FDA Enhances Label Warnings for Immediate-Release Opioids

March 22, 2016
BioPharm International Editors

The agency announced enhanced warnings for immediate-release opioids to inform prescribers and patients of risks related to use.

On March 22, 2016, FDA announced that it is requiring class-wide safety labeling changes for immediate-release (IR) opioids. The requirement is a part of the agency’s effort to educate prescribers and patients about the potential risks associated with the use of opioid drugs.

The changes include a new boxed warning about the risks of misuse, abuse, addiction, overdose, and death. FDA is requiring the warning to include a precaution that chronic use of IR opioid analgesics during pregnancy can result in neonatal opioid withdrawal syndrome. The agency is also requiring updated labeling for all opioids to include warnings about drug interactions that can lead to serotonin syndrome, a serious central nervous system condition. In a press release, FDA stated, “Updated labeling will also include information about opioid effects on the endocrine system, including a rare but serious disorder of the adrenal glands (called adrenal insufficiency) and decreased sex hormone levels (androgen deficiency). 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).”

“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 FDA Commissioner Robert Califf, MD, in a press release. “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.”

Source: FDA