FDA Acts to Stem Misuse, Abuse of Antidiarrheal Loperamide
Megan Brooks 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, ...