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Codeine given to children after tonsil/adenoid removal can be fatal

Robin Wulffson MD's picture
tonsillectomy, adenoidectomy, codeine, fatalities, surgical risk

A tonsillectomy and/or adenoidectomy is a not uncommon surgical procedure for children with recurring problems with those glands. Although all surgery is associated with some risk, many would deem to be these procedures of relatively low risk. However, the procedure can result in death—not from the surgical procedure itself—but from pain medication given afterwards. On February 20, the Food and Drug Administration (FDA) issued a strong warning regarding the administration of codeine to certain children following a tonsillectomy and/or adenoidectomy.

In its report, the FDA noted that it was updating the public about new actions being taken to address a known safety concern with codeine use in certain children after tonsillectomy and/or adenoidectomy. The agency noted that deaths have occurred post-operatively in children with obstructive sleep apnea who received codeine for pain relief following the procedure. Codeine is converted to morphine by the liver. Apparently, these children had evidence of being ultra-rapid metabolizers of codeine, which is an inherited (genetic) ability that causes the liver to convert codeine into life-threatening or fatal amounts of morphine in the body.

The FDA notes that a new Boxed Warning, its strongest warning, will be added to the drug label of codeine-containing products about the risk of codeine in post-operative pain management in children following tonsillectomy and/or adenoidectomy. A Contraindication, which is a formal means for FDA to make a strong recommendation against use of a drug in certain patients, will be added to restrict codeine from being used in this setting. The Warnings/Precautions, Pediatric Use, and Patient Counseling Information sections of the drug label will also be updated.

Last August, the FDA announced that it was reviewing the safety of codeine due to cases of deaths and serious adverse events in children who took the drug after a tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine. The agency conducted a comprehensive safety review to identify additional cases of overdose or death in children taking codeine and to determine if these adverse events occurred in any other treatment settings. Many of the cases of serious adverse events or death occurred in children with obstructive sleep apnea who received codeine after a tonsillectomy and/or adenoidectomy. Since these children already had underlying breathing problems, they may have been particularly sensitive to the breathing difficulties that can result when codeine is converted in the body to high levels of morphine. The FDA cautions, however, that the contraindication applies to all children undergoing tonsillectomy and/or adenoidectomy because it is not easy to determine which children might be ultra-rapid metabolizers of codeine.

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The FDA recommends that healthcare professionals should prescribe an alternate analgesic (pain killer) for post-operative pain control in children who are undergoing tonsillectomy and/or adenoidectomy. Codeine should not be used for pain in children following these procedures.
For management of other types of pain in children, codeine should only be used if the benefits are anticipated to outweigh the risks. The FDA recommends that parents and caregivers who observe unusual sleepiness, confusion, or difficult or noisy breathing in their child should stop giving codeine and seek medical attention immediately, as these are signs of overdose.

Take home message:
I grew up in an era when a tonsillectomy and/or adenoidectomy was much more commonly performed. The indications are much stricter today; however, some children qualify under present guidelines. The drug of choice following the procedure was Aspergum (chewing gum containing aspirin), which soothed the throat and provided pain relief. Codeine was not administered. Thus, the problem is related to the more liberal use of pain killers in today’s times.

The tonsils and adenoids help protect against infections; however, children with large glands may have frequent throats and ear infections.

You and your child’s doctor may consider a tonsillectomy if:

  • Your child has frequent infections (seven or more times in one year, or five or more times over two years).
  • Your child misses school frequently.
  • Your child has trouble breathing.
  • Your child has abscesses or growths on their tonsils.

An adenoidectomy may be recommended when:

  • Enlarged adenoids are blocking your child’s airway. This may be suspected if your child: snores a lot; has trouble breathing through their nose (nasal obstruction); has episodes of not breathing during sleep (sleep apnea).
  • Your child has chronic ear infections that: interfere with school attendance; persist even with antibiotic treatment; recur five or more times in a year; recur three or more times a year during a two-year period.
  • An adenoidectomy may be recommended if your child has chronic or repeated bouts of tonsillitis

Reference: FDA