Login
Subscribe
July 8, 2013
On July 3, 2013, the Food and Drug Administration (FDA) issued a warning that the blood pressure drug olmesartan (brand names: Benicar, Benicar HCT, Azor, and Tribenzor, as well as generics) can cause a severe intestinal disorder known as sprue-like enteropathy, which causes severe, chronic diarrhea with significant weight loss. The FDA reports that in all 23 reported cases, discontinuing olmesartan resulted in clinical improvement of sprue-like enteropathy symptoms. The agency...
July 8, 2013
On July 3, 2013, the Food and Drug Administration (FDA) issued a warning that the blood pressure drug olmesartan (brand names: Benicar, Benicar HCT, Azor, and Tribenzor, as well as generics) can cause a severe intestinal disorder known as sprue-like enteropathy, which causes severe, chronic diarrhea with significant weight loss. The FDA reports that in all 23 reported cases, discontinuing olmesartan resulted in clinical improvement of sprue-like enteropathy symptoms. The agency has approved revised labels of all olmesartan-containing products to include warnings of this adverse effect.
Olmesartan is an angiotensin II receptor blocker (ARB) approved to treat high blood pressure, either alone or with other antihypertensive agents (though WorstPills.org recommends against using ARBs with ACE inhibitors or aliskiren*). Olmesartan is one of eight marketed ARB drugs and the only member of this drug family currently linked to sprue-like enteropathy.
Read the complete safety alert:
http://www.fda.gov/Drugs/DrugSafety/ucm359477.htm
Patients on olmesartan should ask their doctor about other options to treat high blood pressure. Click here to read the WorstPills.org treatment recommendations for high blood pressure.
Patients should contact their doctor immediately if they develop severe, chronic diarrhea with substantial weight loss while taking an olmesartan-containing product, even if symptoms develop months or years after starting the drug. If no other cause is found for the diarrhea, the drug should be discontinued in favor of therapy with another antihypertensive.
Never stop any medication without first talking with your doctor. Abruptly stopping olmesartan or any other blood pressure medicine can result in fatal complications.
*Note: Patients also should never take olmesartan or other ARB with another class of blood pressure medications, ACE inhibitors, or with the drug aliskiren because the drugs used in combination do not provide any added benefit when compared with any of the drugs given alone and can cause kidney failure, dangerously high blood potassium levels, and low blood pressure. See the e-alert “Do Not Combine ACE Inhibitors, ARBs and Aliskiren” on Worstpills.org for more information.
