In an announcement Tuesday, the FDA announced the new label changes including a boxed warning about the risks of abuse, and additional information about the risk of using immediate-release opioid pain medications such as oxycodone, hydrocodone and morphine.
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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. Those are given for pain severe enough to require daily, round-the-clock treatment and contain more drug per tablet than immediate-release tablets.
Similar changes to the labeling of extended-release/long-acting (ER/LA) opioid analgesics were required by the FDA in 2013.
Those medications are among the most commonly prescribed drugs in the USA – accounting for 90 per cent of all opioid painkillers.
Specifically, the requirements affect 87 brand-name drugs and 141 generics, Sabrina Tavernese reports for the New York Times. The warnings will appear on immediate-release painkillers, which are taken every four to six hours.
The FDA wants to warn doctors and patients about the dangers of the drugs while ensuring they remain available for patients who need them to alleviate pain.
Califf, whose nomination was briefly held up by a senator who insisted the FDA change the way it approves opioids, responded with his 8-point plan. “These labeling changes will also make it clear that these negative outcomes can occur whether a patient is taking an opioid to treat pain or if the product is being used for medication-assisted treatment (MAT)”.
Markey said the FDA needs to do more to protect patients.
The CDC’s guidelines recommended doctors should only ever prescribe opioids after considering physical therapy, over-the-counter medications, counseling and other chronic pain treatment methods.
“We know that there is persistent abuse, addiction, overdose mortality with IR opioid products”, said Dr. Throckmorton.
Deaths linked to misuse and abuse of prescription opioids climbed to 19,000 past year, the highest figure on record, according to the Centers for Disease Control and Prevention. She said together they cause more than a third of unintentional prescription opioid overdose deaths.
Critics of the FDA, including Physicians for Responsible Opioid Prescribing, called on the agency to add such warnings years ago.
The FDA are rolling up their sleeves in the fight against opioid abuse. The FDA said it was reviewing such a warning.
The Obama administration has asked Congress to provide $1.1 billion to combat opioid addiction. 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 serotonin syndrome, the agency said.
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“The broad set of actions announced today is reflective of the FDA’s efforts to improve informed prescribing of opioids across the board”, said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in the press release.
