No Consensus Among FDA Officials on Naloxone Dose Increase

A group of 28 FDA officials could not reach an agreement on whether to increase the dose of the injectable naloxone or leave it at 0.4 mg.

Fifteen of the panelists voted to increase the dose, while 13 voted to keep the dosage the same during a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM).

Panelists who voted in favor of raising the dose did so due to the increasing use of powerful opioids such as fentanyl and carfentanil, which could require more doses or higher doses to revive patients.