"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," FDA Commissioner Dr. Scott Gottlieb said in an announcement on the FDA's website.
"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," he said. "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."
Though the FDA's warning substantially decreased codeine prescriptions among children after tonsillectomies or adenoidectomies, about one in 20 kids undergoing those surgeries still was prescribed codeine in December 2015, despite safety concerns and efficacy issues, according to a study published in the journal Pediatrics in November.
The study included data on 362,992 privately insured children who had undergone those surgical procedures.
The FDA also recommended against the use of these medications by women who are breastfeeding.
Gottlieb said in a statement in August that the FDA would be meeting with the Pediatric Advisory Committee to further evaluate the use of prescription opioid products containing hydrocodone or codeine to treat cough in children.
Now, the FDA's latest action to revise safety labeling on some prescription cough and cold products expands the pediatric restrictions that were previously in place.
Parents whose children are currently prescribed a cough and cold medicine containing codeine or hydrocodone are encouraged to talk to their child's health care professional about other treatment options, the FDA advised.
The agencyalso noted that some products sold over-the-counter in a few states may contain codeine or may not be appropriate for young children, so it's important to check the labels.