Loperamide (Imodium): Drug Safety Communication – Serious Heart Problems With High Doses From Abuse and Misuse
ISSUE:
FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), 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 (see Examples of Drugs that Can Potentially Interact with Loperamide, in the FDA Drug Safety Communication).
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. FDA continues to evaluate this safety issue and will determine if additional FDA actions are needed.
BACKGROUND:
Loperamide is approved to help control symptoms of diarrhea, including Travelers’ Diarrhea. The maximum approved daily dose for adults is 8 mg per day for OTC use and 16 mg per day for prescription use. It is sold under the OTC brand name Imodium A-D, as store brands, and as generics. See the FDA Drug Safety Communication for data summary.
RECOMMENDATION:
Health care professionals should be aware that use of higher than recommended doses of loperamide can result in serious cardiac adverse events. Consider loperamide as a possible cause of unexplained cardiac events including QT interval prolongation, Torsades de Pointes or other ventricular arrhythmias, syncope, and cardiac arrest. In cases of abuse, individuals often use other drugs together with loperamide in attempts to increase its absorption and penetration across the blood-brain barrier, inhibit loperamide metabolism, and enhance its euphoric effects. If loperamide toxicity is suspected, promptly discontinue the drug and start necessary therapy. If loperamide ingestion is suspected, measure blood levels, which may require specific testing. For some cases of Torsades de Pointes in which drug treatment is ineffective, electrical pacing or cardioversion may be required. Refer patients with opioid use disorders for treatment (see Additional Information for Health Care Professionals in the FDA Drug Safety Communication).
Click here to read the MedWatch safety alert, including a link to the FDA Drug Safety Communication.
Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news!
