FDA: Naloxone Injector Not Just for Drug Abusers

FDA: Naloxone Injector Not Just for Drug Abusers

A device developed to save the lives of heroin addicts and other narcotic drug abusers is now being touted as a lifesaving treatment for pain patients who overdose on prescription opioids.

65311-Evzio1-original-originalThe Food and Drug Administration has approved a handheld injector called Evzio that delivers a single dose of the drug naloxone to people suffering from a potentially fatal overdose.

Family members and friends of drug addicts – or even patients taking opioids for a medical condition – are being encouraged to get the device and keep it at home as an emergency treatment for loved ones. The injector, which must be obtained through a prescription, can be carried in a pocket or stored in a medicine cabinet.

“A family member of someone at risk for opioid overdose could receive a prescription,” said Dr. Douglas Throckmorton, deputy director at the FDA’s Center for Drug Evaluation and Research. “Physicians can prescribe to anyone concerned about the risks of possible opioid overdose.”

Naloxone rapidly reverses the effects of a narcotic overdose – such as respiratory depression – which can cause someone to stop breathing or lose consciousness. However, existing naloxone drugs have to be injected with a syringe and are most commonly used by trained medical personnel in emergency departments and ambulances.

Evzio is designed to be used by lay people. Once turned on, Evzio provides verbal instructions on how to deliver the medication, similar to how an automatic heart defibrillator works.

“There was a great emphasis on making it very user-friendly, both the labeling information and the device itself,” said FDA commissioner Margaret Hamburg. “The last instruction the device gives is to call 911, because this product is not a substitute for emergency care.”

Drug overdose deaths are one of the leading causes of accidental death in the United States and the FDA is under increasing political pressure to combat what has been called an “epidemic” of prescription drug abuse. More than 16,000 Americans die each year from opioid overdoses, although in many cases alcohol or other drugs are involved.

“The FDA will continue to work to reduce the risks of abuse and misuse of prescription opioids,” said Hamburg.

“We know that the illegal diversion, misuse, and abuse of prescription opioids are often fueled by inappropriate prescribing, improper disposal of unused medications, and the illegal activity of a small number of health care providers. This highlights the important role that education of prescribers and patients can play in addressing this epidemic.”

The FDA fast-tracked the approval of Evzio in just 15 weeks under the agency’s priority review program.

Authored by: Pat Anson, Editor

There are 4 comments for this article
  1. Myron Shank, M.D., Ph.D. at 8:06 am

    @Kurt:

    I am not sure why you are so concerned about the possibility of receiving naloxone, should you become unconscious for an unrelated reason.

    First responders already give naloxone to anyone with unconsciousness without another known cause (such as trauma). Even if they did not do so, you can be sure that emergency room physicians would. This voice-prompting injector merely makes it easy for someone with absolutely no medical training to do so before first responders can arrive.

    Assuming that you were unconscious for a reason unrelated to your pain medications, naloxone would not reverse your coma. You would probably be unaware of any precipitated withdrawal and of your chronic pain.

    Are you concerned about more serious complications? Quoting from the approved labeling, “Although a direct cause and effect relationship has not been established,
    after use of naloxone hydrochloride, patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects
    should be monitored for hypotension, ventricular tachycardia or fibrillation, and pulmonary edema in an appropriate healthcare setting.” If so, whether or not you received naloxone, and, if you did, whether or not you had those conditions or took those medications, and whether or not naloxone reversed your coma, you would need to be monitored in “an appropriate healthcare setting” anyway.

    I would caution against listing naloxone on a Medical Alert, unless you have a known intolerance (apart from chronic opioid therapy) for the drug. I am not an attorney, but it seems that such a “refusal” while competent would have to be honored when you were incapable of reconsidering it. Assuming that you survived to reach the hospital, it is true that your breathing could be maintained, while waiting for any opioid effects to wear off. However, do not forget that naloxone is not only therapeutic but diagnostic–failure to awaken after its administration points to a non-opioid cause for the loss of consciousness. I am concerned that refusing naloxone might delay recognition and treatment of those same unrelated causes for loss of consciousness that loom so large in your fears. Human nature being what it unfortunately is, in fact, putting that refusal on a Medical Alert might even tend to emphasize opioids as the presumed cause of coma. Given the prejudices of most medical personnel against opioid drugs and the people who use chronically use them, I would not feel comfortable providing any rationalization not to pursue other possible causes, because an opioid overdose could not be quickly excluded.

  2. Kurt at 8:56 pm

    @Dr. Shank, Thank you for your thoughtful response.

    You make excellent points, and the one that sends chills is that a visitor, for instance, my grandson, accidentally swallows a 60 mg OC tablet. After all, the brown pill does look very much like a certain brand of OTC ibuprofen.

    I am also concerned for many chronic pain patients using opiates who may loose consciousness for other reasons. As soon as a first responder hears the list of medications, in goes the Narcan pen.

    If we’re going to make these things available to policemen and other untrained first responders, they need to understand that any medication can do more harm than good if used when contraindicated. I have worn a Medical Alert tab for 30 years due to a congential blood disease, and I’m giving serious consideration to having them add the words NO NAXOLONE.

    As you point out, life is not always as simple as a politician, Joe Sixpack, or even the Governor of Massachusetts may believe it to be.

  3. Myron Shank, M.D., Ph.D. at 8:02 pm

    @ Kurt: This device is not intended for use apart from a possible overdose. As you have correctly noted, however, that is unlikely to happen with chronic stable doses. Nonetheless, given the statistics about “accidental overdoses” of “prescription-type” opioids (whether prescribed to the one overdosing on them or not!), the injector is likely to quickly become standard of care for those who are prescribed higher doses or larger quantities (ANY?) opioids.

    Why should you (or your insurer) be required to purchase one of these?

    I can imagine legal or insurance pressures upon physicians not to continue to prescribe opioids, unless a patient demonstrates that he possesses one of these devices. Pharmacies may even begin to require the same, before they will dispense opioids. Worse, these measures might even be interpreted to preclude prescriptions of opioids AT ALL, unless someone was (continuously) present to monitor and rescue the one to whom they were prescribed!

    Of course, these measures will have little impact upon accidental overdoses by those who illicitly take opioids, “prescription-type” or otherwise, unless they take place in the homes of those with legitimate prescriptions for licit opioids.

    On the other hand, I could also imagine a scenario in which a pain patient who customarily had no need to worry about someone else gaining access to his medications had a visitor (perhaps a small child) and did not think to temporarily secure his opioids. Having rescue medication on hand for such an event could save someone else’s life.

    One could argue that, in an ideal (in other words, unreal) world, accessibility to a naloxone injector ought to be an argument against irrationally restrictive use of opioids for their intended purposes.

    Just as with other tools (including opioids, themselves), the benefits need to be balanced with the costs. As the above discussion demonstrates, it is unlikely that the balance would favor the same choice in every case. Unfortunately, human beings (especially the political sort) seek simplicity in complexity–often to the exclusion of good sense. Whether or not this will happen with the naloxone injector remains to be seen.

  4. Kurt at 7:14 pm

    I guess I need a new Medic Alert tab for my necklace in case I faint the next time I am in Safeways shopping for dinner, and succumb to shock over the high prices they’re charging these days for a pound of hamburger.

    I am a chronic pain patient maintained on opiates.

    DO NOT INJECT WITH NALOXONE. I am opiate tolerant and not likely to overdose on opiates. Naloxone could put me into immediate opiate withdrawal causing a health crisis.

    Lord keep us safe from do-gooders.