One in 20 children are still prescribed codeine for pain relief after having surgery on their tonsils and adenoids despite strong restrictions from the US Food and Drug Administration (FDA) against it, according to a new report published in Pediatrics.1
Researchers say these prescribing practices are “unacceptable” because there are too many dangers associated with codeine use in children, and so many alternatives to pain relief.
“Despite a 2013 FDA black box warning—the strongest warning the FDA can issue—there is still residual inappropriate codeine prescribing for children undergoing removal of the tonsils and/or adenoids,” says Kao-Ping Chua, MD, a pediatrician at the University of Michigan C.S. Mott Children’s Hospital and lead author of the study. “This is unacceptable, because codeine has potentially catastrophic ramifications for child health in this scenario and because there are safer and more effective alternatives to manage postsurgical pain.”
History of warnings against codeine
The FDA issued a black box warning in 2013 cautioning against the use of codeine to relieve pain after tonsillectomy or adenoidectomy in children. Additional warnings were issued in 2015 about the risk of respiratory problems related to the use of both codeine and tramadol in children, the FDA says. Some children metabolize these medications at a much faster rate, which can result in dangerously high levels in their bodies. At the time, the FDA promised to continue its review of codeine use in children.
As a result of this continued safety review, the FDA issued new restrictions to codeine, as well as tramadol, in April 2017, limiting use of the medications to adults only.2
“These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children [aged] younger than 12 years, and should not be used in these children,” the FDA wrote in the April 2017 notice. “These medicines should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are FDA approved only for use in adults. We are also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.”
The FDA required labeling changes as a result of the new restriction, labeling codeine use as a contraindication in children’s pain and cough medications, and after surgery.
AAP supports codeine restrictions
The American Academy of Pediatrics (AAP) affirmed the FDA’s restrictions in September 2016, recommending that codeine not be used in pediatric populations.3 The AAP based its recommendation on the fact that codeine in children can be either ineffective for pain relief or too effective resulting in respiratory depression. At the time of the recommendation, the AAP noted 64 cases of respiratory depression related to codeine-containing medications and 24 codeine-related deaths in children aged younger than 12 years between 1965 and 2015. Other countries and the World Health Organization also have cautioned against using codeine-containing medications in children.
Chua’s study1 shows that after the FDA’s initial restriction in 2013, codeine prescribing after tonsil and adenoid surgeries decreased 13 percentage points. Regardless of the improvement, however, the study also showed that 5% of the 363,000 children studied still received codeine prescriptions after these procedures in spite of the warnings in both 2013 and 2015. Thirty-one percent of patients in the study group were given at least 1 prescription for codeine within 7 days of surgery, and 32% of children received at least 1 prescription for an alternative opioid, according to the report.
Additionally, medications containing codeine made up about 47% of prescriptions filled at the start of the study period in 2010, and the remainder consisted of medications containing either hydrocodone or oxycodone. By the end of the study period, medications containing codeine made up 9% of prescriptions filled, and most of the rest of the prescriptions were for hydrocodone, the study noted.
Prescribing practices must change
The researchers acknowledge the decrease in prescribing codeine for children, but say it’s not enough.
“I hope this message also reminds pediatric providers of the dangers of codeine for children in general,” Chua says, referencing the AAP’s support of the FDA restrictions. “I agree with the AAP that codeine prescribing in children for any reason should be a zero event. Not only is codeine potentially unsafe, but it is also potentially ineffective due to unpredictable genetic variability in the way that children metabolize codeine to morphine.”
First-line therapy for children undergoing a tonsillectomy or adenoidectomy should be around-the-clock acetaminophen, Chua says. Ibuprofen may also be used as an alternative, he adds, and children in more severe pain may receive oxycodone or hydrocodone. These are effective in managing pain, but also come with some concerns, he notes. There is a difference in how opioids are metabolized in children versus adults, and there is a potential for abuse with opioids, he cautions.
Chua says he hopes his study will help motivate clinicians to examine their prescribing practices when it comes to using codeine in children.
“I hope that pediatric quality improvement leaders will make targeted efforts to eliminate inappropriate codeine prescribing to children undergoing tonsillectomy and/or adenoidectomy,” Chua says. “I also hope that this report raises awareness among parents that there are safer and more effective alternatives to codeine to control pain after tonsillectomy and/or adenoidectomy, including over-the-counter agents and alternative noncodeine opioids.”
1. Chua KP, Shrime MG, Conti RM. Effect of FDA investigation on opioid prescribing to children after tonsillectomy/adenoidectomy. Pediatrics. 2017;140(6):e20171765.
2. US Food and Drug Administration. FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. Published April 20, 2017. Accessed January 2, 2018.
3. Tobias JD, Green TP, Coté CJ; Section on Anesthesiology and Pain Medicine, Committee on Drugs. Codeine: time to say “no.” Pediatrics. 2016;138(4):e20162396. Epub September 19, 2016.