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FDA Announces Safety Labeling Changes for Long-Acting Opioids

October 16, 2013

The U.S. Food and Drug Administration (FDA) announced new labeling guidelines and study requirements for all extended-release and long-acting (ER/LA) opioid pain relievers.

Labeling changes will further clarify the health risks associated with ER/LA opioids, including addiction, abuse, and misuse of doses. New language will also be added to help health care professionals tailor their prescribing decisions to a patient's individual needs.

A new boxed warning will also be added to identify risks of ER/LA opioids during pregnancy, such as neonatal opioid withdrawal syndrome, which could be life-threatening for newborns.

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