FDA Orders Warnings on Narcotic Painkillers
Immediate-release versions of addictive meds such as Oxycontin, Percocet and Vicodin to be affected
By E.J. Mundell and Steven Reinberg
TUESDAY, March 22, 2016 (HealthDay News) -- Hoping to curb a national epidemic of prescription painkiller abuse, U.S. officials on Tuesday announced that certain drugs will get new "boxed warnings" about the dangers of misuse.
The move by the U.S. Food and Drug Administration comes one week after the U.S. Centers for Disease Control and Prevention announced tough new guidelines to doctors for "opioid" drugs such as Oxycontin, Percocet and Vicodin.
"We are at a time when the unfathomable tragedies resulting from addiction, overdose and death has become one of the most urgent, devastating public health crises facing our country," FDA Commissioner Dr. Robert Califf told reporters at a Tuesday news briefing.
He said the agency is working with other agencies, drug makers, doctors and patients "to prevent abuse, save lives and treat dependence while still providing patients in pain access to effective relief."
The new labeling rules are mostly aimed at highly addictive "immediate-release" versions of narcotic painkillers. According to an FDA news release, the new label requirements include:
- A new boxed warning on the "serious risks of misuse, abuse, addiction, overdose and death."
- A new prescribing guideline that immediate-release opioids "should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options are inadequate or not tolerated."
- Labeling stressing the risk of "neonatal opioid withdrawal syndrome" in babies born to mothers who took opioid painkillers during their pregnancy.
Besides this new labeling for immediate-release narcotic painkillers, the FDA is also mandating other revised labeling for all opioids -- even extended-release versions.
All of these drugs will now include information on labels warning of potential harmful interactions of the drug with other medicines "that can result in a serious central nervous system condition called serotonin syndrome," the agency said.
Labels will also warn of possible glandular or hormonal changes linked to opioid use.
The new rules come after CDC action on prescription painkillers, announced March 15. The CDC advisory stressed that doctors -- especially primary care physicians -- should try to avoid addictive "opioid" painkillers whenever possible for patients with most forms of chronic pain.