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News From the Food and Drug Administration
May 3, 2016

Boxed Warning for Most Opioids

JAMA. 2016;315(17):1826. doi:10.1001/jama.2016.4482

In a related step to tackle opioid abuse, the FDA recently announced labeling changes, including a boxed warning, for immediate-release (IR) opioid pain medications. The changes will affect more than 200 opioid-containing products, FDA officials said during a media briefing.

“I can’t stress enough how critical it is for prescribers to have the most current information about the potential risks these products pose to both patients and nonpatients,” FDA Commissioner Robert Califf, MD, said during the briefing (http://1.usa.gov/1MF96rY).

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