Benicar® Blood Pressure Medication May Cause Serious Intestinal Problems
On July 3, 2013, the FDA issued a drug safety communication for all medications containing the active ingredient, olmesartan medoxomil. Benicar® belongs to a class of medications known as angiotension II receptor blockers (ARBs), approved to treat high blood pressure. Although the blood pressure drug is best known under the brand name, Benicar®, it is also sold as Azor®, Tribenzor®, and in generic form.
According to the drug safety communication, there is “clear evidence” of an association between olmesartan and sprue-like enteropathy, including severe, chronic diarrhea and significant weight loss. These complications can be serious enough to require hospitalization, and may begin months or even years after beginning the treatment regimen.
Prior to issuing the communication, the FDA had received at least 23 serious cases of diarrhea and substantial weight loss linked to Benicar® or comparable drugs. In all cases, the patients improved after they stopped taking the drug. In conjunction with its drug safety communication, the FDA has approved label changes for all olmesartan medoxomil drugs, which incorporate a warning about the increased risk of intestinal problems. According to the FDA, approximately 10.6 million prescriptions of Benicar® and similar drugs were dispensed in 2012.
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