FDA Outlines Heart Problems Associated With Antidiarrhea Pill

June 22, 2016

On June 7, the U.S. Food and Drug Administration warned about the heart problems associated with loperamide, an antidiarrhea pill with addictive properties.

Taking higher than the recommended dosage “can cause serious heart problems that can lead to death,” the agency noted in a statement. These risks include cardiac arrhythmias, or irregular heartbeat, and serious cardiac events, which can be fatal.

The statement from the FDA explained that these reported heart problems resulted from the intentional misuse of the drug for the purposes of treating opioid withdrawal symptoms and getting high.

In recent months, loperamide has been linked to cases of QT interval prolongation, Torsades de Pointes or other ventricular arrhythmias, syncope, and cardiac arrest. Misuse often includes other drugs, such as ranitidine, to boost the drug’s euphoric effects.

The maximum daily dosage is 8 mg per day for adult OTC users and 16 mg for prescription users. The FDA urges patients who are unsure about proper dosages to contact a health care professional and to tell their physicians about other medicines they are taking, by prescription or OTC.

Loperamide was introduced in 1976 as a controlled substance to relieve diarrhea symptoms. Twelve years later, researchers found the odds of abuse to be low and reclassified the drug to over-the-counter status.

The drug is sold over the counter as Imodium and Diamode. Retailers sell as many as 400 caplets for less than $8. Its accessibility and low cost have led those with opioid addictions to the drug.

In recent years, it has been called “poor man’s methadone,” because of its addictive properties.

Loperamide Adverse Events Reports

The drug has been linked to 48 cases of serious heart problems between 1976 and 2015, per the FDA, 31 of which resulted in hospitalizations. Ten deaths have been reported to the FDA, and additional unreported cases may exist.

In the last two years, loperamide overdose has caused more than a dozen deaths or life-threatening irregular heartbeats in five states, according to the New York Times. A New York man died after taking 25 times the recommended dosage. Another man died after treating his opioid addiction with loperamide.

Additional health problems may be associated with the drug. The FDA stated, “We continue to evaluate this safety issue and will determine if additional FDA actions are needed.”

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View Sources

• Phend, C. (2016, June 7). FDA Warns of Heart Risk with Loperamide Overdose. Retrieved from http://www.medpagetoday.com/Cardiology/Arrhythmias/58365?isalert=1&uun=g947102d5074R7879559u&xid=NL_breakingnews_2016-06-07
• Saint Louis, C. (2016, May 13). Addicts Who Can’t Find Painkillers Turn to Anti-Diarrhea Drugs. Retrieved from http://www.nytimes.com/2016/05/11/health/imodium-opioid-addiction.html?_r=0
• U.S. Food and Drug Administration. (2016, June 8). FDA Drug Safety Communication: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse [Press Release]. Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm504617.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
• U.S. Food and Drug Administration. (2016, June 7). Loperamide (Imodium): Drug Safety Communication - Serious Heart Problems With High Doses From Abuse and Misuse [Press Release]. Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm505303.htm

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