OxyContin Repeat? US FDA Seeks To Avoid Fallout Over Butrans Pediatric Data
Advisory committees will discuss whether data from a 41-patient study should be added to Pediatric Use section of labeling for Purdue's buprenorphine product; agency's decision to convene expert panel even though a pediatric indication is not being considered grew out of criticism generated by approval of OxyContin for adolescents.
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Opponents say including data from a small pediatric trial of Purdue's buprenorphine patch could give the impression the study was more robust than it actually was, while supporters say labeling should reflect any available data that can inform pediatric prescribing.
US FDA advisory committee strongly recommends antitussives containing codeine or hydrocodone not be used by patients under age 18 years old, pointing to lack of modern evidence of benefit and known risks of respiratory depression and misuse. Expanding the contraindicated population could get some product sponsors off the hook for required pediatric studies.