FDA Says Certain Naloxone Products May Be Safe, Effective for Over-the-Counter Use

The move could increase accessibility of the drug, and combat the opioid overdose crisis.

pharmacist holding naloxone/narcan nasal spray box

Chicago Tribune/Getty Images

  • The FDA released a preliminary assessment saying that some forms of naloxone, a drug used to reverse opioid overdoses, could be safe for over-the-counter use in the future.
  • Naloxone is currently authorized for prescription use only, though all states have access laws that allow people to get the medication from a pharmacy without an individual prescription.
  • Selling naloxone over-the-counter would likely remove accessibility barriers and make it easier for the medication to get into the hands of those who need it, experts said.

As overdose deaths—particularly from opioids—continue to rise in the US, newly proposed action by the US Food and Drug Administration (FDA) could have a major impact on the crisis.

In a Federal Register notice issued November 15, the administration indicated that certain naloxone products may be safe and effective for over-the-counter use.

Naloxone is an FDA-approved prescription medication to reverse opioid overdose. Some states allow pharmacists to dispense naloxone without a prescription, known as a standing order. The medication is also available through community-based programs, public health groups, or local health departments—but the newest move by the FDA could further increase accessibility.

“For my patients, it would just make it easier for them to get naloxone,” Cresta Jones, MD, FACOG, physician and associate professor of maternal fetal medicine and addiction medicine at the University of Minnesota Medical School, told Health. “You could just go to any kind of pharmacy, and kind of discreetly buy it [...] that's going to help people have access. It's going to help us have those conversations.”

For now, the FDA's assessment is only preliminary—it's not a final determination of safety and efficacy, nor is it a mandate for OTC designation—rather, it's meant to "facilitate development and approval of nonprescription naloxone products," according to a news release.

Here’s what experts had to say about why naloxone is so important, the barriers that often make it difficult to obtain, and how the FDA’s decision could significantly influence the course of the opioid epidemic in the US.

Naloxone: A Life-Saving Medication 

Naloxone—commonly sold under the brand name Narcan—is an opioid antagonist, which means it works by adhering to opioid receptors in the body by blocking the actual opioid drug from attaching to those receptors, according to Alison Lynch, MD, MS, psychiatrist, addiction medicine specialist, and director of the addiction and recovery collective at University of Iowa Health Care.

“If somebody is having an opioid overdose where they have strong or a lot of opioids in their system that are attached on their opioid receptors and causing opioid effects—which includes slowing down or stopping breathing—naloxone can be administered,” Dr. Lynch told Health. “It knocks those opioid chemicals off and protects the receptor and stops the breathing cessation action.”

The medication is typically given by either injection or nasal spray—the FDA said that a 2 milligram injection given in the muscle or under the skin, and a 4 milligram nasal spray are both being considered for this new over-the-counter status. Both kinds are effective when administered early, Drs. Lynch and Jones said, though the specific situation could determine which type a person might want to administer.

For instance, the nasal spray is easy to use, said Dr. Lynch, especially for people who are scared of needles or who may not feel comfortable giving someone else an injection. But if a person experiencing an overdose isn’t breathing, said Dr. Jones, an injection may be the best route for quick absorption.

The key aspect of the medication, however, is that it can’t be administered by the person who’s experiencing the overdose. That means that the family or friends of someone with an opioid use disorder, harm reduction teams, or even just people who want to be good community members often carry naloxone in case they encounter someone who needs the medication.

Critical Medication That’s Often Hard to Get

Despite naloxone’s ability to reverse potentially fatal opioid overdoses, the drug is not always easy for people to access, especially for those who have opioid use disorders.

Currently, the drug is only approved by the FDA for prescription use—and the Centers for Disease Control and Prevention (CDC) estimate that just one prescription for naloxone is written for every 70 prescriptions for high-dose opioids.

Luckily, all 50 states have passed access laws that make it possible for anyone to access Narcan nasal sprays without a specific individual prescription.

"It's still more what we call 'behind-the-counter,'" said Dr. Jones. "For a lot of states, that’s a standing order from a doctor in the Department of Health or a doctor over a series of pharmacies that sort of says, ‘For anyone who comes in, I give permission for them to get this medication.’”

