FDA Adds Boldest Warning to Most Widely Used (prescribed) Painkillers

Last edited Mon Mar 28, 2016, 03:55 AM - Edit history (1)

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FDA Adds Boldest Warning to Most Widely Used Painkillers
Wed Mar 23, 2016
BY MATTHEW PERRONE
AP HEALTH WRITER

WASHINGTON (AP) -- Federal health regulators will add their strongest warning labels to the most widely prescribed painkillers, part of a multi-pronged government campaign to stem an epidemic of abuse and death tied to drugs like Vicodin and Percocet.

The Food and Drug Administration announced Tuesday plans to add a boxed warning - the most serious type - to all immediate-release opioid painkillers, including some 175 branded and generic drugs.

Those medications, which often combine oxycodone with lower-grade medications, are among the most commonly used drugs in the U.S. and account for 90 percent of all opioid painkillers prescribed. Roughly three years ago the FDA added similar warnings to long-acting opioid drugs like OxyContin, which slowly release their doses over 12 hours or more. Now both immediate and extended-release formulations will highlight the risks of addiction, abuse, overdose and death.

The long-awaited changes come as federal and state officials struggle to curb a wave of overdoses fueled by the overprescribing of medications and a steady supply of cheap heroin.