FDA revises label on opioid cold meds to limit pediatric use

The FDA this week announced that it’s mandating labeling changes to cut the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in kids under 18 years of age.

The agency wrote in a statement that the risks of these drugs outweigh their potential benefits for children. The medications will also receive an expanded Boxed Warning notifying users about the risks of abuse, addiction and death.

“Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children. We know that any exposure to opioid drugs can lead to future addiction. It’s become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don’t justify their use in this vulnerable population,” FDA Commissioner Dr. Scott Gottlieb said in prepared remarks.

“It’s critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone. At the same time we’re taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products.”

The safety labeling changes come from an extensive review of available data and testimony from experts given at meetings to study the pediatric use of cough and cold products that contain opioids, the FDA reported.

The move expands upon restrictions put in place last year when the FDA added a contraindication to the labels of prescription codeine products, alerting the public that codeine should not be used to treat pain or a cough in children younger than 12 years old.

At a meeting of the FDA’s Pediatric Advisory Committee, experts argued that although some pediatric cough symptoms require treatment, a cough due to a cold or respiratory infection usually doesn’t necessitate treatment.

“Today’s action is one example of the FDA’s work to further protect patients for whom the risks of opioid products outweigh the benefits,” the FDA wrote. “The agency continues its ongoing efforts to reduce the scope of the epidemic of opioid addiction on several fronts, including decreasing exposure and preventing new addiction, supporting treatment for those with opioid use disorder, fostering development of novel pain therapies and improving enforcement.”

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