Smaller OTC Loperamide Packages Wait As Retailers Limit Purchase Amounts
This article was originally published in The Pink Sheet & The Rose Sheet
Executive Summary
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.
You may also be interested in...
OTC Loperamide Cardiovascular Label Warnings In US Spread To Perrigo Products
FDA approval for Perrigo's ANDA for two loperamide products listed as tablets follows CBE label changes Johnson & Johnson and BionPharma made for their branded OTCs containing the ingredient in 2019.
Health Market News: Acetaminophen Prop 65 Report Posted; Loperamide Brands' Smaller Packaging
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.
FDA Looks At OTC Loperamide Packaging To Curb Opioid-Related Abuse
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.