FDA Adds Black-Box Warning To Opioids

Law360, New York (March 22, 2016, 1:29 PM EDT) -- The U.S. Food and Drug Administration said Tuesday it will now require black-box warnings on immediate-release opioids highlighting the risk of “misuse, abuse, addiction, overdose and death,” to combat what the agency described as an epidemic of addiction. 

Prescriptions including oxycodone, hydrocodone and morphine will now have to state that they are only for patients with severe enough pain to justify opioids and for which other treatments were not sufficient or tolerated, the FDA said. The update will also clarify dosage instructions, including how much should be given initially, how that dosage should be changed and a warning against suddenly stopping...

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