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FDA Approves New Packaging Limits for Loperamide
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The FDA has approved new package size and type limits for the over-the-counter, brand-name tablet and capsule forms of loperamide, a diarrhea drug, restricting each carton to no more than 48 mg and requiring unit-dose blister packaging.
According to the FDA announcement, the new changes are intended to address the issue of loperamide abuse and misuse, stating that serious adverse cardiac events, some leading to death, can occur after taking high doses of the drug.
The new packaging limits apply to the brands Imodium A-D (Johnson & Johnson), Imodium Multi-Symptom Relief (Johnson & Johnson) and Be Health Loperamide HCl Capsules (Bionpharma).
The maximum approved daily dose for loperamide is 8 mg in its over-the-counter forms and 16 mg for prescription use. Although the FDA states that the drug is safe at approved doses, the administration has reported cases of serious heart problems and deaths associated with loperamide, the majority of which have been attributed to intentional misuse and abuse. The FDA in 2017 added a Heart Alert to loperamide’s drug facts labels, warning that higher doses can cause serious heart problems or death.
Later, in 2018, the FDA requested that manufacturers and packagers of over-the-counter loperamide products alter the way they label and package loperamide to support safe use.
The administration in 2016 stated that loperamide misuse and abuse appear to be related to the ongoing epidemic of opioid abuse, with individuals attempting to use the drug to treat opioid-withdrawal symptoms or achieve a feeling of euphoria.