Information Gaps Exist about Opioid Antidote Naloxone, Study Says

Information Gaps Exist about Opioid Antidote Naloxone, Study Says

By Staff.

Administers of Naloxone – the rapidly acting antidote that reverses the effects of overdose with opioids – have important gaps in knowledge about the safety and effectiveness of the drug, which is widely administered off-label among patients, families, friends and emergency responders, says a study published in the Annals of Internal Medicine.

“Naloxone is effective, but we really need to know the best way to administer it,” said senior author Roger Chou, M.D., director of the Pacific Northwest Evidence-based Practice Center at OHSU. “This has both cost and clinical implications.”

In 2015, the FDA approved two prescription versions of naloxone – an auto-injector and a nasal spray formulation.  Many first responders have been using the less-concentrated injectable formulations of naloxone to reverse the effects of opioid overdose. In those emergency situations, they administer it through the nose.

This off-label use has been effectively used by law enforcement treating unconscious overdose victims, but it is researchers say they are uncertain how much naloxone is absorbed and how reliably it is administered.  Both factors could impact the effectiveness of off-label use of naloxone compared with the more recent FDA-approved versions.

“The majority of naloxone being administered nasally is probably the non-approved formulation,” said co-author Mohamud Daya, M.D., professor of emergency medicine in the OHSU School of Medicine. “The sad thing is, we don’t know much about the new formulations. They’ve not actually been well studied in the way that you’d want them to be in a large population of patients.”

One thing clinicians and first responders do know is that the new FDA-approved formulations are expensive – costing as much as $4,000 for the auto-injector.

Researchers reviewed 13 published studies to determine how the route of administration and dosing outside the hospital affects mortality, reversal of overdose symptoms and harm. The evidence appeared to show similar effectiveness between the intramuscular and intranasal delivery for heroin or prescription opioid overdose, but the intranasal naloxone studied was at a concentration different than the FDA-approved nasal formulation.

Researchers also noted that little is known about the efficacy and safety of off-label use of naloxone for treating overdoses related to newly emerging illicit uses of more powerful opioids such as fentanyl and fentanyl derivatives.

“The off label may be fine for most overdoses related to standard heroin or prescription opioids, but may not be strong enough for these other drugs,” Chou said.

It’s important for new research to examine the effect of these off-label uses, he said.

“These jury-rigged intranasal devices have not been tested the same way,” Chou said. “The fact that we have no evidence on the off-label uses for these devices is concerning, especially because many first responders feel compelled to use them because of the cost differences.”

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Authored by: Staff

There are 7 comments for this article
  1. F.S.T. at 1:46 pm

    I had one experience with Narcan years ago, and it was with a home health patient who, when I, a practicing Home Health RN, arrived at her home, was laid out on her couch, breathing extremely shallow at only 6 breaths per minute. I could not awaken her, so I dialed 911. In minutes, they were there and immediately injected Narcan. She came around immediately, sat up, and was madder than a wet hen! She was experiencing sudden horrific intractable pain! So she let us all have it, and told us to never ever do that again, as that was the only way she could get relief from her cancer pain! Fast forward twenty years to today: The CDC and DEA hold the injection over us, and I am the patient suffering with chronic pain. I fully understand the lady who suffered that day. We denied her the right to feel less or no pain. Do others really have that right to take ours away? Something to think about.

  2. Ibin at 10:06 am

    As a past volunteer firefighter, I have seen nalaxone used. It is quickly effecteive but i Do not know of what composition, good or bad…it was.
    Is there an antidote to lead posining. The CDC misguided “policy” and the rogue DEA enforced compliance of it to our physicians, after being reuduced in medication one year ago is really beating me down.. Unemployed, life savings almost gone, ss disability pending.Sorry can’t stay on topic. Worst day in a long time. Enforced compliance is harming many responsibe patients using very effective opiod medications. People that would rather “quit”
    , than turn to illicit or other means of pain management. Never seen such gastapo tactics. as the DEA is getting away with. Lived 59 years, 24 with “chronic”.pain successfully mahaged with opiod medication. WTH does any medically trained person expect from people that exceed CDC “compliance” of maximum dosage, reduced after years or decades? Very effing tired. written and called state reps and our “elect” until I am discouraged. Thought maybe I could…..comply with maximum dosage and stay employed and remain self sufficient as I have for decades. Not possible. Damn those that just don’t understand or are willing to understtnd intractable pain. It’s tough! Money being made somewhwere because DOT/GOV really don’t care if you live or dye.Good luck to all with intractable pain. Press on.

  3. Kathy C at 8:38 pm

    The Pharma Industry created this problem, and now they have an Expensive “Solution.” This migh be why there was no funding for Intervention or Treatment. They can cash in on the Nalaxone after an Addict has Overdosed. They have a repeat customer, becasue without Treatment, they will just end up overdosing again. The Pharma Industry lied about the Opiates in their clever Marketing Scheme, where the peddled their Timed release opiates for Post Surgical Pain and apparently everything else. They Marketed a clever and expensive Pharma Product, while the Medical Industry ignored the risks.
    They have the Media pushing the “Opiate Epidemic” using conflated numbers, to hide the deaths for other non opiate Pharma Products. As people die from Street drugs like Heroin and Fentanyl, they are intimidating the last few Doctors that treat Chronic Pain.
    I read that our President is putting Kelly Anne Conway in charge of this epidemic, his Son In Law is busy with bringing peace to the Middle East. They are still Gas Lighting the Public about the Epidemic of Despair, while the Media presents former Janitors as “Addiction Experts.”
    Many of us would not even be dealing with Pain if we had been born in Canada or any other developed nation.

  4. Michael G Langley, MD at 8:44 am

    Karl, it is not new! It has been around for 47 years! It was around when I completed medical school, in 1979.

  5. Janice Snyder at 8:21 am

    Karl Zaremba,
    How funny that we both honed in on the same thing in this article, i. e., the $$$. So I guess we are snark together.

    My take on this is that when the government intervenes, it is not because they are good Samaritans, but a case of follow the money. In this case it is money spent. Take a $4,000 injection, add an ambulance ride, treatment and recovery in a hospital and you have a good chunk of change being laid out on a person with probably no insurance and no means of paying the bills for keeping the person alive.

    Take that scenario and multiply by the thousands of people who overdose on opiods, fentynal, and heroine, you have a significant chunk of change being laid out and eventually absorbed by hospitals.

    The answer, go after the only group that can actually be controlled – – the prescription users.

  6. PersonInPain at 7:45 am

    Many first responders have been using the less-concentrated injectable formulations of naloxone to reverse the effects of opioid overdose. In those emergency situations, they administer it through the nose.
    Are they injecting it in the nose? Why $4000 for the auto injector? What does this mean? The drug companies expect police departments to pay $4000 for this auto injector. Can it be used more than once? If not, will they pay that much? There is virtually no funding for rehab for addicts so $4000 for a dose to save them from OD seems crazy. Use the traditional needle and put the money towards rehab.

  7. Karl Zaremba at 4:52 am

    Something new is expensive ? At the risk of sounding snarky… Surprise Surprise. I dont know about others but now that I am being reduced dramatically from the meds that work I am finding that alternative treatments and any kind of assistance is very expensive. Everything in 2017 America has to be a big profit center.

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