FDA In Brief: FDA approves new packaging for brand-name over-the-counter loperamide to help curb abuse and misuse

FDA In Brief: FDA approves new packaging for brand-name over-the-counter loperamide to help curb abuse and misuse

Today, the U.S. Food and Drug Administration announced approved package size and package type limits for over-the-counter (OTC) brand-name tablet and capsule forms of loperamide, an FDA-approved drug product that helps control symptoms of diarrhea, including Travelers’ diarrhea. The changes to Imodium A-D, Imodium Multi-Symptom Relief and Be Health Loperamide HCl Capsules are intended to address the problem of loperamide abuse and misuse by limiting each carton to no more than 48 mg of loperamide and requiring unit-dose blister packaging.  The maximum approved daily dose of OTC loperamide for adults is 8 milligrams per day and 16 milligrams per day for prescription use. While loperamide is safe at approved doses, the FDA has received reports of serious heart problems and deaths associated with loperamide, and the majority of ...

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