The FDA is taking steps to warn about the use of codeine to relieve children’s pain after surgery to remove their tonsils or adenoids. Deaths have occurred post-operatively in children who received codeine for pain relief following a tonsillectomy and/or adenoidectomy.
A new “Boxed Warning,” the FDA’s strongest warning, added to the drug label of codeine-containing products will warn about the risk of codeine in post-operative pain management in children following tonsillectomy and/or adenoidectomy (surgery to remove the tonsils and/or adenoids). A “Contraindication,” which is a formal means for the FDA to make a strong recommendation against use of a drug in certain patients, will restrict codeine from being used in this setting.
Codeine is an opioid pain reliever—a narcotic medication—used to treat mild to moderate pain. Children are often prescribed codeine for pain relief after surgery to remove their tonsils or adenoids to treat chronic tonsillitis or sleep apnea, a condition in which breathing problems make it hard for them to sleep soundly. However, some children have died after being given codeine in amounts that are within the recommended dose range.
Last fall, the FDA had announced 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. A search of FDA’s Adverse Event Reporting System (AERS) database from 1969 to May 1, 2012 identified 10 deaths and three overdoses associated with codeine. Many of these children were recovering from a surgery to remove their tonsils or adenoids.
According to the FDA, deaths have occurred in children with obstructive sleep apnea who took codeine for pain relief after tonsillectomy and/or adenoidectomy. These children had evidence of being ultra-rapid metabolizers of codeine, which is a genetic variation that results in their liver changing codeine into morphine more rapidly and completely than other people, reports the FDA. Ultra-rapid metabolizers are more likely to have higher-than-normal levels of morphine in their blood after taking codeine. From one to seven in every 100 people are ultra-rapid metabolizers, but they are more common among some ethnic groups. However, the only way to know if someone is an ultra-rapid metabolizer is to do a genetic test. Thus, the FDA’s new warning and 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.
According to the FDA, health care professionals should prescribe an alternate analgesic 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.
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. The FDA’s warning appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
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