FDA Aims to Limit Packaging for Anti-Diarrhea Drug to Reduce Abuse, Misuse

To encourage the safe use of the anti-diarrhea medicine loperamide (Imodium), the FDA is working to limit packaging for the medication through use of blister packs and other single-dose packaging, according to an agency safety announcement.¹

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

The medication is safe to take at approved doses but can lead to severe heart rhythm problems and death if taken at much higher doses than recommended.

The FDA continues to receive reports of serious heart problems and deaths occurring with much-higher-than-recommended doses of loperamide, primarily among those who are intentionally abusing or misusing the product, despite the medication’s warning label, according to the announcement.

On June 7, 2016, the FDA issued a drug safety communication to warn individuals about the potentially harmful effects of taking excessive doses of the medication. The majority of reported serious heart problems occurred in individuals who were taking high doses of loperamide to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria, according to the announcement.²

The FDA urged health care providers to be aware of the serious problems associated with the misuse of loperamide, including serious cardiac events, such as cardiac arrest, QT interval prolongation, syncope, and Torsades de Pointes or other ventricular arrhythmias. Additionally, some individuals who are abusing loperamide may be using it in combination with other drugs in attempts to increase its absorption. Health care providers should counsel patients to take loperamide 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.

Reference

• FDA Drug Safety Communication. FDA limits packaging for anti-diarrhea medicine loperamide (Imodium) to encourage safe use. fda.gov/Drugs/DrugSafety/ucm594232.htm. Updated January 30, 2018. Accessed January 30, 2018.
• FDA Drug Safety Communication: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse [safety announcement]. fda.gov/Drugs/DrugSafety/ucm504617.htm. Updated January 30, 2018. Accessed January 30, 2018.