April 18, 2023

FDA Approves First Over-the-Counter Naloxone Nasal Spray

The FDA has approved Narcan (naloxone hydrochloride) 4mg nasal spray for over-the-counter (OTC) use – the first naloxone product approved for use without a prescription.

Naloxone rapidly reverses the effects of opioids and is the standard treatment for opioid overdose. As opioid pain medications are commonly used in workers’ comp and come with risk of overdose even when used properly, this approval makes this life-saving drug more accessible for injured worker patients.

Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. In accordance with a process to change the status of a drug from prescription to nonprescription, the manufacturer provided data demonstrating that the drug is safe and effective for use as directed in its proposed labeling. The manufacturer also showed that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.

The approval may also affect the status of other brand-name naloxone nasal spray products of 4 mg or less, but determinations will be made on a case-by-case basis and the FDA may contact other firms as needed.

The use of Narcan nasal spray in individuals who are opioid dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.

For ongoing coverage of the latest drug approvals and alerts impacting workers’ comp, visit Med Monitor online.

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