Prescription opioids are powerful pain-reducing medications that include prescription oxycodone, hydrocodone and morphine, among others, and have both benefits as well as potentially serious risks. These medications can help manage pain when prescribed for the right condition and when used properly. But when misused or abused, they can cause serious harm, including addiction, overdose and death.
Recently, too many citizens have been impacted by the serious harms associated with these medications. In response to the current opioid crisis facing our country, FDA has developed a comprehensive action plan to take concrete steps toward reducing the impact of opioid misuse and abuse. For the latest information on FDA actions related to opioid medications please see the sections and links below.
- Draft Guidance Issued: General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drugs
- New Safety Measures Announced for Immediate Release (IR) Opioids
- Press Release: Califf, FDA top officials call for sweeping review of agency opioids policies
- FDA Voice - Changing course: A new approach to opioid pain medication at FDA
- In response to the current opioid crisis the FDA has established a far-reaching action plan to reassess the agency’s approach to opioid medications. The plan focuses on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.
- To help combat the opioid epidemic, the FDA is also encouraging efforts to make it harder or less rewarding to abuse opioids. On March 24, 2016 FDA issued a draft guidance titled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products .” This guidance recommends studies a generic applicant should conduct so FDA can evaluate the abuse deterrence of certain generic opioid drug products and help ensure that generic versions of approved opioids with abuse-deterrent formulations (ADFs) are no less abuse-deterrent than the brand named drug.
- Opioid medications have the potential to provide significant pain-relieving benefit for patients when used as directed for their approved indications; however, opioids also carry serious risks of misuse, abuse, neonatal opioid withdrawal syndrome (NOWS), addiction, overdose, and death. FDA has been actively working to find ways to mitigate these serious risks associated with the use of opioids, while continuing to ensure that patients in pain have appropriate access to these products.
- There are two primary categories of opioid medications: immediate release (IR) , which are the most often prescribed type of opioid, and extended-release /long-acting (ER/LA). The labeling for both have recently received multiple updates to more effectively communicate to prescribers the serious risks associated with these drugs.
- FDA has approved a number of drug products that address opioid addiction or overdose. Methadone and buprenorphine products are part of the class of extended-release and long-acting (ER/LA) opioids and are approved for the treatment of opioid addiction. This type of treatment is often referred to as medication-assisted treatment (MAT). Regarding overdose, in November 2015 the FDA approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose. Also, in April 2014, the FDA approved a prescription naloxone hydrochloride injection, which can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. This formulation rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet.
- Annually approximately 100 million people in the United States suffer from pain and 9 million to 12 million of them have chronic or persistent pain, while the remainder have short-term pain from injuries, illnesses, or medical procedures. All of patients in pain should benefit from skillful and appropriate pain management, which may include the judicious use of opioid medicines in conjunction with other methods of treatment or in circumstances in which nonaddictive therapies are insufficient to control pain. Clearly, though, more research on pain control is warranted. The FDA applauds the work done by the U.S. Department of Health and Human Services and the entire Interagency Pain Research Coordinating Committee to further efforts to encourage more research and awareness of the management of chronic pain. We are also working with NIDA to encourage the development of nonaddictive pain medications.
- In February 2016, FDA leadership authored a Special Report published in the New England Journal of Medicine, which put forth a broad range of immediate and specific actions to help address opioid abuse. In this report FDA committed to: reassessing the risk/benefit analysis FDA applies to opioid drug product approvals, gaining expert input from Advisory Boards and the Scientific Board at FDA, reviewing label and postmarket requirements, prioritizing abuse-deterrent formulations and overdose treatments and supporting a range of research efforts in areas such as pain management in children and the development of non-opioid alternatives for pain management.
- Currently, Extended-Release and Long-Acting (ER/LA) Opioids are subject to Risk Evaluation and Mitigation Strategy (REMS) program. A REMS program may be required by the FDA as part of the approval of a new product, or for an approved product when new safety information arises. Essentially, a REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use. On May 3 and 4, 2016, FDA Advisory Committees will discuss results from assessments of the ER/LA Opioid Analgesics REMS.
- The FDA has compiled a timeline to provide chronological information about agency activities and significant events related to opioids. Included on this page is a summary timeline of key events, followed by tabbed years that provide selected additional actions and more detail about the items listed in the summary.
FDA Issues Draft Guidance on Abuse-Deterrent Formulations of Generic Opioids New Safety Measures Announced for Immediate Release (IR) Opioids New Safety Measures Announced for Extended-release and Long-acting Opioids Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids FDA Statement in Support of the 2013 National Drug Control Strategy
Safe Disposal of Medicines
- The New England Journal of Medicine Special Report: A Proactive Response to Prescription Opioid Abuse