New FDA Labeling Changes to Require “Black Box Warning” on Immediate Release Opioid Pain Medications

In an effort to combat what it calls “epidemic levels of opioid addiction and overdose”, the U.S. Food and Drug Administration (FDA) announced that it will require class-wide safety labeling changes for immediate release opioid pain medications, including a new “black box warning” informing patients and prescribers of the serious risks of misuse, abuse, addiction, overdose and death. In addition, the FDA will also require several safety labeling changes across all prescription opioid products to include additional warnings addressing the risks of opioids.

Opioid analgesics, including prescription oxycodone, hydrocodone and morphine, are typically divided into two main categories. Extended release/long acting (ER/LA), typically carry a larger load of medicine, are intended to be taken once or twice a day and were the subject of FDA mandated labeling changes in 2013. Immediate release (IR) opioid products, the subject of the most recent mandate, are intended for use every four to six hours. The new labeling changes for IR opioid products clarify that due to the risks associated with use, IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options are inadequate or not tolerated. The updated black box warnings on IR opioids will also include precautions that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life threatening if not recognized and treated.

The FDA will also require updated labeling on all opioids (IR and ER/LA) to include safety information about potentially harmful drug interactions with other medications which can cause a serious central nervous system condition called serotonin syndrome, as well as information about opioid effects on the endocrine system (adrenal insufficiency) and decreased sex hormone levels (androgen deficiency). This FDA action is part of a larger initiative by the U.S. Department of Health and Human Services to address opioid misuse, addiction and overdose.

While the evidence of the dangers of opioid addiction and misuse have been known for some time, the black box warning may lead to an initial surge in litigation from individuals who allege they were harmed by the drug prior to the back box warning. The typical argument plaintiffs will make is that the manufacturers knew, or should have known, of the risks but failed to update their warning accordance with the prevailing science. There are preemption issues that will need to be addressed in any cases involving opioids and an alleged failure to warn. In these cases, the black box warning may be used as evidence to bolster allegations that drug manufacturers knew of the addictive properties, and dangers associated with misuse or abuse of opioid products, yet failed to take sufficient steps to warn learned intermediaries and/or consumers. As such, drug manufacturers, health care providers and their legal counsel need to remain keenly aware of the ever changing regulatory landscape, and continue to anticipate how these changes may affect their liability interests in the future, including an assessment of whether there is implied preemption.

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