FDA Approves New Loperamide Packaging

Last month the Food and Drug Administration (FDA) announced new package sizes and types for over-the-counter (OTC) loperamide, including Imodium A-D, Imodium Multi-Symptom Relief, and Be Health Loperamide HCl Capsules. The FDA had received reports of serious heart problems and death in people who intentionally misused loperamide by taking high doses of the drug.

Research suggests that some people who have opioid use disorder misuse loperamide to prevent or treat symptoms of withdrawal, and some may take massive doses to get high.

The new requirements limit each carton to no more than 48 mg of loperamide and mandate unit-dose blister packaging. The maximum approved dose of OTC loperamide is 8 milligrams per day. For prescription use, the maximum approved dose is 16 milligrams per day. ■