Benicar Users Are at Risk of Serious Intestinal Side Effects

About 10.6 million prescriptions of Benicar and similar drugs to treat high blood pressure were dispensed last year. Earlier this month, the FDA issued a warning about Benicar, Azor, Tribenzor and their generic versions concerning intestinal side effects that can be severe enough to send patients to the hospital.

The active ingredient in the drug, olmesartan medoxomil, can cause what physicians call spruelike enteropathy-severe, chronic diarrhea and significant weight loss. The problem can manifest months or even years after a patient begins the treatment regimen.

The FDA identified the risk after analyzing adverse event reports submitted by doctors and patients, and by researching published case studies. As reported on, FAERS, the FDA’s adverse event reporting system, received at least 23 serious cases of diarrhea and significant weight loss involving Benicar or similar drugs. All of those patients improved after they stopped using the drugs.

At the FDA’s direction, the labels for all drugs containing olmersartan medoxomil will be changed to add information about the risk of intestinal side effects.

It’s an appropriate response, but also, it seems, a tardy one: Last year, according to AboutLawsuits, a Mayo Clinic study found 22 cases in which its physicians had treated patients with symptoms similar to celiac disease. All of the patients were taking Benicar.

Celiac disease is an autoimmune disorder that has no cure but can be treated by not eating gluten, a protein in wheat and some other grains. Usually, celiac disease strikes people with a genetic predisposition toward it, but the Mayo Clinic patients taking Benicar got relief from their intestinal problems when they stopped taking it.

And three years ago, the FDA began investigating Benicar for a possible association with increased risk of cardiac death among type 2 diabetes patients because 25 patients involved in two different studies died from cardiovascular problems while they were taking Benicar.

Benicar belongs to a class of drugs called angiotensin II receptor blockers (ARBs) that is approved for the treatment of high blood pressure. Intestinal side effects have not been noted in other ARBs, only those with olmersartan medoxomil.

If you have diabetes, discuss with your doctor the wisdom of taking Benicar or a similar drug. If you have a problem with one of them, file a report at MedWatch, the FAERS portal for reporting adverse events associated with drugs and medical devices.

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