BETHESDA, MD 20 February 2013—FDA today told health care professionals to select an analgesic other than codeine to control the pain that children have after undergoing a tonsillectomy or adenoidectomy.
A statement of contraindication and a boxed warning specific to that patient population and clinical setting will become part of the labeling of codeine-containing products, according to the agency's safety announcement.
The announcement updates cautionary advice the agency had given last August. At the time, FDA had been particularly concerned about the use of codeine in children with obstructive sleep apnea syndrome and a drug-metabolizing enzyme, cytochrome P-450 (CYP) isoenzyme 2D6, that converts codeine to morphine at an ultrarapid rate. Three such children had died, and a fourth child had survived life-threatening respiratory depression.
Reports on four other children who underwent adenotonsillectomy, received codeine, and then died or had evidence of morphine overdose were found in a search of FDA's Adverse Event Reporting System database, the agency said.
Even though there are FDA-cleared tests for determining a patient's CYP2D6 genotype, the agency said it does not recommend routinely using these tests for children undergoing tonsillectomy or adenoidectomy.
FDA's safety announcement does not suggest alternatives to codeine for postoperative pain management in children who have undergone tonsillectomy or adenoidectomy.
A clinical practice guideline (PDF) from the American Academy of Otolaryngology—Head and Neck Surgery states that ibuprofen "can be used safely for pain control" in children after tonsillectomy.
The pain from tonsillectomy can often be managed with nonprescription analgesics and hydration, according to the panel that developed the guideline.
For that reason, the panel stated, the guideline does not recommend that physicians prescribe specific drugs.