FDA Pushes for Over-the-Counter Naloxone

In early 2019, the FDA announced that they would be supporting efforts to move naloxone from a prescription drug to an over-the-counter product. In an effort to speed up the process, the FDA developed and tested naloxone Drug Facts labels (DFL) required for OTC products.  The Drug Facts label is the panel published on all OTC products and contains information on active ingredient, purpose, uses, warnings, and directions for taking the product.  The FDA has never preemptively developed and tested an OTC DFL, which is a testament to their commitment to provide better naloxone access. There are two DFLs available from the FDA, one for naloxone nasal spray and another for a naloxone auto-injector. There is no denying that naloxone is a valuable tool to prevent opioid overdose deaths, but there may be additional barriers that limit uptake of OTC naloxone.


While the cost of saving a life is immeasurable, those who do not know they or their loved ones are at risk for an opioid overdose may not see the value in obtaining naloxone. Manufacturers and the FDA should work to ensure that access to OTC naloxone is not cost prohibitive.


The ease of access to naloxone may also factor into a patient’s interest in obtaining the product. If they are required to purchase it behind the counter and present an ID, that may scare off some from purchasing naloxone.  If/when naloxone can be purchased in the front-end of a store, access could increase for patients/caregivers.  The price point of the OTC product may influence access even in the front end as this could prove to be a highly pilfered item.


While no one knows who patients are buying the naloxone for, there is still a stigma surrounding naloxone as a medication to save drug addicts. The general public may not be aware of the potential for accidental overdose of legal opioids and the benefits of naloxone. There are also people who believe that naloxone shouldn’t be so widely distributed when other lifesaving medications (i.e., epinephrine injections and insulin) are restricted and have a high out-of-pocket cost.


Pharmacists should be sure patients using opioid medications and their caregivers are aware of the risks of opioid overdoses and the potential for naloxone to reverse the effects. Family members and friends of someone with a drug problem should also be educated on the availability and uses of naloxone as a lifesaving medication. Pharmacists and healthcare providers should use each opportunity to educate patients, caregivers, and the general public about the benefits of purchasing naloxone in case of emergency.

All states currently allow for naloxone to be obtained at the pharmacy without previously obtaining a prescription. OTC naloxone will expand access to the product and ideally get it in the correct hands to prevent overdose deaths.

You can learn more details by reading the FDA’s statement on efforts to develop over-the-counter naloxone at https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-naloxone


Posted: April 2019

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