FDA Issues New Labeling for Immediate-Release Opioids

The Food and Drug Administration announced a new labeling requirement Tuesday on instant release prescription opioids that warns of the dangers including addiction, overdose and death.

"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 Robert Califf, MD, told reporters at a Tuesday news briefing. The labels also carry a warning to expectant mothers about the risks of chronic immediate release opioid use. The warnings will be included on packages of all immediate-release opioid painkillers like morphine and Percocet (acetaminophen/oxycodone).

The FDA is also requiring several additional safety labeling changes across all prescription opioid products to include addition information about the risk the medications pose.

It is well known that IR opioids are prescribed more frequently than their ER/LA counterparts, refle cting a general assumption by physicians that there are somehow safer drugs. "When a patient gets his or her prescription filled, the bottle should have a notification indicating there is a black-box warning for the drug".

"This new indication, once finalized, will remind prescribers that immediate-release opioids are also powerful drugs with important safety concerns", Throckmorton said.

Those are given for pain severe enough to require daily, round-the-clock treatment and contain more drug per tablet than immediate-release tablets.

Short-acting opioids account for 90 percent of prescribed opioids, the FDA said. Almost 2 million Americans aged 12 or older either abused or were dependent on prescription opioids in 2014, according to the Centers for Disease Control and Prevention.

When taken with antidepressants and migraine medications, opioids can also cause a potentially life-threatening central nervous system condition known as serotonin syndrome, which oc curs when the body is overloaded with the brain chemical serotonin.

Califf added the new warnings will help, but the FDA can't regulate how doctors practice medicine. The FDA continues to increase the pressure on the prescription of opioids.

Markey said the FDA needs to do more to protect patients.

"We know that there is persistent abuse, addiction, overdose mortality and risk of NOWS associated with IR opioid products", said Douglas Throckmorton, M. D., deputy center director of regulatory programs, FDA's Center for Drug Evaluation and Research. "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".

The move is one of a series announced recently by the FDA as it seeks to tackle the problem of opioid overdose and death.

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Source: FDA Issues New Labeling for Immediate-Release Opioids