FDA announced new action to combat the growing problem of abuse and misuse of the opioid-based antidiarrheal medication loperamide (Imodium).

In 2016, the FDA warned about life-threatening cardiac events, including QT interval prolongation, torsades de pointes or other ventricular arrhythmias, syncope, and cardiac arrest, with loperamide misuse and abuse.

The FDA notes that some individuals are taking higher-than-recommended doses of loperamide to treat symptoms of opioid withdrawal or to achieve euphoric effects of opioid use.

The maximum approved daily dose for adults is 8 mg/day for OTC use and 16 mg/day for prescription use. Loperamide is safe at these approved doses.

Evidence suggests that package limitations and use of unit-dose packaging may reduce medication overdose and death.