Benicar FDA GI Warning
Benicar is one medication in a class known as olmesartan drugs. They are angiotensin receptor blockers (ARBs), and their role is to relax blood vessels. In doing so, they counter the effects of high blood pressure or hypertension.
High blood pressure is a common condition. Also known as the “silent killer,” high blood pressure often goes undiagnosed until it leads to serious health risks. Unchecked hypertension puts a load on the heart and can damage arteries leading to heart and kidney disease and stroke.
Contributing factors to high blood pressure include stress, smoking, drinking too much, obesity, and family history. Lifestyle changes are often recommended in addition to medication.
Approved by the U.S. Food and Drug Administration (FDA) in 2002, the agency has since issued numerous warnings about Benicar use and its links to cardiovascular issues, cancer, pediatric deaths, and gastrointestinal distress, all of which can be very serious or even fatal.
In June 2010, the FDA issued a Safety Announcement that it was evaluating the results of two clinical trials in which Benicar patients with type-2 diabetes had a higher death rate from cardiovascular events than those type-2 diabetic patients in the placebo group.
As if often does, the FDA concluded that the benefits of Benicar in diabetic patients with high blood pressure outweigh its potential risks.
One month later, the agency issued a review of Benicar and other olmesartan drugs including Benicar HCT (olmesartan and hydrochlorothiazide, a diuretic), Azor, Tribenzor, and its link to cancer. The agency found a small increase in the reports of new cancers among patients taking ARBs when compared to those patients not taking ARBs. But once again, the FDA concluded that the numbers were not statistically significant and that the benefits of taking ARBs outweighed their potential risks.
Another “adverse event” as the FDA calls complications, may not be so easy for the FDA to minimize.
By July 3, 2013 the Food and Drug Administration issued a Drug Safety Communication indicating it was changing the label on the olmesartan hypertension drugs, including Benicar, to include diarrhea as an adverse reaction or complication.
The warning says that there is a danger to patients on Benicar of developing gastrointestinal symptoms that include severe, chronic diarrhea with substantial weight loss which could result in hospitalization. The actual condition is known as sprue-like enteropathy, and it may develop years after a patient has been taking olmesartan.
The agency identified 23 serious cases of diarrhea reported to the FDA Adverse Events Reporting System (FAERS). When the FDA looked at the cases, they found patients also had significant weight loss and, in some cases, a biopsy of their intestinal villi showed these organs had stopped working and, in some cases, had atrophied.
In June 2012, the Mayo Clinic found proof positive that Benicar was the culprit.
Researchers there followed 22 patients who were seen at the Mayo Clinic in Rochester, Minnesota between August 1, 2008 and August 1, 2011. They, too, had unexplained chronic diarrhea and an average 40 lb. weight loss. All were taking olmesartan.
Every patient had been put on a gluten-free diet assuming they had Celiac disease, an autoimmune disorder. That is a digestive disorder in which the body has difficulty absorbing nutrients when gluten protein is consumed. In patients with Celiac disease, their immune system forms antibodies in the presence of gluten which attacks the intestinal lining.
Intestines become inflamed and the villi are damaged. Villi are the hair-like structures that line the small intestine designed to absorb nutrients from passing food. If they are damaged, malnutrition can result.
Symptoms of Celiac disease include weight loss, chronic diarrhea, joint pain, bloating, and malnourishment – the same symptoms shared by some patients taking Benicar.
Among the Mayo Clinic group, the gluten-free diet didn’t work, so that diagnosis was ruled out.
Researchers noted something else among this group. The Mayo patients didn’t have the antibodies in the blood typical for Celiac disease. That’s when Mayo Clinic study author Dr. Joseph Murray, a gastroenterologist, and his team turned to Plan B: taking the 22 patients off their olmesartan medications. All 22 patients improved clinically, including weight gain and normal bowel movements. They went on to take a different blood pressure medication.
Follow-up biopsies found an improvement in the intestinal condition had occurred in 18 patients and the villi recovered after discontinuation of olmesartan. However, for some patients, the villi had been permanently damaged and had essentially flattened and atrophied.
Interestingly, German researchers by December 2012 did not observe sprue-like conditions in the 2,200 patients they followed who were taking high-dose olmesartan for more than three years.
It always pays to look at the author’s potential conflicts. Many publications require that be disclosed. In this case, both authors have received compensation for lectures sponsored by Daiichi Sanyko, the maker of Benicar. One author is a medical advisor to the company and has received research grants from the Japanese drug maker. While a conflict-of-interest doesn’t in itself mean science is corrupted, you will rarely find a recipient of research or lecture dollars speaking out against his sponsor.
Considering that fewer than ten percent of adverse events are ever reported to the FDA, according to the General Accounting Office, there are likely ten-times more illnesses that are not recognized and treated. Mayo researchers reported concern that a risk of gastrointestinal problems associated with olmesartan may just be the “tip of the iceberg.”
If there is no other cause of the above gastrointestinal (GI) conditions, the FDA recommends a patient stop taking olmesartan drugs and switch to another blood pressure medication. It is recommended you talk to your doctor before you stop taking olmesartan.
In regard to GI issues, this time the FDA does not say the benefits of taking Benicar outweigh the risks.
There are eight FDA-approved angiotensin II receptor blocker (ARB) drugs. None of the others are linked to gastrointestinal problems.
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