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The U.S. Food and Drug Administration has approved another over-the-counter intranasal naloxone product, Rextovy (naloxone hydrochloride), for the emergency treatment of opioid overdose. The nonprescription approval was granted to Amphastar Pharmaceuticals.
The 4-mg nasal spray is available for purchase by consumers in pharmacies, convenience stores, and online. The product’s packaging includes five-step pictorial directions, including calling 911 after giving the first dose.
When regaining consciousness after the overdose reversal, some people may experience symptoms such as shaking, sweating, nausea, or feeling angry. The product is safe to use even if it is uncertain whether opioids are the cause of the overdose.
“Reducing opioid overdose deaths is a top priority for the FDA,” Mike Davis M.D., Ph.D., from the FDA Center for Drug Evaluation and Research, said in a statement. “Today’s approval of an additional over-the-counter naloxone nasal spray helps broaden access and offers an additional option for consumers. Empowering people without medical training to take immediate action with these products has been proven to save lives.”
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