Loperamide Abuse Triggers Look At Potential Label Warning
This article was originally published in The Tan Sheet
Monitoring of AERs prompts concern about the ingredient used in OTC anti-diarrheal products, CDER says a day after it noted adverse event reports in announcing concerns about a risk of serious bleeding linked to use of OTC antacid/aspirin products.
You may also be interested in...
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.
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.