Opioid Painkillers Will Have to Carry “Black Box” Warning: FDA

The Food and Drug Administration (FDA) announced Tuesday it will require immediate-release opioid painkillers to carry a “black box” warning about the risk of misuse, abuse, addiction, overdose and death, CNN reports.

Immediate-release opioids are usually intended for use every four to six hours, while extended-release opioids are generally intended to be taken once or twice a day. According to the FDA, 90 percent of opioid prescriptions are for immediate-release opioids. The FDA placed black-box warnings on extended-release opioids in 2013.

Bottles for immediate-release opioids will have a notification stating there is a black-box warning for the drug. Patients will need to go to the manufacturer’s website for details, the article notes. Pharmacists will be encouraged to give patients a medication guide explaining the risks of the drug.

“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,” FDA Commissioner Robert Califf, MD said in a news 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.”

The warning includes information about neonatal opioid withdrawal syndrome (NOWS), which can occur in a newborn exposed to opioids for a prolonged period during pregnancy. NOWS may be life-threatening if not recognized and properly treated, the warning states.

Earlier this month, the Centers for Disease Control and Prevention (CDC) issued guidelines that recommend primary care providers avoid prescribing opioid painkillers for patients with chronic pain. The risks from opioids greatly outweigh the benefits for most people, the CDC says.