FDA Warns of Risk of Death From Codeine in Children Following Surgery

The FDA has issued a Drug Safety Communication concerning three children who died and one child who contracted a life-threatening case of respiratory depression after taking the pain reliever codeine following a tonsillectomy or adenoidectomy.

The surgeries were performed to treat obstructive sleep apnea syndrome, a condition that results in repeated episodes of complete or partial blockage of the upper airway. The children received doses of codeine within the typical dose range.

Healthcare professionals and parents should be aware of the risks of using codeine in children who have had their tonsils and/or adenoids removed due to problems with sleep apnea syndrome. When prescribing codeine-containing drugs, healthcare providers should use the lowest effective dose for the shortest time on an as-needed basis.

If parents or caregivers notice signs of overdose in a child, such as unusual sleepiness, difficulty being aroused or awakened, confusion, or noisy and difficult breathing, they should stop administering codeine and seek medical attention immediately.

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