FDA Moves to Limit Loperamide Doses per Package


Aimed at discouraging use of the drug to ease opioid withdrawal symptoms

Following numerous reports of people taking large and sometimes toxic doses of loperamide (Imodium) to relieve symptoms of opioid withdrawal or to obtain an opioid high, the FDA said it’s working with manufacturers to alter packaging, including limits to the number of doses in a package.

Loperamide is an opioid receptor agonist that works primarily in the bowel. It is sold over the counter for treatment of diarrhea, and can be purchased in bottles containing as many as 200 caplets.

 An earlier FDA warning, issued in June 2016, noted 48 cases of serious cardiac events associated with loperamide reported to the agency from 1976 to 2015. Numerous websites offering advice on self-treatment for opioid withdrawal have advocated taking loperamide at doses of up to 60 mg/day. The FDA-recommended dose for diarrhea is 8-16 mg/day.

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