The United States Food and Drug Administration has announced new required class-wide safety labeling changes for immediate-release (IR) opioid pain medication. Included in the changes is a new boxed warning about the serious risks of misuse, abuse, addiction, overdose, and death.
The updated indication clarifies that because of those risks, IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options, such as non-opioid analgesics or opioid combination products, are inadequate or not tolerated. Additionally, the dosing information provides clarity to previous instructions regarding patient monitoring and drug administration, including initial dosage, dosage changes during therapy, and a warning not to abruptly stop treatment in a physically dependent patient.
The FDA will also require a precaution that chronic maternal use of opioids during pregnancy can result in NOWS, neonatal opioid withdrawal syndrome, which can be life-threatening to the child if not recognized and treated immediately.
The FDA is also requiring an update of labeling for all opioids (ER/LA and IR products) to include safety information about potentially harmful drug interactions with other medicines that can result in a serious central nervous system condition, known as serotonin syndrome.
These changes come with a Safety Announcement by the FDA, where the FDA reminded prescribers and patients alike that opioids can lead to a rare, but serious, condition, where the adrenal glands do not produce adequate amounts of cortisol, which helps the body respond to stress. Additionally, included in the Safety Announcement is a statement that long-term use of opioids can be associated with decreased sex hormone levels and symptoms, such as reduced interest in sex, impotence, or even infertility. The Safety Announcement provides tips for patients and healthcare professionals for how to notice, evaluate, and possibly prevent the serious conditions warned of from happening.
These changes also follow changes the FDA made in 2013, where class-wide labeling changes were made for ER/LA opioid analgesics, including modifications to the products’ indications, limitations of use, and warnings, including boxed warnings to more effectively communicate to prescribers the risks associated with patients taking those drugs.
The FDA is continuing to review available scientific information about potentially serious outcomes related to interactions between benzodiazepines and opioids. Once the FDA has completed a review of all available scientific information, it will work to take “necessary actions to ensure prescribers and the public are informed of the risks involved with the use of these medications.”
FDA Commissioner Robert Califf, M.D., believes that these 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.”