The FDA approved Rextovy as another over-the-counter (OTC) naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose.
Approvals like this are important because opioid pain medications are commonly used in workers’ comp, and even when used responsibly, opioids come with various risks, including potential overdose and death. Certain high-dose opioids are sometimes even co-prescribed with naloxone medications in the event of overdose, while individual patients with heightened risks of opioid overdose, even at lower doses, may also be prescribed naloxone.
Rextovy was originally approved by the FDA in 2023 as a prescription medication, and this new approval allows consumers to directly purchase this product without a prescription in places such as pharmacies, convenience stores, and online.
The approval of Rextovy as an OTC is the third nonprescription naloxone product the agency has approved, helping increase consumer access to naloxone without a prescription. The timeline for availability and the price of this nonprescription product will be determined by the manufacturer.
When using Rextovy, some people may experience opioid withdrawal symptoms when they regain consciousness following overdose reversal, such as shaking, sweating, nausea, or feeling angry.
The product is safe to use even when it is uncertain whether opioids are present in the person’s system. The product’s packaging includes pictorial directions with five clear steps, including calling 911 after giving the first dose.
Naloxone may be appropriate for patients on high doses of opioids or at an increased risk of opioid overdose. Per CDC Guideline for Prescribing Opioids for Chronic Pain, naloxone products such as Rextovy, Narcan, Kloxxado, and Zimhi are recommended for any patient at risk for an opioid overdose (e.g., morphine milligram equivalents (MME) > 50).
OTC naloxone may provide cost savings and increased access to a life-saving medication. However, patients on chronic opioid therapy still require in-depth evaluation of the current treatment plan; appropriate management and discontinuation of opioid therapy should remain the ultimate goal whenever possible.
For ongoing coverage of the latest drug information and alerts impacting workers’ comp, visit Med Monitor online.
