Painkiller will now carry a mandatory “black box” warning, the FDA said. The move is meant to slow the prescription drug epidemic surrounding addictions, abuse and death.
The U.S. Food and Drug Administration announced this week that popular immediate-release opioid painkillers and prescription drugs – such as oxycodone and fentanyl, as well as brands like Percocet and Vicodin – will now include a boxed warning on the package insert, signifying that the drug carries a significant risk of serious or even life-threatening adverse effects.
Reports Fox8 News on March 23: “Prescription opioid painkillers are divided into two main classes — extended release, which have more pain-killing opioid per dosage, and immediate release, which have less opioids, but need to be taken more frequently. Ninety percent of opioid prescriptions are for immediate-release painkillers, the FDA said.”
All immediate-release opioid painkillers will be rebranded with the strong warning labels. Over 175 brand name and generic drugs are included in the FDA release.
“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,” commented FDA Commissioner Dr. Robert Califf. “I can’t stress enough how critical it is for prescribers to have the most current information.”
Some lawmakers however are calling the FDA’s efforts too little and too late.
“Unfortunately, it has taken 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.
Adds Yahoo News: “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.”
According to the Centers for Disease Control and Prevention, since 1999 prescription death overdoses have quadrupled. The numbers parallel with an increase in the total amount of annual prescriptions written. More than 40 people die every day from an opioid overdose, and annually more die from overdoses than those who are killed in car accidents.
The Obama administration has asked for $1.1 billion dollars in funding from Congress in order to combat opioid addiction. This week, the White House issued letters to all state governors delineating steps that should be taken, in conjunction with the FDA warnings, to reduce both the over-prescribing of opioids and to outline addiction strategies.