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FDA announces safety labeling changes for certain opioid pain relievers

September 10, 2013

The Food and Drug Administration today announced class-wide safety labeling changes and new postmarket study requirements for all extended-release and long-acting opioid analgesics intended to treat pain. The updated indication states that ER/LA opioids are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. FDA also is requiring a new boxed warning on ER/LA opioid analgesics to caution that chronic maternal use of these products during pregnancy can result in neonatal opioid withdrawal syndrome. Once the safety labeling changes are finalized, modifications will be made to the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy to reflect the updated information. Approved last year, the REMS requires companies to make available to health care professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide medication guides and patient counseling documents on the safe use, storage and disposal of ER/ LA opioids.