Nonprescription drug products for pain (analgesics) and fever (antipyretics) for children ages 2 to less than 12 are primarily limited to those containing acetaminophen or a nonsteroidal anti-inflammatory drugs (NSAIDs) and indicated for the temporary relief of minor aches and pains due to the common cold, sore throat, flu, headache, toothache, and/or fever reduction. Though new acetaminophen and NSAID-containing products may provide additional treatment options, there continues to be confusion and ambiguity regarding the extent to which expanded treatment options might lead to consumer confusion and whether the pediatric population would actually benefit.
On November 15, 2024, FDA will be holding a public workshop on Nonprescription Analgesic/Antipyretic Drug Development in Children 2 to Less Than 12 Years of Age that will explore the following topics:
- The necessity for developing new nonprescription analgesics/antipyretics containing acetaminophen or NSAIDs, either alone or in combination, to reduce pain and fever
- Drug characteristics that represent a therapeutic benefit over current treatment options
- The pediatric subpopulations that would benefit from these new nonprescription drugs for the already established labeled uses
- The potential unintended consequences (e.g., consumer confusion) of introducing more products containing similar ingredients for the same indication in this pediatric population
Registration for the workshop is required whether you will be attending in-person at the FDA White Oak Campus (Building 31, the Great Room) or virtually.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
