To foster safe use of the over-the-counter anti-diarrhea drug loperamide, FDA is working with manufacturers to use blister packs or other single-dose packaging and to limit the number of doses in a package. FDA continues to receive reports of serious heart problems and deaths with much higher than the recommended doses of loperamide, primarily among people who are intentionally misusing or abusing the product, despite the addition of a warning to the medicine label and a previous communication. Loperamide is a safe drug when used as directed.

Loperamide acts on opioid receptors in the gut to slow the movement in the intestines and decrease the number of bowel movements. It is safe at approved doses, but when much higher-than-recommended doses are taken, it can lead to serious problems, including severe heart rhythm problems and death.

FDA is continuing to evaluate this safety issue and will update the public when more information is available.