Tags: fda | narcan | naloxone | nose spray | otc | overdose | opioid

FDA Staff Flag No New Safety Concerns for OTC Narcan

FDA under a magnifying glass
(Dreamstime)

Monday, 13 February 2023 10:36 AM EST

The U.S. Food and Drug Administration's staff reviewers on Monday did not flag any new safety concerns related to Emergent BioSolutions Inc's over-the-counter version of nasal spray Narcan for reversing opioid overdose.

The FDA's advisory panel will meet on Wednesday to discuss the first OTC version of Narcan, or naloxone, used to prevent death by overdose.

Citing concerns related to the use of Narcan for other indications than the one it is prescribed for, staff reviewers said they believe there are less chances consumers will use it mistakenly if prescription-free sale is allowed.

"For the nonprescription product, patients or caregivers will have to select the product for the suspected or known opioid overdose off the shelf, thereby knowing why they are purchasing the medication," said staff reviewers in briefing documents published on the agency's website.

FDA approval for an OTC version of Narcan could increase its availability and would align the federal government's stance with that of various states that have provisions to offer Narcan or naloxone without prescriptions through a pharmacist.

Naloxone rapidly reverses or blocks the effects of opioids, restoring normal respiration.

Deaths related to opioids such as the powerful synthetic painkiller fentanyl soared during the pandemic, worsening an already tragic and costly nationwide opioid crisis.

Staff reviewers added that they expect the advisory panel later this week to discuss further considerations to improve labeling of Emergent's product to ensure safe and effective use by a consumer in an emergency situation. 

© 2025 Thomson/Reuters. All rights reserved.


Health-News
The U.S. Food and Drug Administration's staff reviewers on Monday did not flag any new safety concerns related to Emergent BioSolutions Inc's over-the-counter version of nasal spray Narcan for reversing opioid overdose. The FDA's advisory panel will meet on Wednesday to...
fda, narcan, naloxone, nose spray, otc, overdose, opioid, reverse, emergent biosolutions
243
2023-36-13
Monday, 13 February 2023 10:36 AM
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