FDA Advisory Panel Splits on Pediatric Labeling for Opioid Patch

September 19, 2017

Two FDA advisory committees grappled with the proposed addition of information from a pediatric study to labels for Purdue Pharma’s opioid patch Butrans (buprenorphine), without coming to a clear consensus.

Purdue was not seeking to add a pediatric indication to Butrans — the question concerned whether to include study information in the pediatric use section of the label.

Participants in the Sept. 14 joint meeting of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee were concerned that the number of study participants was too small to support firm recommendations on pediatric use, committee member Kevin Zacharoff, an anesthesiologist and clinical instructor at the State University of New York at Stony Brook, told FDAnews.

Some members supported the label inclusion, on the belief that any information about pediatric use could prove valuable. Other members worried that the proposed labeling would give prescribers unwarranted confidence in the medication, and would suggest it was indicated for children, Zacharoff said.

The FDA did not ask the advisory committee to vote on the question.

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