Olmesartan Label to Include Intestinal Problems, FDA Says

July 03, 2013

BETHESDA, Maryland— The US Food and Drug Administration has approved a label change for the angiotensin-receptor blocker (ARB) olmesartan (Benicar, Daiichi Sankyo) to state that the drug can cause an intestinal problem known as spruelike enteropathy[1]].

The symptoms of spruelike enteropathy include severe and chronic diarrhea that results in significant weight loss. Olmesartan is the only ARB known to cause this adverse event. The agency is continuing to monitor the safety of all olmesartan-containing products.

The label change is based on an evaluation of adverse events received by the FDA's Adverse Event Reporting System (FAERS), a published literature case series, and other data. In the FAERS, the agency identified 23 patients who presented with late-onset diarrhea and significant weight loss. All patients improved clinically when olmesartan was stopped. When 10 patients were rechallenged with the drug, the symptoms appeared again.

"Healthcare professionals should tell patients to contact them if they develop severe, chronic diarrhea with substantial weight loss while taking an olmesartan-containing product, even if it takes months to years for symptoms to develop," according to the FDA MedWatch safety alert. "Patients should contact their healthcare professional right away if they take an olmesartan-containing product and experience severe diarrhea, diarrhea that does not go away, or significant weight loss."

Physicians treating patients with these symptoms should first rule out other etiologies, including celiac disease. If no other cause is identified, "olmesartan should be discontinued and another antihypertensive treatment started," according to MedWatch.

In June 2012, Dr Joseph Murray (Mayo Clinic, Rochester, MN) and colleagues published a report in the Mayo Clinic Proceedings stating that 22 patients taking olmesartan were seen in their clinic for unexplained diarrhea and enteropathy.

As reported by heartwire at the time, celiac disease was ruled out, and the patients failed to improve on a gluten-free diet. The patients lost a median of 18 kg but showed signs of clinical improvement once they stopped taking olmesartan. After stopping the ARB, they regained an average of 12.2 kg, and intestinal inflammation subsided in 18 of the 22 patients.

The Mayo Clinic findings constituted part of the FDA's review of olmesartan.


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