FDA Adds Boldest Warning to Widely Used Opioid Painkillers
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 like Vicodin and Percocet.
The Food and Drug Administration announced on 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.
The long-awaited change comes roughly three years after the FDA added similar warnings to long-acting opioid drugs like OxyContin, which slowly release their doses over 12 hours or more. The labeling switch means both immediate and extended-release formulations will now highlight the risks of addiction, abuse, overdose and death.
“We’re at a time when the unfathomable tragedies resulting from addiction, overdose and death have become one of the most urgent and devastating public health crises facing our country,” FDA Commissioner Robert Califf said in a call with reporters. “I can’t stress enough how critical it is for prescribers to have the most current information.”
But lawmakers from states that have been ravaged by opioid addiction said such labeling changes have done little to help their communities.
“Unfortunately, it has taken the FDA far too long to address the grave risks of these drugs that have claimed the lives of thousands this year alone,” said Sen. Edward Markey, D-Mass.
Opioids are a class of powerful and highly addictive drugs that include both prescription drugs like codeine and hydrocodone, as well as illegal narcotics, like heroin.
Deaths linked to misuse and abuse of prescription opioids climbed to 19,000 in 2014, the highest figure on record, according to the Centers for Disease Control and Prevention. Heroin and opioid painkillers combined caused 28,650 fatal overdoses.
Doctors are not required to follow the FDA’s instructions on drug labels, though they are often used as prescribing guidelines by hospitals, medical groups and insurers.
Critics of the FDA, including Physicians for Responsible Opioid Prescribing, called on the agency to add such warnings years ago.
“The main driver of our opioid epidemic is addiction, and the immediate-release products are just as addictive,” said the group’s founder Andrew Kolodny, an addiction therapist with Phoenix House, a network of rehabilitation clinics.
The new FDA label will specify that drugs like Percocet should only be used when other medications and alternative therapies cannot control patients’ pain.
“This new indication, once finalized, will remind prescribers that immediate-release opioids are also powerful drugs with important safety concerns,” said Doug Throckmorton, a deputy director in the FDA’s drug center.
Throckmorton said the agency’s 2013 labeling change focused on long-acting drugs like OxyContin because they represented a “disproportionate risk” to patients, since they contain larger opioid levels.
