| opioid therapy

Pediatric Pain Management and Codeine

Physicians and Stakeholders Input Requested

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on specific questions pertaining to 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. These questions are posed in section II.

DATES: Submit either electronic or written comments by August 28, 2020.

FDA is soliciting information and comment from stakeholders regarding the issues described in this document. In addition to any other aspects of these issues that stakeholders may care to comment upon, FDA is interested in answers to the following questions in particular:

Topic 1: Pain Management in Children Under 12 Years of Age (for Prescribers and Other Stakeholders, as Appropriate)

1. What factors do you consider in choosing to prescribe an opioid analgesic for children under 12 years of age who require treatment for recurrent episodes of acute pain (e.g., severity of pain, lack of response to other analgesics, or the specific disease, such as children with sickle cell disease-related pain crises)?

2. Which pediatric populations, other than children with sickle cell disease, typically use an opioid analgesic for recurrent episodes of acute pain?

3. What role, if any, do you see for codeine/acetaminophen combination drug products in the treatment of children under 12 years of age with recurrent episodes of acute pain?


Access the full notice.


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