Will New Packaging for OTC Loperamide Curb Abuse?

The FDA has approved packaging changes for the brand-name and generic over-the-counter (OTC) tablet and capsule formulations of loperamide (Imodium, Johnson & Johnson). Loperamide is indicated for use as an antidiarrheal but is often abused.  Loperamide acts on opioid receptors, and at higher doses, it can help treat symptoms of opioid withdrawal or can cause the euphoric effects of opioid use. Loperamide is available in 2 mg tablets and capsules. The maximum approved daily dose for adults is 8 mg/day as an OTC product and 16 mg/day for prescription use. When loperamide is abused, it heightens the risk for cardiac events such as QT interval prolongation, arrhythmias, syncope and cardiac arrest. 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 (24 tablets or capsules) and requires unit-dose packaging of the tablets and capsules in blister packs.

The FDA worked with manufacturers to authorize package size limitations and unit-dose packaging for OTC loperamide products. The changes were implemented in hopes of deterring customers who inappropriately use this medication. The FDA believes there is evidence to support the alteration in package size and the unit-dose packing to decrease the number of medication related overdoses and deaths. Pharmacies are still able to sell this medication as an OTC, therefore, the average consumer who takes this medication as an antidiarrheal will not face any obstacles due to the changes.

Through 2015, the FDA received reports of 48 cases of serious heart problems associated with use of loperamide. Additionally, data from U.S. poison control call centers indicate that calls have increased for intentional loperamide exposures at a faster rate since 2010. With this change in packaging, pharmacists and pharmacy technicians need to have an increased awareness of large volume purchases or a sudden spike in sales of this product to identify potential loperamide abuse.  While limiting package sizes by the FDA is a reasonable first step, patient safety concerns may warrant the need for states to regulate individual sales. If this trend continues, retail pharmacies will need to consider updating their POS systems to require counseling on OTC loperamide sales.  In addition, retailers will need to implement system enhancements if OTC loperamide transactions require a monitoring process like the process used for pseudoephedrine.  What other impacts could the loperamide packaging change have?  What other patient safety actions are warranted for loperamide?


Posted January 2020

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