FDA adds boldest warning to most widely-used painkillers
WASHINGTON (AP) — Federal health regulators will add their strongest warning labels to the most widely used prescription painkillers, part of a multi-pronged government campaign to reverse 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, which include more than 220 branded and generic drugs.
The labeling switch means both immediate and extended-release formulations will carry information highlighting the risks of addiction, abuse, overdose and death.
Throckmorton said the agency's previous labeling change focused on long-acting drugs like OxyContin because they represented a "disproportionate risk" to patients, since they contain larger opioid levels.
The agency said primary care doctors should only turn to opioids after considering physical therapy, over-the-counter medications, counseling and other methods for treating chronic pain.