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# FDA Denies St. Jude Codeine Use Petition
- URL: https://www.fdaweb.com/fda-denies-st-jude-codeine-use-petition/
- Published: 2023-08-15T12:00:00.000Z
- Updated: 2026-09-14T18:50:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155104

FDA has denied a St. Jude Children’s Research Hospital petition asking the agency to ease the current contradiction in codeine-containing analgesics to read that codeine should not be used to treat pain or cough in children under age 12 except for specified exceptions. The proposed language would say that “outside the setting of post-tonsillectomy or adenoidectomy, codeine may be prescribed for pain management in children younger than 12 years old who are known CYP2D6 normal metabolizers or CYP2D6 intermediate metabolizers based on pharmacogenetic testing that includes CYP2D6 copy number or gene duplication detection.”

The agency denial [letter](https://www.regulations.gov/document/FDA-2017-P-6918-0022?ref=fdaweb.com) says that in the past several years FDA has updated the labeling for codeine-containing prescription drugs several times regarding the risk of respiratory depression as a result of CYP2D6 polymorphism and the products are currently contraindicated in children under age 12.

The letter says the hospital gave six arguments supporting its request for exceptions and says FDA does not find any of the arguments persuasive.

The agency makes these points to support its denial:

- substantial risks to patients under age 12 remain, even with CYP2D6 testing;
- codeine’s role in the treatment of pediatric pain;
- prescriber convenience and patient access; and
- the existing contraindication continues to reflect agency views.

“FDA is sympathetic to the needs of pediatric patients, such as those with sickle cell disease, who experience painful conditions and need access to safe and effective treatments to manage their symptoms,” the letter concludes. “We also understand the frustration that prescribers and patients may experience in accessing important therapies. However, after careful consideration of your petition and the available evidence, the agency declines to amend the pediatric contraindication of codeine-containing analgesics as you have requested at this time.”