Some cities have even been experimenting with so-called Narcan vending machines—the new additions in cities like Vine Grove, Kentucky and Battle Creek, Michigan have been making headlines. 

Even with these legal loopholes to make it easier for people to access naloxone without an individual prescription, this still isn’t a perfect solution, Drs. Jones and Lynch agreed.

“Although I think the vending machines are great, there's a lot behind the scenes to make those vending machines happen, and there are a lot of areas in the country where those vending machines are simply not available,” said Dr. Jones.

And even the fact that people can get prescription naloxone behind the counter at most pharmacies leaves access barriers intact. The medication could be out of stock, a person may not have insurance, or they may not have the extra money to purchase it, explained Dr. Jones. Plus, it could be physically challenging for people to get, too.

“There's a lot of places where people don't have pharmacies nearby in their community,” said Dr. Lynch. “But almost everybody—in Iowa anyway—has easy access to a convenience store. So if you just go buy [naloxone] at a convenience store, it just makes it a lot more accessible to many more people, more convenient, and also more anonymous.”

That issue of anonymity is also a big concern when it comes to making it easy to access naloxone.

“A lot of people feel uncomfortable, like there's stigma and bias,” said Dr. Lynch. “Having to go and have a personal conversation with somebody and [saying], ‘I'd like naloxone’—if they were going to go and get it from a pharmacist—for some people, they feel like that's disclosing more information that they want to disclose."

Increasing Naloxone Access

With an average of 187 opioid overdose deaths each day in the US, experts believe that making naloxone an over-the-counter product is crucial to help us make progress with the country’s opioid epidemic.

Advocacy groups have for years been pushing for more widespread use of naloxone—the idea is that if wide swaths of people had the medication on hand, regardless of whether they personally had opioid use disorder, there would be medication available if someone needed it.

“By having it over the counter, it just makes it easier for everybody to buy it,” said Dr. Lynch. “You can buy it as somebody who says, ‘I just want to be a good Samaritan, a good community member’—you don't have to identify as or disclose that you have a substance use disorder, you just want to be a good member of society and be able to save a life if that situation presents itself.”

Friends and family of people who use opioids or opioid users themselves should consider having naloxone at the ready, but people who use or who know those who use other types of drugs may also want to carry naloxone—fentanyl, which is more than 100 times more potent than morphine, is sometimes laced in other drugs such as cocaine or methamphetamine. Synthetic opioids such as fentanyl were responsible for 82% of all opioid-related deaths in 2020, so anyone who could come into contact with these substances should have naloxone easily accessible.

If naloxone was available over-the-counter, it would also be easier for people who work in harm reduction or community advocacy to have access to the medication and distribute it to people in circles where opioids are used, Dr. Jones added.

As is the case with anything, there are still some unknowns about what other issues could arise with over-the-counter naloxone. But even though unintended consequences are possible, Drs. Jones and Lynch said that the positives certainly trump any potential negatives.

“If insurance doesn't cover this for people, are they going to have the money to pay for it? Are they going to know how to use it? Is there liability if somebody uses it incorrectly and it doesn't work? There could be rare side effects,” said Dr. Jones. “In the work that I do, those concerns are overwhelmingly outweighed by the pros of having this in the hands of more people who might be there in an environment when somebody overdoses.”

As for when the FDA’s plans could actually become a reality, the experts said it’s hard to know for sure what the timeline could look like. But they both hope it’s coming soon.

“For those of us who do this for a living, it's been so heartbreaking from 2020 on—we were finally starting to get a handle on overdose rates and then to see the numbers climb back up again has just really been frustrating,” said Dr. Jones. “Anything that we can get out there that's going to start to tip that needle, I hope they can do it quickly.”

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Sources
Health.com uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Food and Drug Administration. FDA announces preliminary assessment that certain naloxone products have the potential to be safe and effective for over-the-counter use.

  2. Centers for Disease Control and Prevention. Lifesaving naloxone.

  3. Centers for Disease Control and Prevention. Naloxone.

  4. Centers for Disease Control and Prevention. Understanding the opioid overdose epidemic.

  5. The Ohio State University. Should I carry Narcan/naloxone?

  6. Drug Enforcement Administration. Facts about fentanyl.

  7. Centers for Disease Control and Prevention. Synthetic opioid overdose data.

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