While acknowledging the safety of the approved daily doses of OTC loperamide for adults (8mg per day) and prescription loperamide (16mg per day), the FDA recently approved new package-size and package-type limits for the brand-name OTC tablet and capsule forms of the drug. Here are the products affected by the FDA’s notice:
- Imodium A-D
- Imodium Multi-Symptom Relief
- Be Health Loperamide HCl Capsules
Loperamide has been referred to as the “poor man’s methadone,” due to effects of abusing the drug via high doses. This has led to reports of “serious heart problems and deaths associated with loperamide,” with “the majority” relating to abuse and misuse of the drug.
The FDA’s action limits the package sizes by “limiting each carton to no more than 48mg” (24 tablets or a 6-day supply at maximum approved use) and provides for unit-dose packaging for the affected products, which the FDA believes “may reduce medication overdose and death.”
The FDA also requested that “online distributors take voluntary steps to help reduce the risks of loperamide abuse and misuse by not selling more than one package of these drugs to each customer.”
Finally, the FDA announced that it “is also taking steps to make sure that consumers can easily access and read the product labeling and warnings for drugs sold on shelves or on websites before purchase.” These efforts relate to generic manufacturers and liquid loperamide products as well. This is a continuation of a 2018 FDA request.