Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin, Advanced Practice Nurse.
On January 30, 2018, to foster safe use of the over-the counter (or OTC) anti-diarrhea drug loperamide, FDA announced it is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package. We continue 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 is FDA-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. Loperamide acts on opioid receptors in the gut to slow movement in the intestines and decrease the number of bowel movements.
Health care professionals should be aware that using much higher than recommended doses of loperamide can result in serious cardiac adverse events, including QT interval prolongation, Torsades de Pointes or other ventricular arrhythmias, syncope, and cardiac arrest. In cases of abuse, individuals often use other drugs together with loperamide in attempts to increase its absorption and penetration across the blood-brain barrier, inhibit loperamide metabolism, and enhance its euphoric effects. Some individuals are taking high doses of loperamide to treat symptoms of opioid withdrawal. If loperamide toxicity is suspected, promptly discontinue the drug and start necessary therapy. Counsel patients to take loperamide only as prescribed, or according to the OTC Drug Facts label, and advise patients that drug interactions with commonly used medicines may increase the risk of serious cardiac events.
We previously issued a Drug Safety Communication about this safety concern and added warnings about serious heart problems to the drug label of prescription loperamide and to the Drug Facts label of OTC loperamide products. We are continuing to evaluate this safety issue and will update the public when more information is available.
Report side effects involving loperamide to FDA’s MedWatch program at www.fda.gov/medwatch.
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