- The FDA issued a notice this month that some naloxone products have the potential to be safe and effective for over-the-counter use.
- Naloxone, more commonly known by its brand name Narcan, is a drug used to reverse some of the effects of opioid overdose.
- The American Medical Association (AMA) and the American Pharmacists Association support making naloxone more widely available to help save lives.
This month U.S. Food and Drug Administration (FDA)
Naloxone, more commonly known by its brand name Narcan, is a drug used to reverse some of the effects of opioid overdose.
The FDA notice does not mean that the drug can be bought OTC, instead, it means we are one step closer to the drug’s prescription status being removed and being reclassified as an OTC drug.
The products included a 4 mg nasal spray and up to 2 mg for autoinjector (a one-use spring-loaded syringe) under the skin or into muscle. While this does not mean that those products will be available for OTC use right away, it does provide a path for data to be submitted for the potential OTC use of naloxone.
When it is administered, the naloxone binds with the opioids to stop the slowing of breathing that accompanies opioid use and blocks the drug from causing further symptoms.
The drug can be given through a nasal spray or through injection into muscle, under the skin, or directly into a vein.
Since naloxone only works for a short period of time, anyone who has overdosed needs medical attention even after the administration of naloxone. It has no effects on those who have not taken an opioid.
The American Medical Association (AMA) and the American Pharmacists Association support making naloxone more widely available in order to save lives.
“If not for naloxone, tens of thousands of additional Americans would likely have died, which is why we
need to remove all barriers to naloxone. We agree with the CDC that ‘naloxone saves lives—but only if
it’s readily available when an overdose occurs.’ The AMA urges removing the prescription status of
naloxone as an essential step to save lives from opioid-related overdose because it will help make
naloxone more readily available to patients everywhere,” CEO And Executive Vice President of American Medical Association Dr. James Madara said in a
While naloxone is supposed to be available in pharmacies without a prescription in all states but Hawaii, it is not an over-the-counter drug. Instead, it is often considered a behind-the-counter drug meaning you will likely have to talk to the pharmacist to obtain it.
A 2020 study found that while many pharmacists had been asked about opioid abuse and overdose and needle exchange programs, they often could not provide any information on those programs, treatment, or what to do in event of an overdose, although 83% agreed that this information was needed.
If naloxone became available for OTC use, it could be purchased without the need for a pharmacist or medical professional to dispense it.
Dr. Tucker Woods, the chair of the emergency department and associate medical director of Lenox Health Greenwich Village, board certified in addiction medicine, says making naloxone available OTC could be a huge help in fighting the rise of deadly overdoses.
“We are currently experiencing the highest number of opioid overdose deaths that the country has ever seen. Naloxone is an extremely effective medication that reverses an opioid overdose; in other words, naloxone is an antidote to opioid overdose. Previously naloxone was only available with a prescription. By making it available as an over-the-counter medication, we will be able to expand access and get naloxone into more hands. This is an effective public health approach that will ultimately save more lives given the scope of the opioid epidemic.”
If people learn how to spot the signs of overdose and what to do next, having easily available naloxone could mean that anyone can take steps to save the life of a person experiencing a potentially deadly overdose. A 2020 study took 810 adults and trained them to recognize the signs of opioid overdose as well as when and how to administer naloxone (through nasal spray or injection). The researchers found that almost 80% were able to understand and implement the training when needed.
Fatalities related to opioids have reached record highs in recent years.
An estimated 80,205 people died from opioid overdose in 2021.
To combat these rising rates the FDA has taken steps to help improve access to life-saving medication like naloxone.
They have also recommended that anyone
Not all naloxone products are included in the recommendation.
Naloxone administered through an ordinary syringe instead of an autoinjector and doses that are higher than the 4 mg nasal spray and 2 mg autoinjector are not covered. The FDA says that more information is needed on the safety and effectiveness of these higher doses before they can recommend their use to the general public.
Several different things need to be done to ready naloxone for OTC use. A drug facts label that explains the dose per nasal spray or autoinjector and what is the active ingredient must be prepared. Pictograms describing how to use naloxone and when also may be added. Even with those requirements put in place, final approval for OTC sale may take some time. But the FDA recommendation has given OTC naloxone a big step forward.