New Safety Measures Announced for Immediate Release (IR) Opioids
[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.
[3-22-16] In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the U.S. Food and Drug Administration today announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse and abuse, which can lead to addiction, overdose and death. Today’s actions are among a number of steps the Agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the prescription opioid abuse epidemic, while still providing patients in pain access to effective relief.
June 1, 2018
- Template Letter for Safety Labeling Change Notification (PDF - 325KB)
March 22, 2016
- FDA news release: FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death
New safety warnings also added to all prescription opioid medications to inform prescribers and patients of additional risks related to opioid use
- FDA Drug Safety Communication: FDA warns about several safety issues with opioid pain medicines; requires label changes
- Example letter to IR opioid application holder
Due to the complexity of these actions and the scope of changes being made in different categories of opioid medications, FDA is posting an example sponsor letter that best captures the breadth of the announced safety labeling changes.
- Example IR opioid labeling template
Due to the complexity of these actions and the scope of changes being made in different categories of opioid medications, FDA is posting an example labeling template that best captures the breadth of the announced safety changes. Each sponsor is required to insert information relevant to each product.
- FDA Response to Citizen Petition: Purdue Pharma, L.P., Docket ID FDA-2014-P-0205
The petition requests that FDA impose safety labeling changes on immediate-release opioid analgesics that parallel the safety labeling changes to extended-release/long-acting opioid analgesics that FDA required in 2013, and that the indications and other safety labeling information for both classes of drugs convey the same warnings and precautions.
- FDA Response to 5 Citizen Petitions regarding tramadol products (Docket IDs. FDA-2005-P-0425, FDA-2005-P-0054, FDA-2005-P-0058, FDA-2005-P-0191 and FDA-2005-P-0055)
The five Petitions request that FDA recommend scheduling tramadol under the Controlled Substances Act. Two of the five petitions also request that FDA re-evaluate labeling for new tramadol formulations in light of currently available safety information.