Resources for You
New Safety Measures Announced for Extended-release and Long-acting Opioids
FDA announces 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.
FDA announces safety labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics
FDA news release (9/10/2013)
ER/LA Opioid Analgesic Class Labeling Changes and Postmarket Requirements(PDF - 136KB)
Letter to ER/LA opioid application holders
FDA Response to Citizen Petition: Physicians for Responsible Opioid Prescribing (PROP). Docket ID FDA-2012-P-0818
The petition requests an indication change for all opioids, and limits on maximum daily dose and maximum duration of use for all opioids.
FDA Response to Citizen Petition: Kirk Van Rooyan and Barbara Van Rooyan. Docket ID FDA-2005-P-0325.
The petition requests withdrawal of old OxyContin and Palladone and limits on their indications.
Goal of Label Changes: Better Prescribing, Safer Use of Opioids
FDA Consumer Update article (9/10/2013)
Crafting Better Drug Labeling to Ensure Safer Use of Opioids
FDA Voice Blog (9/10/2013)