FDA warns against higher-than-recommended doses of OTC diarrhea medicine loperamide

SILVER SPRING, Md. - The U.S. Food and Drug Administration on Tuesday warned that taking higher than recommended doses of the common over-the-counter and prescription diarrhea medicine loperamide (the main ingredient in Imodium, for example), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. 

 

The risk of these serious heart problems, including abnormal heart rhythms, may also be increased when high doses of loperamide are taken with several kinds of medicines that interact with loperamide. 

 

The majority of reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria, the FDA reported.

 

In the 39 years from when loperamide was first approved in 1976 through 2015, FDA received reports of 48 cases of serious heart problems associated with use of loperamide. Thirty-one of these cases resulted in hospitalizations, and 10 patients died. 

 

More than half of the 48 cases were reported after 2010. 

 

The serious heart problems occurred mostly in patients who were taking doses that were much higher than recommended. In other cases, patients were taking the recommended dose of loperamide, but they were also taking interacting medicines, causing an increase in loperamide levels. 

 

"Millions of consumers use over-the-counter medicines containing loperamide to treat symptoms of diarrhea without an unnecessary doctor’s visit, and these consumers should rest assured that this medicine is safe and effective when used according to the Drug Facts label," stated the Consumer Healthcre Products Association. "As noted in the FDA Drug Safety Communication, the majority of the 48 cases of heart problems associated with loperamide reported from 1976 to 2015 occurred in individuals who were taking doses much higher than the recommended dose or deliberately misusing other drugs along with loperamide. As with any medicine, abuse and unintentional misuse can lead to side effects, and the FDA communication serves as a reminder to consumers to always read and follow the Drug Facts label."

 

Through the CHPA Educational Foundation, the OTC industry is committed to empowering and encouraging consumers to select and use OTC medicines safely through websites like KnowYourOTCs.org.