FDA Beefs Up Warning Requirements for Opioids

A new, boxed warning will be included with immediate-release prescription opioids, and all opioid drugs will come with expanded safety information under new requirements from the U.S. Food and Drug Administration. Immediate-release opioids will now include a “black box” warning, similar to the warning that comes with extended-release opioids. It will caution prescribers and patients about the serious risks of misuse, abuse, addiction, overdose and death, the FDA announced Tuesday. The black box is used to emphasize serious or life-threatening risks. The agency said the measures a...