels be updated in 2013 and a great number of Benicar lawsuits have been filed.

Benicar (olmesartan) Associated with Spruelike Enteropathy

October 2nd, 2013

Hypertension is a very common cardiovascular condition, also known as high blood pressure.  While the condition can at times be treated with proper diet and exercise, sometimes it is necessary for medications to be prescribed.  One medication that has been prescribed to treat hypertension is olmesartan (Benicar).  Like many other medications, olmesartan (Benicar) has been linked with several side effects, such as intestinal issues known as sprue-like enteropathy.  The symptoms of enteropathy include severe chronic diarrhea with substantial weight loss.

One study conducted to investigate the link between olmesartan and sprue-like enteropathy was conducted by A Rubio-Tapia et al. within the Division of Gastroenterology and Hepatology of the Mayo Clinic in Rochester Minnesota.  The study is titled “Severe spruelike enteropathy associated with olmesartan” and was published in Mayo Clinic Proceedings in 2012.  The objective of the study was “To report the response to discontinuation of olmesartan, an angiotensin II receptor antagonist commonly prescribed for treatment of hypertension, in patients with unexplained severe spruelike enteropathy.”

The report included 22 patients seen at the Mayo Clinic in Rochester, Minnesota.  These patients were suffering from unexplained chronic diarrhea and enteropathy while taking olmesartan (Celiac disease was ruled out as the cause of the symptoms).  14 of the 22 patients were hospitalized as a result of weight loss due to diarrhea.  15 patients experienced villous atrophy and various degrees of mucosal inflammation, while 7 showed signs of subepithelial collagen deposition.  Collagenous or lymphocytic gastritis was documented in 7 patients, and microscopic colitis was documented in 5 patients.

A gluten-free diet did not alleviate the symptoms, instead all of the patients showed clinical improvement after suspension of olmesartan.  The authors of the report concluded that “Olmesartan may be associated with a severe form of spruelike enteropathy. Clinical response and histologic recovery are expected after suspension of the drug.”

2014 – Benicar linked to severe gastrointestinal side effects

August 27th, 2014

In May 2014, Hélène Théophile and a team of researchers published an article titled “Five cases of sprue-like enteropathy in patients treated by olmesartan,” which further demonstrated that exposure to Benicar (olmesartan) is linked to an increased risk for severe gastrointestinal disease.

Here is the abstract for that article:

“We describe five cases of sprue-like enteropathy during treatment with olmesartan, [a drug] indicated for the treatment of hypertension. Patients presented severe diarrhoea, significant weight loss or dehydration, with or without intestinal villous atrophy. Clinical signs ceased upon drug discontinuation in all cases; olmesartan was reintroduced in two cases and rechallenge was positive in both. These add to the previously reported cases that led to a label change for olmesartan in the United States. However, all cases were observed in a small gastroenterology unit, which suggests that this adverse effect may not be rare. A preliminary search for the other angiotensin II receptor antagonists in the French pharmacovigilance system found severe diarrhoea and colitis, but no case with villous atrophy. Therefore, in the presence of severe diarrhoea, olmesartan or other angiotensin II receptor antagonists should be discontinued, even if the treatment has been taken for several months or years.” (emphasis added)

2013 – Study Shows: Benicar Associated with Severe Gastrointestinal Disease

October 5th, 2013

Villous atrophy is a condition of the intestines, which leads to poor nutrient absorption.  This condition is typically associated with celiac disease.  However, cases of villous atrophy have been reported, in which Celiac disease was not present.  These patients are characterized as having unclassified sprue (US), and such cases are problematic — optimal management of US is unknown.One study that was conducted to identify the cause of US was performed by M DeGaetani et al. within the Celiac Disease Center of Columbia University College of Physicians and Surgeons in New York.  The study is titled “Villous atrophy and negative celiac serology: a diagnostic and therapeutic dilemma” and was published in American Journal of Gastroenterology in earlier this year.The study included 72 adult patients suffering from villous atrophy with negative celiac disease tests.  The researchers conducted several tests to determine the cause of the villous atrophy.  The study included “Testing for HLA DQ2/8 alleles, antienterocyte antibodies, giardia stool antigen, bacterial overgrowth, total serum immunoglobulins, and HIV”The results showed that after conducting all these tests, the most common diagnoses showed medication-related villous atrophy and unclassified sprue.  For those diagnosed with US, symptomatic improvement was generally seen with immunosuppressive therapy.  Additionally, the authors stated that “Some patients initially labeled as unclassified were found to have VA associated with olmesartan [(BENICAR)] use.”Ultimately, these researchers came to the conclusion that “The role of medications in the development of VA and the optimal dose and length of immunosuppression for patients with US should be investigated further.