The Food and Drug Administration (FDA) announced it is requiring class-wide safety labeling changes for all immediate-release (IR) opioid pain medicines. The changes include a new boxed warning about the serious risks of misuse, abuse, addiction, overdose, and death. This announcement comes on the heels of a recently published guideline from the Centers for Disease Control and Prevention (CDC) which offers recommendations to aid in prescribing opioid analgesics for patients with chronic pain.
Opioid painkillers, used to treat moderate to severe pain that may not respond well to other pain medicines, are divided into two categories: IR drugs, usually intended for dosing every 4–6 hours; and extended-release/long-acting (ER/LA) products, usually intended for dosing once- or twice-daily. Some opioids, such as methadone and buprenorphine, are also used as medication-assisted treatment (MAT) to treat opioid addiction in combination with behavioral therapy and counseling.
The labeling update clarifies that IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (eg, non-opioid analgesics or an opioid combination product) are inadequate or not tolerated. Also, the dosing information offers clearer steps on patient monitoring and drug administration, including initial dose, dose changes during therapy, and the avoidance of abruptly stopping treatment in a physically dependent patient. Similar labeling changes were initiated back in 2013 for ER/LA opioid analgesics; today’s announcement brings attention to the known risks associated with IR products.
The FDA is also requiring a precaution update that chronic maternal use of opioids during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening.
In its continued efforts to reassess the approach to opioid medicines, the FDA also issued a warning about major safety risks associated with all opioid pain medicines (both IR and ER/LA products). These risks include potentially harmful interactions with other drugs, problems with adrenal glands, and reduced levels of sex hormone.
The FDA is requiring modifications to all opioid drug labels to reflect the aforementioned safety risks. The Agency has investigated the following safety issues and has included recommendations for healthcare professionals: