FDA adds boldest warning label to most-widely used opioid painkillers

Associated Press

WASHINGTON

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 such as 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 such as 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.