Stop Giving Codeine to Children, AAP Says

The American Academy of Pediatrics (AAP) is now advising against giving codeine to children.

Although codeine is widely used for pain relief, genetic variability in a patient’s drug metabolism causes varied efficacy results, according to a new clinical report from the AAP called “Codeine: Time to Say ‘No.’” Patients’ response to codeine depends on how quickly their body metabolizes the opioid, and patients who are fast metabolizers may exhibit strong reactions.

Children, especially those with sleep-disordered breathing, are at particular risk for opioid sensitivity. Because of this, standard doses of codeine can be fatal in these children. In fact, case reports have consistently linked the use of codeine to life-threatening or fatal respiratory depression in kids.

Despite these well-documented risks, as well as concerns expressed by health care groups that include the AAP, the FDA, and the World Health Organization, codeine is still available without a prescription in OTC cough formulas from outpatient pharmacies in 28 states and the District of Columbia, and it is still frequently prescribed to children as an analgesic and antitussive agent. One study cited in the AAP report revealed that more than 800,000 patients younger than 11 years were prescribed codeine between 2007 and 2011.

A review of data in the FDA’s Adverse Event Reporting System from 1965 to 2015 revealed 64 pediatric cases of codeine-related severe respiratory depression and 24 codeine-related deaths, 21 of which involved children younger than 12 years.

The AAP report uncovered 3 common factors among the codeine-related life-threatening and fatal events that occurred:

1. The majority of children were relatively young.

2. The children were put on a postoperative pain regimen of scheduled acetaminophen and codeine.

3. The children had undergone adenotonsillectomy for sleep-disordered breathing.

According to the AAP, the most effective way to reduce codeine-related adverse effects is to explore alternative medicines for pain relief. The clinical report mentions drugs such as oxycodone, tramadol, and tapentadol as potential avenues for treatment for pediatric patients. Nevertheless, determining a definitive alternative medication that is both safe and effective is difficult and requires further research.

As lead researcher Joseph D. Tobias, MD, FAAP, stated in a press release, “Effective pain management for children remains challenging because children’s bodies process drugs differently than adults do.”

Researchers have shifted their focus to the use of postoperative nonopioid analgesics, such as acetaminophen, and nonsteroidal anti-inflammatory drugs, such as ibuprofen, for acute pain relief in pediatric patients.

In 2015, the FDA recommended that the use of codeine-containing cough medicines should be contraindicated in children younger than 18 years. Final action on this recommendation is pending, and in the meantime, these medicines are still available at outpatient pharmacies for purchase.

According to the AAP, more restrictions on codeine prescribing in the pediatric population is necessary to reduce related risks. Further research on pain relief alternatives, coupled with provider and parental education on nonopioid treatments and the adverse effects of codeine, is key to establishing a safe treatment plan for children.