FDA OKs New Packaging for OTC Loperamide to Help Stem Misuse, Abuse

In its ongoing effort to stem misuse and abuse of loperamide (Imodium, Johnson & Johnson), the US Food and Drug Administration (FDA) has approved changes to the packaging for brand-name, over-the-counter (OTC) tablet and capsule formulations of the opioid-based antidiarrheal medication.

The changes to Imodium A-D, Imodium Multi-Symptom Relief, and Be Health Loperamide HCl Capsules limit each carton to no more than 48 mg of loperamide and require the tablets and capsules to be packaged in individual (unit-dose) blister packs, according to an FDA safety communication.

The maximum approved daily dose for adults is 8 mg/day for OTC use and 16 mg/day for prescription use. Abuse and misuse of loperamide is an ongoing problem in the US, the FDA said, with some individuals taking higher-than-recommended doses of loperamide to treat symptoms of opioid withdrawal or to achieve euphoric effects of opioid use.

“The FDA has worked with manufacturers to approve package size limitations and unit-dose packaging for certain over-the-counter loperamide products. These changes are intended to increase the safe use of loperamide products without limiting over-the-counter access for consumers who use these products for their approved uses at the approved dose, according to labeling,” Acting FDA Commissioner Ned Sharpless, MD, said in a statement.

He said the agency is also asking online distributors to 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.”

The FDA is also taking steps to ensure that consumers can easily access and read the product labeling and warnings for drugs sold on shelves or on websites before purchase.

In 2016, the FDA warned about life-threatening cardiac events, including QT interval prolongation, torsades de pointes or other ventricular arrhythmias, syncope, and cardiac arrest, with loperamide misuse and abuse, as reported by Medscape Medical News.

In 2017, the FDA added a warning to the product label about the risk of taking high doses of loperamide. They noted that some individuals are taking higher-than-recommended doses of loperamide to treat symptoms of opioid withdrawal or to achieve euphoric effects of opioid use.

Also in 2017, the FDA added a Heart Alert warning to loperamide “drug facts” labels that warned consumers about the risks of taking higher-than-recommended doses.

The FDA said evidence suggests that package size limits and unit-dose packaging may reduce medication overdose and death.

In 2018, the agency asked manufacturers and packagers of OTC loperamide products to make these changes, as Medscape Medical News reported. Today, the FDA formally notified the public of these approved changes.

https://www.medscape.com/viewarticle/918786