FDA Aims to Limit Packaging for Anti-Diarrhea Drug to Reduce Abuse, Misuse – APhA submits compounding comments to FDA. – (866) 348-2889
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.