Life-Saving Naloxone Approved for Over-the-Counter Use by FDA

The FDA's recent approval allows naloxone to be sold on store shelves anywhere.

click to enlarge The FDA's recent approval allows naloxone to be sold on store shelves. - Photo: Provided by Harm Reduction Ohio
Photo: Provided by Harm Reduction Ohio
The FDA's recent approval allows naloxone to be sold on store shelves.

A life-saving medication that rapidly reverses the effects of opioid overdoses will soon become available over the counter.

The federal Food and Drug Administration (FDA) approved the nasal spray naloxone (brand name Narcan) for over-the-counter use on March 29.

The FDA's approval allows naloxone to be sold on store shelves anywhere, as well as online, without having to speak to a pharmacist.

“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Naloxone, which can reverse an opioid overdose, has been available at most Ohio pharmacies for years, but previously required a pharmacist to dispense the nasal spray, limiting the availability of the life-saving drug to pharmacy hours.

Mail-order naloxone from harm reduction groups has been available without prescription, but organizations have had to operate under a prescriber-authorized protocol in order to distribute naloxone to advocates and at-risk users.

It’s not clear when naloxone will start appearing on store shelves in Ohio.

When administered correctly during an overdose, naloxone blocks the effects of opioids on the brain and quickly restores breathing. Naloxone is harmless, even if given to a person who is not experiencing an overdose, but it does not reverse overdoses that are caused by non-opioid drugs, like cocaine, benzodiazepines (e.g. Xanax, Klonopin and Valium), methamphetamines or alcohol.

Another naloxone-resistant drug that has swept Ohio in recent months is xylazine, which is most commonly found cut into fentanyl, but has also appeared in party drugs like cocaine.

Xylazine is a central nervous system depressant that can cause drowsiness, amnesia and slowed breathing, heart rate and blood pressure and can cause scaly wounds on all parts of the body, known as eschar. The effect has given xylazine the “zombie drug” nickname, and coroners in various corners of the country are starting to see more people killed by the drug.

Harm Reduction Ohio, an organization that equips people to fight overdose deaths and aggregates overdose data, recently forecasted that overdose deaths might actually be on a slight decline in the state overall.

According to a March 30 report from Harm Reduction Ohio, overdose deaths declined about 5% in 2022 versus 2021. The final overdose death count for 2022 won’t be available until late 2023, but 4,746 overdose deaths have been confirmed and reported so far in Ohio for 2022, a 5.1% decline from the 5,003 reported in 2021.

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