FDA Approves Narcan for Over-The-Counter Sales

On March 29 2023, a popular post to Reddit’s r/UpliftingNews and a viral tweet both reported that the United States Food and Drug Administration (FDA) had approved over-the-counter sales of Narcan:

In the tweet, medical toxicology expert Ryan Marino stated that the FDA had approved Narcan nasal spray for over-the-counter, nonprescription, use, adding: “This is huge. Naloxone saves lives.”

What is Narcan?

Google Trends detected “Breakout” levels of search interest for “What is Narcan?” on March 29 2023, likely due to claims the FDA approved it for over-the-counter sale.

An October 2022 University of Wisconsin-Madison Police Department resource about Narcan began with information about the prevalence of opioid overdose deaths in 2019:

In 2019, almost 50,000 people in the US died as a result of opioid overdose; this number includes events involving prescription pain medications, heroin, and synthetic opioids like fentanyl. The CDC estimates the annual economic burden of prescription opioid misuse at $ 78.5 billion.

A section labeled “What is naloxone and how does it work?” provided information about naloxone (Narcan), with respect to its use and administration:

Naloxone is an opioid antagonist. Instead of counterbalancing symptoms like Epinephrine (EpiPen) to overcome the effects of an extreme allergic reaction, naloxone blocks the brain’s uptake of opioids by replacing them. Think of your brain cells like a toddler’s shape sorter toy — the one with the different shaped holes and blocks. Naloxone comes along and replaces the opioid. It can boot it out or fill the hole before the heroin comes along.

Naloxone does not treat overdoses of non-opioid medications, and it does not have an effect on someone who has not taken opioids.

Another section addressed questions about whether medical intervention was required after naloxone was administered, in the context of getting a friend “in trouble.” It mentioned an “amnesty” program, adding:

YES — you do [have to call 911]. Naloxone is fast acting and temporary — whereas opioids can be very long lasting. The overdose victim can often succumb to the opioids again as soon as the naloxone wears off. They can slip back into unconsciousness and stop breathing all over again! That’s why it’s so important to call 911 if you administered naloxone to anyone.

Naloxone or Narcan Over the Counter

Both links (on Reddit and Twitter) pointed to additional information about the FDA’s Narcan decision.

Marino linked to a lengthy March 29 2023 FDA press release, “FDA Approves First Over-the-Counter Naloxone Nasal Spray.” In the first few paragraphs, the agency announced that Narcan spray was newly approved for sales without a prescription:

Today [March 29 2023], the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Today’s action paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.

The timeline for availability and price of this OTC product is determined by the manufacturer. The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only.

Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl.

The FDA’s press release noted that there were more than 101,750 fatal overdoses in the year-long period between October 2021 and October 2022, primarily attributed to opioid abuse. It formed a sober contrast to the October 2022 resource quoted above, which measured 50,000 deaths related to opioid overdoses in 2019.

Summary

On March 29 2023, social media posts indicated that the FDA approved naloxone (Narcan) for over-the-counter sale without a prescription. On that date, the FDA issued a press release confirming the decision, adding that the authorization was one of “a series of measures to help facilitate access to naloxone products” by the agency.