FDA Panel Gives Unanimous Thumbs Up to OTC Naloxone

18 Feb 2023 • A key FDA advisory committee has voted to allow naloxone products to be sold for over-the-counter use. Every member of the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) agreed that the evidence of benefits from switching the drug to OTC status far outweighs the minimal risks. The American Medical Association (AMA) and the American Pharmacists Association support making naloxone more widely available in order to save lives.

Fatalities related to opioids have reached record highs in recent years.An estimated 80,205 people died from opioid overdose in 2021. To combat these rising rates the FDA has taken steps to help improve access to life-saving medication like naloxone.

A 2020 study took 810 adults and trained them to recognize the signs of opioid overdose as well as when and how to administer naloxone (through nasal spray or injection). The researchers found that almost 80% were able to understand and implement the training when needed.

Source: Medscape | Read full story

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