The Food and Drug Administration (FDA) issued a request for public comment on the use of codeine for analgesia in children under 12 years of age and the use of cytochrome P450 2D6 (CYP2D6) testing in children under 12 years of age prior to treatment with codeine-containing analgesics.
The agency notes that codeine-containing prescription analgesic products are currently not recommended for children under 12 years of age and the agency is considering a request for regulatory action to amend this recommendation to provide use in children who are shown to be CYP2D6 normal metabolizers.
Specifically, the FDA seeks input from the healthcare community and the public on the following issues:
- Pain management in children under 12 years of age;
- Availability and clinical utility of CYP2D6 genotyping tests; and
- E-prescribing availability as a potential mitigation approach for opioid analgesic in urgent situations.
Additionally, the agency seeks answers to the questions that can be found on pages 13 through 16 of the request.
Comments are due August 28.