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


The drug Naloxone sits on a table during a free Opioid Overdose Prevention Training class provided by Lourdes Hospital in Binghamton, New York, U.S., April 5, 2018. REUTERS/Andrew Kelly

Opioid overdose reversal drug naloxone 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 naloxone nasal spray and up to 2 milligrams when given through an auto injector.

The agency said the assessment does not cover higher dose naloxone products and those supplied in other forms for which more data was needed.

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.