FDA takes steps to help prevent new addiction, curb abuse and overdose related to opioid products

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 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. "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." FDA also announced it has posted the revised and updated "Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain." The includes core educational messages for health care providers involved in the treatment and monitoring of patients with pain. Additionally, it features more information on pain management, such as the principles of acute and chronic pain management; non-pharmacologic treatments for pain; and pharmacologic treatments for pain. Although these steps are intended to help ensure appropriate use of opioids, Gottlieb noted "there is much more to do and we are mindful that any intervention the FDA considers should minimize the burden on appropriate patient access and, to the extent practicable, on the delivery system." He stressed that stakeholder feedback is important, and said that, following Tuesday's Part 15 hearing on curbing overprescribing of opioids, public comments will be accepted until March 16, 2018.