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FDA Issues Warning for Fatal, Heart-Related Imodium (Loperamide) Side Effects

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Santa Clara, CAThe antidiarrheal medicine Imodium (Loperamide) is the subject of a US Food and Drug Administration (FDA) warning of serious heart problems which can be fatal. The warning applies to both over-the-counter (OTC) and prescription strength medications, which are also sold under other generic names.

The FDA is warning health care professionals to be aware that use of higher than recommended doses of loperamide can result in serious cardiac adverse events. Specifically, it states that physicians should consider loperamide as a possible cause of unexplained cardiac events including QT interval prolongation, Torsades de Pointes or other ventricular arrhythmias, syncope, and cardiac arrest.

According to the FDA statement, the agency has received 48 cases of serious heart problems associated with use of loperamide since it was first approved in 1976. “More than half of the 48 cases were reported after 2010,” the agency notes. Thirty-one of these cases resulted in hospitalizations, and 10 patients died.

"The majority of reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria," the FDA said. "They are also combining loperamide with interacting drugs in attempts to increase these effects."

Loperamide is approved to help control symptoms of diarrhea, including Travelers’ Diarrhea. The maximum approved daily dose for adults is 8 mg per day for OTC use and 16 mg per day for prescription use. It is sold under the OTC brand name Imodium A-D, as store brands, and as generics.

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