FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Advisory Committees Vote for Co-Prescribing Labeling for Naloxone

Dec. 28, 2018
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Two FDA advisory committees voted 12-11 in favor of language on opioid labels that recommends co-prescribing of naloxone.

The joint Dec. 17-18 meeting of the Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management advisory committees also considered ways to increase the availability of naloxone. The public meeting included experts from academia, healthcare and the federal government, as well as presentations from drugmakers and the public.

Some supporters of labeling said it could help reach high-risk populations, noting that the CDC recommends co-prescribing of naloxone and opioids in high-risk cases. But others questioned the effectiveness of labeling versus other approaches.

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