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Opioid overdose reversal drug likely safe for OTC use, says FDA

Reuters · 11/15/2022 12:28
Opioid overdose reversal drug likely safe for OTC use, says FDA

- Opioid overdose reversal drug may be safe and effective for over-the-counter use in some forms, the U.S. Food and Drug Administration (FDA) said on Tuesday, potentially paving the way for its use federally.

The FDA would still require data on individual products from manufacturers for them to be available over the counter at a federal level.

The drug regulator's preliminary assessment included up to 4 milligrams dose of spray and up to 2 milligrams when given through an auto injector.

The agency said the assessment does cover higher dose products and those supplied in other forms for which more data was .

Doctors can currently prescribe the potentially life-saving antidote when given early, if patients are taking high-dose opioids. It is also available in some states without a prescription or through community programs.

More than 16,000 people have died from overdoses involving prescription opioids in 2020, according to government data.



(Reporting by Raghav Mahobe in Bengaluru; Editing by Arun Koyyur)

((Raghav.Mahobe@thomsonreuters.com;))