FDA Orders Black Box Warnings on Immediate-Release Prescription Opioids

FDA Orders Black Box Warnings on Immediate-Release Prescription OpioidsThe Food and Drug Administration (“FDA”) has announced that it will require manufacturers of immediate-release prescription opioid pain medications to carry black box warnings about the risk of addiction, abuse, overdose and death from these medications.

The warnings will apply to more than 200 immediate-release opioid products, including hydrocodone, oxycodone, morphine and other widely prescribed pain killers. According to the Centers for Disease Control and Prevention, there were 28,647 deaths associated with opioid overdose in the U.S. in 2014.

“Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,” said Robert Califf, M.D., FDA commissioner. “Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic.”

The FDA has also mandated a warning that the chronic use of opioids by pregnant women can result in Neonatal Opioid Withdrawal Syndrome, which is potentially life-threatening to newborns if not treated.

The FDA ordered black box warnings to extended-release opioids in 2013, and has been criticized for waiting too long to address the risks associated with immediate-release opioids.

According to the FDA, the warnings will emphasize to physicians that opioids should only be prescribed as a last resort for severe pain. There will also be updated dosing information with clearer instructions to physicians on how to administer the drugs and monitor patients.

The FDA warnings dovetail with new national guidelines for physicians on the use of opioids issued by the Centers for Disease Control and Prevention on March 15, 2016. Those guidelines urge physicians to be more cautious and consider alternatives before prescribing the highly addictive painkillers.

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