New Safety Measures Announced for Extended-release and Long-acting Opioids
[8-25-2020] FDA posted the final reviews of seven fulfilled PMRs that were announced on 2-4-2016 to assess the known serious risks of misuse, abuse, addiction, overdose, and death.
[9/18/2018] FDA approved the Opioid Analgesic REMS, which applies to all opioid analgesics intended for outpatient use. The REMS program requires that training be made available to all health care providers who are involved in the management of patients with pain, including nurses and pharmacists. The agency also approved the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain (Blueprint), as well as safety labeling changes that require companies to include new safety information regarding the Opioid Analgesic REMS in the Boxed Warning and Warnings and Precautions sections of prescribing information.
[6-1-2018] FDA sent safety labeling change notification letters to drug companies with approved opioid analgesic products intended for use in an outpatient setting. The letters require these companies to include new safety information regarding the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) in the Boxed Warning and Warnings and Precautions sections of prescribing information due to a general lack of awareness of the REMS among all opioid analgesic prescribers.
[5-11-2017] FDA released the original postmarketing requirement (PMR) for some abuse-deterrent (AD) opioids to show that the properties intended to deter misuse and abuse of the product actually result in a meaningful decrease in misuse and abuse, and their related clinical outcomes of addiction, overdose, and death, in post-approval settings. It will be replaced with a two-phased study approach in order to obtain the data needed to fulfill the PMR because the agency has determined that a sequential approach will be more responsive to the uncertainties inherent to this situation – namely, a study that is dependent on adequate uptake of the product in the market.
[2-4-2016] FDA released five postmarketing (PMR) requirements announced on September 13, 2013 and replaced them with eleven PMRs (ten postmarketing studies and one clinical trial) because the ten postmarketing observational studies and one clinical trial include refined measures for assessing the known serious risks of misuse, abuse, addiction, overdose, and death.
[4-16-2014] FDA approved class-wide labeling changes for all extended-release and long-acting (ER/LA) opioid analgesics announced on September 10, 2013, and responded to two petitions regarding labeling for neonatal opioid withdrawal syndrome (NOWS).
[9-10-2013] FDA announced a set of significant measures to enhance the safe and appropriate use of extended-release and long-acting (ER/LA) opioids. These actions include proposed class-wide safety labeling changes and new postmarket requirements for all ER/LA opioid analgesics. FDA also responded to two citizen petitions.
August 25, 2020
- PMR 3033-3-4-5 Final Review (PDF - 3 MB)
- PMR 3033-7 Final Review (PDF - 1 MB)
- PMR 3033-8 Final Review (PDF - 1 MB)
- PMR 3033-9 Final Review (PDF - 3 MB)
- PMR 3033-10 Final Review (PDF - 1 MB)
June 1, 2018
May 11, 2017
February 4, 2016
April 16, 2014
- FDA Response to Petitions: National Advocates for Pregnant Women (NAPW)
- ER/LA Opioid Analgesic Class Labeling Supplement Approval
September 10, 2013
- ER/LA Opioid Analgesic Class Labeling Changes and Postmarket Requirements
- FDA Response to Citizen Petition: Physicians for Responsible Opioid Prescribing (PROP). Docket ID FDA-2012-P-0818
- FDA Response to Citizen Petition: Kirk Van Rooyan and Barbara Van Rooyan. Docket ID FDA-2005-P-0325.
- Crafting Better Drug Labeling to Ensure Safer Use of Opioids