a box for Narcan spray sits on top of a leaflet reading "Overdose Rescue Kit." There are two units of Narcan on top of the leaflet.

FDA Approves Over-the-Counter Use of Narcan, a Treatment Used to Prevent Opioid Overdose Fatalities

Overdose deaths from drugs and alcohol rose in workplaces from 2020 to 2021.

The U.S. Food and Drug Administration (FDA) has approved the over-the-counter (OTC) use of Narcan nasal spray, a brand name for naloxone. When administered, naloxone can reverse an opioid overdose, saving a person’s life.

In 2020, 68,630 people died from an overdose of opioids—which include substances like heroin, fentanyl, oxycodone and codeine—in the U.S., according to the National Institute on Drug Abuse. In 2021, this number increased to 80,411 deaths.

When honing in on overdose-related deaths in the workplace, we see a similar increase. Per the Bureau of Labor Statistics (BLS), in 2020, 388 peopled died in the workplace from an unintentional overdose of nonmedical use of drugs or alcohol, and in 2021, it jumped to 464 fatalities. Industries that saw the highest number of fatalities from this were the trade, transportation and utilities industry at 114 fatalities and the construction industry at 96 fatalities.

The FDA’s approval of Narcan use (four milligrams) without a prescription opens doors for the access to and use of this medication, leading to fewer lives lost, including employees at work. The approval was announced on March 29, 2023.

According to a news release, the FDA is unsure of when Narcan will be available OTC as “the timeline for availability and price of this OTC product is determined by the manufacturer.”

Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in the news release, “The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status. Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.”

This is the first naloxone product approved by the FDA for OTC use, the agency said.

Want to learn more about naloxone use in the workplace? Read these resources below:

Photo credit: Bob LoCicero / Shutterstock.com

About the Author

Alex Saurman is the Content Editor for Occupational Health & Safety.


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