FDA Places Loperamide HCl-containing products (Imodium) on Watchlist

Washington, DC: The Food and Drug Administration (FDA) has placed Loperamide HCl-containing products (Imodium) on its Adverse Event Reporting System (AERS) watchlist, due to potential signals of serious risks/new safety information that were identified for this product.

Specifically, the FDA is monitoring Loperamide HCl-containing products (Imodium) for reports of pancreatitis, which involves inflammation of the pancreas and can be serious. Pancreatitis can affect adults as well as children, and chronic disease can lead to the development of gallstones. Signs and symptoms of acute and chronic pancreatitis include pain in the abdomen.

The FDA is continuing to evaluate this issue and any potential association with Loperamide HCl-containing products (Imodium) to determine the need for any regulatory action.

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Published on Apr-25-12