Loperamide Abuse Triggers Look At Potential Label Warning

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.

FDA's Center for Drug Evaluation and Research warns consumers about taking more of the anti-diarrheal drug loperamide than indicated, the center's second warning about a common OTC ingredient in as many days.

Monitoring reports of adverse events, including 10 deaths, prompts concern about the ingredient used in OTCs including McNeil Consumer Healthcare's Imodium A-D and in private label and store brand...

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