Edited by David G. Fairchild, MD, MPH
All immediate-release prescription opioids must now carry a boxed warning about the risks for abuse, addiction, and misuse associated with the painkillers, the FDA announced on Tuesday.
The updates include the following:
- A warning that immediate-release opioids are intended to be taken every 4–6 hours and should only be used for severe pain that is not alleviated by alternative treatments
- Instructions on dosage, patient monitoring, and dosage changes during treatment
- A warning that treatment shouldn’t be stopped suddenly in patients who are physically dependent on the drugs
- A warning that pregnant women who chronically use opioids put their newborns at risk for neonatal opioid withdrawal syndrome
The FDA also added safety information to all prescription opioids, including those used to treat opioid addiction. They warned that opioids can interact with other drugs and lead to serotonin syndrome. Opioids can also put patients at risk for adrenal insufficiency and androgen deficiency.