FDA Announces Safety Labeling Changes for Immediate-Release Opioid Medications

The Food and Drug Administration (FDA) announced yesterday that it has issued class-wide safety labeling changes for immediate-release (IR) opioid pain medications in an ongoing effort to educate prescribers and patients about the potential risks associated with opioid use. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose, and death from IR opioids, which are intended for use every four to six hours.

“IRs [opioids] are the most frequently prescribed type of opioid medication,” said Douglas Throckmorton, M.D., deputy director of regulatory programs at the FDA’s Center for Drug Evaluation and Research, during a conference call. Until now, very few IR opioids have received labeled warnings, he explained. (In 2013, the FDA required class-wide labeling changes for extended-release and long-acting [ER/LA] opioid analgesics—intended to be taken once or twice a day—which included modifications to the products’ indications, limitations of use, and warnings.)

As part of the boxed warning on IR opioids, the FDA will now require a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome in offspring, which may be life-threatening if not recognized and treated properly.

In addition, the FDA is requiring updated labeling for all opioids—both IR and ER/LA products—to include safety information about potentially harmful drug interactions with antidepressants and medicines intended to treat migraines that can result in a serious central nervous system condition called serotonin syndrome.

Modified labeling for all opioids will also include information about opioid effects on the endocrine system, including a rare but serious disorder of the adrenal glands (called adrenal insufficiency) as well as decreased sex hormone levels (androgen deficiency). The labeling changes will 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 for opioid use disorder.

The FDA is currently reviewing available scientific information about potentially serious outcomes related to interactions between benzodiazepines and opioids. Once this review is completed, the FDA will take necessary actions to ensure prescribers and the public are informed of the risks involved with the use of these medications.

To read more about recent FDA efforts to combat the prescription opioid epidemic, see the Psychiatric News article “FDA Officials Propose Strategy for Tackling Prescription Opioid Epidemic.”

(Image Courtesy of the Food and Drug Administration)