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WASHINGTON — The Food and Drug Administration on Wednesday chastised the pharmaceutical company Alkermes for “misbranding” Vivitrol, its controversial treatment for opioid addiction, saying the company’s promotional materials failed to warn patients and doctors of the serious risks associated with the drug.

The company failed to sufficiently communicate the risk of overdose associated with Vivitrol, which is one of three FDA-approved medications used to treat opioid use disorder. While Vivitrol guards against opioid cravings and relapse for people in recovery from opioid addiction, it reduces opioid tolerance and leaves its users more vulnerable to opioid overdose for patients who relapse, even at comparatively low doses.


“Vivitrol is being promoted in a way that does not adequately present important risk information in a truthful and non-misleading manner,” Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion, said in a statement. “This is concerning from a public health perspective because of the potential for fatal opioid overdose in this vulnerable patient population.”

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  • They should place a warning on abstinence from opiates as well. Not using opiates also decreases opiate tolerance in the same way Vivitrol does. It literally rests the tolerance. Methadone and suboxone keep people narconized, whereas Vivitrol makes them opiate free-yes, increasing the risk of overdose in relapse. But isn’t stopping opiate use completely the goal?

  • Everyone should be furious with the FDA etc overdose monograph no mention rescue breaths as the morgues fill up needlessly non ODs and ODs.

    Read my comment FDA press release

    FDA Drug Facts Label Protocol no breaths which is essential any of the 100s of causes breathing emergency

    Sheriff’s Office at 45 seconds Sheriff your CPR is killing cops

    Shawn Whatley MD past president OMA ‘Absurd Change’

    “O my love my wife death has sucked the honey of thy breath” Romeo and Juliet

    Psychological terrorism workplace harassment and bullying, needless deaths, stress increasing mental and physical illness drug use and abuse. Common quotes Police; Pharmacists; EMS; MDs and RNs while crying “I know they are increasing morbidity and mortality anyone who is alive with chest compressions and/or oxygen deprivation”

  • I used Vivitrol successfully as a tool the first 9 months of my sobriety. I was informed by my physician the importance of my part to have this be a success. I was on the methadone program for 3 years and at the time, it was helpful but it was just another drug that I had to maintain on a daily basis and the later effects of the withdrawl were intense. When my physician and I chose to end the Vivitrol, I had no problem with not getting the injection. You have to be responsible for your own recovery no matter what is it. I am now 17 months clean/sober and I continue to choose the life I have been given. There is never going to be ONE thing that gets anyone clean. I work at it daily.

    • I’m a doc. Seem opioid epidemic first hand in Western PA. This drug (naltrexone) probably works. This is all politics and propaganda. Thanks goes out to the above patients for commenting..

  • No matter what drug is used when t comes to harm reduction for Opiate use disorders, we will be able to find something that can be seen as dangerous. However it is the least of two evils. It is very important to educate our clients to the risks involved and help them understand what to expect. There is no perfect solution when it applies to addiction.

  • I have used Vivitrol with good success for several years now. I work very hard when signing an informed consent form with patients as to the real and possibly lethal effects of this medication. I remain a huge fan of it, I have accepted no monies ever from Alkermes and see some excellent recovery with its careful use along with counseling support.

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