“A joint FDA advisory panel was split on whether the injectable 0.4-mg dose of naloxone should remain the current standard by which products containing the opioid overdose reversal drug should be measured — though they agreed that a lack of data made their decision more challenging.
Slightly more panelists voted to increase the minimum acceptable dose rather than maintain it (15-to-13) during the joint meeting of the Anasthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM).
A vote on whether to have the same minimum dose standard for adults and children was a bit more straightforward, at 21-to-7 in favor of keeping those figures consistent — but some said that dose should be higher, while others said it was fine as-is.
Panelists who voted to raise the minimum dose largely cited the increasing use of more potent opioids like fentanyl and, more recently, carfentantil, which might require more doses or higher doses of naloxone to revive patients.”
Source: MedPageToday.com – October 6, 2016