Over the counter Narcan nasal spray containing a 4-milligram dose of naloxone was approved Thursday by the U.S. Food and Drug Administration.
Louisiana State Health Officer Dr. Joe Kanter told WWL’s Dave Cohen this week the life-saving drug that can reverse an opioid overdose also happens to be “amongst, if not the safest,” drugs around.
“Of all the drugs that I use on a day to day basis when I work in the E.R., Narcan is amongst, if not the safest,” he said. “Because if it’s given to someone that’s not overdosing, it has zero effect – doesn’t get them high, doesn’t get them low, doesn’t do anything. The only effect it has is to reverse an opioid overdose if that’s in place.”
Naloxone is an opioid antagonist, and it works by blocking the effects of opiates, the National Library of Medicine explained. According to a press release from Sen. Shelley Moore Capito (R-W.V.), Narcan was first approved by the FDA in 2015 as a prescription drug.
“Narcan has previously been by prescription only, which is the way pharmaceutical companies wanted to keep it, despite FDA support of OTC sales,” said the release. “But thanks to a bipartisan, bicameral group, including… [Senator] Joe Manchin, a Democrat, pressure was put on seven major manufacturers of naloxone products, which includes Narcan, a nasal spray, to apply for over-the-counter status for those products.”
Per the FDA, approving Narcan spray for OTC use “paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.”
Drug overdose deaths in the U.S. have been in the rise for the past two decades, according to the U.S. Centers for Disease Control and Prevention. In 2021, the rate of drug overdose deaths was significantly higher than in 2020. That year, the rate of drug overdose deaths involving synthetic opioids other than methadone increased 22%, while the rate of deaths involving heroin declined 32%. Since synthetic opioids have increasingly been found in drugs such as cocaine, people are not always aware they are at risk for an opioid overdose.
While the OTC availability of naloxone is “long overdue,” according to Kanter, he said Narcan spray will most likely not appear on convenience store shelves immediately.
“This decision by the FDA is going to put it over the counter, you know, in the front of the store like all the other… over-the-counter meds are. It’s going to make it easier to get,” he said. “It will take some time to implement. You know, this is not going to happen immediately. But we think three or four months, you know, for the pharmaceutical companies to start producing the new packaging and getting out there and then it’ll be out there.”
Listen to Dr. Kanter’s full conversation with Cohen here.
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