US Pharm. 2016;41(4):12.

Silver Spring, MD—The FDA has announced required classwide safety labeling changes for immediate-release (IR) opioid pain medications, including morphine, oxycodone, and hydrocodone. These updates include a new boxed warning about the serious risks of misuse, abuse, addiction, overdose, and death. There is also a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening. Because of these risks, IR opioids should only be reserved for severe pain that is not adequately treated by other options. These latest actions are part of the FDA’s overall effort to help inform prescribers about the importance of balancing the serious risks of opioids with their role in managing pain.

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