FDA Approves Over-the-Counter Narcan

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Fun CH
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Re: FDA Approves Over-the-Counter Narcan

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mister_coffee wrote: Thu Mar 30, 2023 3:26 pm And I don't think that people deserve to die because they are addicts.
But you seem to think people who refuse a covid vaccine deserve to die if they contact Covid. What gives?

Hey Jingles, should we pull meds for people who can't control their weight and tend to over eat fats and sugar?
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Can't talk to a man who don't want to understand--Carol King
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Re: FDA Approves Over-the-Counter Narcan

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Here's why parents should keep Narcan at home, an expert says
Story by Angeli Kakade • Yesterday 8:40 AM


Deaths from drug overdoses continue to be a public health issue in the United States according to the Centers for Disease Control and Prevention (CDC). And teens have been impacted at an alarming rate.

The median monthly overdose deaths among those ages 10-19 increased 109% from the last half of 2019 to the last half of 2021. Around 90% of deaths involved opioids, with about two-thirds of the deaths happening with at least one person present at the time of death.

And now advocates are hoping more parents and families take advantage of the drug naloxone now that it's been greenlit for over-the-counter sale, making it the first drug of its kind to be sold without a prescription.

"I think the bigger question is, 'Why wasn't it sooner?'" said David Laxton, the executive director of Newport Healthcare Kirkland which operates two other facilities in Washington that focus on teen drug use and mental health.

Laxton stressed it's not enough for Narcan to be sold over the counter, but his message to all parents is to keep Narcan in the house, make sure it's readily available and know how to use it.

"Many of these kids who overdose, not all, but many.. they are a kid at a party and they think they're taking Xanax or ecstasy or something like that and the reality is it's counterfeit pills that are fentanyl and all of a sudden they've overdosed," said Laxton who added that he understands it's a scary thought for parents to not always know what their kids are doing.

"Enabling and harm reduction are not the same thing," Laxton said.

He's hoping the move by the Food and Drug Administration (FDA) helps reduce the stigma of addiction and drug use.

"I've been in the trenches a long time and I've seen way too many deaths, what this does is it gives someone the chance to fight another day," Laxton said.

Narcan could be sold in convenience stores, supermarkets and online retailers as soon as by the end of the summer.

Laxton said he does want everyone to know the effects of Narcan are temporary, so even if it's administered, you still need to call 911.
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mister_coffee
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Re: FDA Approves Over-the-Counter Narcan

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Given that about 80 percent of opiod addicts got started in their addiction with prescription medications (that were presumably prescribed by a doctor), your image of "junkie" might be a bit out of date. And I don't think that people deserve to die because they are addicts.

And if you were seriously injured and needed painkillers and were prescribed these medications and they were improperly administered or managed I'd argue that the doctor or the company selling the painkiller should be paying for that person's treatment.
:arrow: David Bonn :idea:
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Re: FDA Approves Over-the-Counter Narcan

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So what we are condoning is more drug abuse without fear of fatal repercussions. "Use drugs but keep an overdose counter measure available". Instead of just saying you use drugs you could die seems like the wrong message to send to the druggies.
Kind of like telling toddlers not to stick a butter knife in an electrical socket and then giving them insulated gloves
The choices you make in life have consequences use drugs suffer the consequences
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Re: FDA Approves Over-the-Counter Narcan

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In reality, the "drug problem" we have as a society is pretty complex and multi-dimensional. It is unlikely that there is going to be any "silver bullet" that is going to make that problem go away. About the best we can hope for is to reduce the harm.

Narcan is likely to do that. Although probably not as much as we'd hope or think.
:arrow: David Bonn :idea:
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Re: FDA Approves Over-the-Counter Narcan

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That's a whole other side of the coin that really Narcan accessibility has no control over.
The world has already acknowledged that we can't end drug use, we can fight the cartels and the manufacturers but we can't stop them. As long as there is a demand they will remain in business. And the demand is a monster that demands to be fed.
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Re: FDA Approves Over-the-Counter Narcan

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Yes... It will do that... Just wish we had more in place to keep it from needing it in the first place. :-(
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Re: FDA Approves Over-the-Counter Narcan

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It will save lives.
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FDA Approves Over-the-Counter Narcan

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Narcan over the counter... Now opiod overdoses easily taken care of by anybody... Not sure how I feel about this... Will it increase opiod drug use?
FDA Approves First Over-the-Counter Naloxone Nasal Spray
Agency Continues to Take Critical Steps to Reduce Drug Overdose Deaths Being Driven Primarily by Illicit Opioids

For Immediate Release:
March 29, 2023

Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Today’s action 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.

The timeline for availability and price of this OTC product is determined by the manufacturer. The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only.

Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl.

“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” said FDA Commissioner Robert M. Califf, M.D. “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. In accordance with a process to change the status of a drug from prescription to nonprescription, the manufacturer provided data demonstrating that the drug is safe and effective for use as directed in its proposed labeling. The manufacturer also showed that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional. The application to approve Narcan nasal spray for OTC use was granted priority review status and was the subject of an advisory committee meeting in February 2023, where committee members voted unanimously to recommend it be approved for marketing without a prescription.

The approval of OTC Narcan nasal spray will require a change in the labeling for the currently approved 4 mg generic naloxone nasal spray products that rely on Narcan as their reference listed drug product. Manufacturers of these products will be required to submit a supplement to their applications to effectively switch their products to OTC status. The approval may also affect the status of other brand-name naloxone nasal spray products of 4 mg or less, but determinations will be made on a case-by-case basis and the FDA may contact other firms as needed.

The use of Narcan nasal spray in individuals who are opioid dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.

“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status. Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.”

The FDA has taken a series of measures to help facilitate access to naloxone products. In November 2022, the agency announced its preliminary assessment that certain naloxone products, such as the one ultimately approved today, have the potential to be safe and effective for over-the-counter use and encouraged sponsors to submit applications for approval of OTC naloxone products. The agency previously announced in 2019 that it had designed, tested, and validated a model naloxone Drug Facts Label (DFL) with easy-to-understand pictograms on how to use the drug to encourage manufacturers to pursue approval of OTC naloxone products. The model DFL was used to support the approved application along with the results of a simulated use Human Factors validation study designed to assess whether all the components of the product with which a user would interact could be used safely and effectively as intended.

Through the FDA Overdose Prevention Framework, the agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose and death in the U.S. The framework’s priorities include: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted or counterfeit drugs presenting overdose risks.

The FDA granted the OTC approval of Narcan to Emergent BioSolutions.
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