The US Food and Drug Administration (FDA) announced new action today to combat the growing problem of abuse and misuse of the over-the-counter (OTC), opioid-based antidiarrheal medication loperamide (Imodium, Johnson & Johnson), which is placing individuals at risk for cardiac dysrhythmia and death.
To foster safe use of loperamide, the FDA is working with manufacturers to use blister packs or other single-dose packaging and to limit the number of doses in a package, the agency said.
The FDA is asking manufacturers of loperamide, which is available OTC and by prescription, to change the way they label and package loperamide to “stem abuse and misuse that leaves us deeply concerned,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
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, as reported by Medscape Medical News. In 2017, the FDA added a warning to the product label about the risk of taking high doses of loperamide.
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, but the FDA continues to receive reports of serious cardiac problems and deaths with much higher than the recommended doses of loperamide, primarily among people who are intentionally misusing or abusing the product, the agency said.
Packaging Could Help
Evidence suggests that package limitations and use of unit-dose packaging may reduce medication overdose and death, Dr Gottlieb said. Today the agency sent letters to OTC manufacturers requesting that they implement changes consisting of packaging limitations and unit-of-dose packaging.
“We’re requesting that packages contain a limited amount of loperamide appropriate for use for short-term diarrhea according to the product label. One example is a single retail package containing eight 2-milligram capsules in blister packaging. We asked the manufacturers to take the necessary steps to implement these changes in a timely fashion to address these public health concerns,” Dr Gottlieb said.
He said the FDA will also reach out to those who distribute loperamide online through retail websites to ask them to take voluntary steps to help address the problem of loperamide abuse. “The abuse of loperamide requires the purchase of extremely large quantities. Often this is done through the purchase of large bottles of loperamide, which is a common configuration in which the pill form of the medication is currently packaged. Today’s action is intended to change how the product is packaged, to eliminate these large volume containers. We know that many of the bulk purchases of these large volumes are being made online through major online web retailers,” Dr Gottlieb explained.
To report any problems with loperamide, contact MedWatch, the FDA’s safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at http://ift.tt/KHxbBZ; with postage-paid FDA form 3500, available at http://ift.tt/1412xto; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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