FDA to Limit Amount of Doses in OTC Antidiarrheal Packages

The Food and Drug Administration (FDA) announced steps to limit the number of doses in a package for loperamide, an over-the-counter (OTC) antidiarrheal medication. 

Loperamide is currently approved to help manage the symptoms of diarrhea, including Travelers’ Diarrhea. It works on the opioid receptors in the gut to slow movement in the intestines and reduce the number of bowel movements. The maximum daily dose is 8mg for adults as OTC use and 16mg as prescription use. When consumed at much higher than recommended doses, patients can experience cardiotoxicity and even death. 

There have been ongoing reports of serious heart problems and deaths associated with loperamide doses that are much higher than what is recommended. These cases mainly involved individuals who are intentionally misusing or abusing the drug despite a 2016 safety communication from the FDA and an added warning to the drug label. 

Loperamide is marketed OTC under the brand name Imodium A-D; it is also available as store brands and generic versions. The FDA will be working with manufacturers to use blister packs or other single-dose packaging in efforts to limit the number of doses in a package.

Healthcare professionals should be aware of serious cardiac events (eg, QT prolongation, Torsades de Pointes, ventricular arrhythmias, syncope, cardiac arrest) associated with intentional or unintentional ingestion of high loperamide doses. Abusers typically use other medications together to increase its absorption and penetration across the blood-brain barrier, ultimately affecting loperamide metabolism and increasing its euphoric effects. 

If loperamide toxicity is suspected, patient should discontinue use immediately and receive appropriate therapy. 

For more information call (855) 543-3784 or visit FDA.gov.