FDA splits on naloxone dose

A joint meeting of FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee failed to produce consensus on the minimum dose of naloxone needed to reverse the effects of opioid overdose.

A joint meeting of FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee failed to produce consensus on the minimum dose of naloxone needed to reverse the effects of opioid overdose. A total of 13 members agreed that the current injectable standard of 0.4 mg is effective and should remain in place—many of them expressing concern that raising it could send patients into withdrawal—but 15 argued for a higher minimum dose based on the trend toward abuse of ever more powerful opioids. Voters on both sides agreed, however, that evidence to make an informed decision was lacking. While the issue of minimum dose remains unresolved, the panelists were somewhat more definitive in a vote on whether to have the same minimum dose for children and adults. In that case, the count was 21-7 to keep those numbers consistent.

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