FDA Approves New Packaging for Brand-Name Over-the-Counter Loperamide

Officials from the FDA have announced an approved package size and package type limit for over-the-counter (OTC) brand-name tablet and capsule forms of loperamide.

Loperamide, an FDA-approved drug product, helps control the symptoms of diarrhea, including travelers’ diarrhea. The changes, specifically to Imodium A-D (Johnson & Johnson), Imodium Multi-Symptom Relief (Johnson & Johnson), and Be Health Loperamide HCl Capsules (Bionpharma), are intended to address the problem of loperamide abuse and misuse. This will limit each carton to no more than 48 mg of loperamide and require unit-dose blister packaging.

The FDA has received reports of serious heart problems and deaths associated with loperamide, even when adults have taken the OTC and prescription maximum approved daily doses. The majority of the adults who reported serious heart problems occurred in individuals who were intentionally misusing and abusing higher doses of loperamide, according to the agency.

In spring 2017, a Heart Alert warning was added to loperamide Drug Facts labels in attempt to warn consumers that taking more than directed can cause serious heart problems or death. Previous evidence suggests that package size limitations and use of unit-dose packaging may reduce medication overdose and death.

Following this, the FDA requested that manufacturers and packagers of OTC loperamide products change the way they label and package loperamide in 2018.

The FDA continues to review this important safety issue and to work with manufacturers, including manufacturers of generic and liquid loperamide products, to make appropriate packaging changes to support the safe use of those products.

Reference

FDA approves new packaging for brand-name over-the-counter loperamide to help curb abuse and misuse [news release]. Silver Spring, MD; September 20, 2019: FDA website. https://www.fda.gov/news-events/fda-brief/fda-brief-fda-approves-new-packaging-brand-name-over-counter-loperamide-help-curb-abuse-and-misuse?utm_campaign=092019_FIB_FDA%20approves%20new%20packaging%20for%20brand-name%20loperamide&utm_medium=email&utm_source=Eloqua. Accessed September 20, 2019.