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FDA Likely to Approve Over-Counter Sales of Narcan

Two committees that advise the Food and Drug Administration unanimously voted to approve over-the-counter use of Narcan, the overdose-reversing nasal spray, making it very likely that the vote will be approved, the New York Times reports. It could potentially become available in vending machines, schools, convenience shops, big box stores and supermarkets by summer. As the overdose crisis worsened in recent years, the use of Narcan has become commonplace, but the millions of doses have been administered largely by outreach workers, health care providers and emergency responders. For people who use drugs as well as their friends and relatives, ready access to the prescription medication has been elusive. Many public health experts believe that if more people were to have the spray readily available at home, or in their pockets or knapsacks, many fatalities could be averted.


The Biden administration has made expanding access to the medicine a priority in its efforts to combat the overdose crisis, which reached a record 107,000 deaths in 2021. The rising fatalities include people addicted to opioids as well as those who illegally purchased prescription medications like Xanax or Percocet that had been tainted with the deadly synthetic opioid fentanyl. Experts at Wednesday’s daylong hearing noted that even stimulants like methamphetamine and cocaine are being mixed with fentanyl, leading to even greater numbers of accidental overdoses. In recommending that the spray become as easily available as ibuprofen, the 19 voting panelists determined that naloxone (Narcan's generic name), which was approved as an overdose-reversal injection in 1971, is abundantly safe and effective even in infants, with almost no potential for misuse or abuse. And, the panels concluded, naloxone does not require medical training to use. Side effects, typically symptoms associated with withdrawal, were relatively negligible compared with the medicine’s far greater lifesaving benefit, panel members said. Naloxone, which comes in a nasal spray, a vial and preloaded syringes, is believed to have saved hundreds of thousands of lives.

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