New Safety Measures Announced for Extended-Release and Long-Acting Opioids

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: New Safety Measures Announced for Extended-Release and Long-Acting Opioids

	September 2013 www.fda.gov/womens New Safety Measures Announced for Extended-Release and Long-Acting Opioids The FDA today announced class-wide safety labeling changes and new postmarket study requirements for all extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain. The FDA is also 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 (NOWS). NOWS can occur in a newborn exposed to opioid drugs while in the mother’s womb. New safety information Press release     Please share this update with your network, members, constituents, and community.   FDA Office of Women’s Health   10903 New Hampshire Avenue   WO32 - Room 2333   Silver Spring, MD   20993-0002   301-796-9440

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