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# Advisors Look at Pediatric OxyContin Safety Review
- URL: https://www.fdaweb.com/advisors-look-at-pediatric-oxycontin-safety-review/
- Published: 2019-08-20T12:00:00.000Z
- Updated: 2026-09-15T01:44:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144810

Members of the FDA Pediatric Advisory Committee and Risk Management Advisory Committee will meet 9/26-27 to discuss the required pediatric-focused safety review for OxyContin (oxycodone hydrochloride) extended-release tablets, as mandated by law. An FDA [notice](https://www.fda.gov/news-events/fda-brief/fda-brief-fda-hold-pediatric-advisory-committee-meeting-discuss-safety-review-certain-drugs?utm%5Fcampaign=082019%5FFIB%5FFDA%20announces%20next%20Pediatric%20Advisory%20Committee%20meeting&utm%5Fmedium=email&utm%5Fsource=Eloqua) says the committees also will discuss pediatric data considerations for opioid analgesics labeling and Pediatric Research Equity Act studies for opioids generally, using Endo’s Opana (oxymorphone) immediate-release as an example.

On the second day of the meeting, the committees will hear information on safety signals associated with montelukast (Merck’s Singulair).