FDA Issues Updated Prescribing Information for Opioids & Over-the-Counter Naloxone

OTC Naloxone

In late March, the FDA approved the use of over the counter (OTC), nonprescription naloxone hydrochloride (Narcan) as a 4 mg nasal spray.² Naloxone is a life-saving medication that has the potential to reverse an opioid overdose.

This treatment is the first FDA-approved naloxone product that will not require a prescription. It will be sold directly to consumers in pharmacies, convenience stores, grocery stores and other locations. It will also be sold online.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Drug safety communication: All opioid pain medicines—FDA updates prescribing information to provide additional guidance for safe use. U.S. Food & Drug Administration. 2023 Apr 13.
2. News release: FDA approves first over-the-counter naloxone nasal spray. U.S. Food & Drug Administration. 2023 Mar 29.