New Safety Measures Announced for Extended-release and Long-acting Opioids

[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.

February 4, 2016

September 10, 2013

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