Industry Briefs

Taking High Doses of Imodium Increases Risk of Adverse Cardiovascular Events, FDA Warns

Earlier this month, the Food and Drug Administration (FDA) issued a warning that patients who take higher than recommended doses of the common over-the-counter and prescription antidiarrheal medicine loperamide (Imodium) may experience serious heart problems, including abnormal heart rhythms and cardiac arrest.

A review of the FDA Adverse Event Reporting System database from December 28, 1976 (initial FDA approval) through December 14, 2015 revealed 48 cases of serious cardiac events with loperamide use. The most frequently reported cardiac events were syncope (n=24), cardiac arrest (n=13), QT interval prolongation (n=13), ventricular tachycardia (n=10), and Torsades de Pointes (n=7). According to the database, 22 of the 48 cases involved abusing high doses of loperamide, a μ-opioid agonist, and 17 cases involved taking loperamide to treat diarrhea.

According to the FDA, “Data from U.S. poison control call centers indicate that since 2006, and particularly since 2010, calls have increased for intentional loperamide exposures, which include cases of intentional abuse, intentional misuse, suspected suicide attempt, and unknown intentional exposures.” ■