FDA Warns of Danger from Anti-Diarrhea Drug Overdoses

Federal health officials are investigating sometimes-deadly overdoses with common anti-diarrhea drugs, a bizarre manifestation of the nation’s drug abuse problem.
The primary ingredient in prescription Imodium and similar over-the-counter drugs is intended to control diarrhea. But abusers sometimes try to achieve heroin-like highs by taking massive doses, up to 300 milligrams at once, according to cases in the medical literature. Recommended doses range between 8 milligrams and 16 milligrams per day.
Many are accidental overdoses but people also report taking the drug, called Imodium, on purpose to help curb cravings for highly addictive opioid drugs.Imodium, known generically as loperamide can cause deadly heart problems, the FDA said.
“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 agency said in a statement.
High doses of the inexpensive and widely available medicine can make patients feel a high, said Dr. William Eggleston, a toxicologist at SUNY Upstate Medical Center, who helped write a report published in the Annals of Emergency Medicine about two men who died after abusing Imodium. The researchers recommended tighter control on the drug.
“Action should be taken to regulate the sale of loperamide-containing products in a manner similar to pseudoephedrine, dextromethorphan, and other restricted over-the-counter medications,” they wrote.
FDA officials are thinking about it.
“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. We continue to evaluate this safety issue and will determine if additional FDA actions are needed,” the FDA said.
The FDA recommended that people call 911 immediately if someone taking Imodium faints, has a fast or irregular heartbeat or cannot be woken up.
“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,” the FDA said.
“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. This number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware.”
Ten of the people died, FDA said. Drugs that can interact badly with Imodium include some antibiotics and the antacid Tagamet.