FDA takes steps to curb misuse / abuse of OTC antidiarrheal drug

FDA announced Tuesday a new action to combat the increasing problem of misuse and abuse of the OTC antidiarrheal drug loperamide. When used at very high and dangerous doses, the drug may be used by some individuals as a way to manage opioid withdrawal symptoms or to achieve the euphoric effects of opioid use. FDA is requesting that manufacturers of OTC loperamide "change the way they label and package these drugs to stem abuse and misuse that leaves us deeply concerned," FDA Commissioner Scott Gottlieb, MD, said. While loperamide is safe at approved doses, there have been reports of serious heart problems and deaths with higher-than-recommended doses of the drug, primarily among individuals who were intentionally misusing and abusing high doses of loperamide. "We're requesting that packages contain a limited amount of loperamide appropriate for use for short-term diarrhea according to the product label," Gottlieb said.