Smaller OTC Loperamide Packages Wait As Retailers Limit Purchase Amounts
This article was originally published in The Pink Sheet & The Rose Sheet
Commissioner Scott Gottlieb updates US FDA's initiative to prevent potentially fatal abuse of OTC loperamide, noting that online and conventional retailers are limiting product purchases while the agency continues evaluating the appropriate number of doses per package.
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Brand-name loperamide OTCs will be packaged in single doses with no more than 48 mg per container; and California posts acetaminophen hazard identification for Prop 65 consideration.
Ingredient in J&J's Imodium and numerous OTC generics acts on opioid receptors in the gut to slow movement in the intestines and decrease bowel movements, but dosing at much higher than recommended amounts can lead to serious problems including severe heart rhythm problems and death.