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WASHINGTON — The Food and Drug Administration announced Thursday that it would require drug manufacturers to include information about naloxone, the overdose-reversal medication, on the labels of opioid painkillers.

The move comes just weeks after the federal government released new data showing that U.S. drug overdose deaths reached an all-time high in 2019, surpassing the previous peak recorded two years earlier. More recently, the Covid-19 pandemic has led to another increase in overdose deaths as the unemployment rate has skyrocketed and Americans have lost access to health insurance and to many in-person health services like addiction clinics or syringe exchanges.

Naloxone, often referred to by the brand name Narcan, has been used in the U.S. to reverse opioid overdoses since 1971. While it’s often prescribed in an injectable form, it’s also commonly sold as a nasal spray or a mechanized auto-injector, which make the medication easier for people without medical training to deliver.

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“Today’s action can help further raise awareness about this potentially life-saving treatment for individuals that may be at greater risk of an overdose and those in the community most likely to observe an overdose,” Stephen Hahn, the FDA commissioner, said in a statement.

The FDA’s announcement is the latest step in a nationwide effort to distribute naloxone more widely, both to people who use drugs and people likely to witness opioid overdoses.

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The Department of Health and Human Services recommended in 2018 that physicians prescribe naloxone alongside opioids to patients at high risk for overdose, like those on high opioid doses or those who take the pain drugs alongside benzodiazepines, a class of medications used to treat anxiety and other health conditions.

In recent years commercial health insurers and local governments have also moved to make naloxone more widely available, including covering the medication at no cost and issuing “standing orders” so that any individual can purchase naloxone at a pharmacy, even without a prescription.

The FDA also said it would require similar labels for the three approved drugs used to treat opioid addiction: methadone, buprenorphine, and naltrexone.

While the move is likely to result in increased awareness and use of naloxone among patients who use prescription opioids for pain, it’s unclear whether it will help reduce overdose deaths for people who use illicit opioids like heroin.

Fentanyl, the ultra-powerful synthetic opioid that illicit drug manufacturers often include in illegally manufactured pills or in heroin itself, is also a major driver of drug overdose deaths.

  • I used to be one of those who, while sympathetic, would look down on those who’d ‘allowed’ themselves to become addicted to alcohol and illicit drugs. However, upon learning that serious life trauma (e.g. adverse childhood experiences) is so often behind the addict’s debilitating addiction, I began to understand ball-and-chain self-medicating. The greater the drug-induced euphoria or escape one attains from its use, the more one wants to repeat the experience; and the more intolerable one finds their sober reality, the more pleasurable that escape should be perceived. By extension, the greater one’s mental pain or trauma while sober, the greater the need for escape from reality, thus the more addictive the euphoric escape-form will likely be.
    Yet, in many straight minds drug addicts have somehow committed a moral crime, perhaps even those who’d become addicted to opiates prescribed them for an innocent sports or work injury.
    We now know pharmaceutical corporations intentionally pushed their very addictive opiate pain killers—the real moral crime—for which they got off relatively lightly, considering the resulting immense suffering and overdose death numbers.

  • This article points out the chaos and insanity in this “opioid epidemic”.
    – Fentanyl and all opiates have an equipotent dose. It is only “ultra-powerful” when it comes from an illegal lab, where concentration is unknown and even stronger analogs are likely in the mix. And who knows how it was cut by your dealer? Your party-time “oxycodone” pill could have zero drug in it, or 100x fatal overdose. They would look the same.
    Already, naloxone doesn’t require a prescription. Just go buy it. But it often gives a false sense of security. You need to be awake to give it. Overdose puts you to sleep. You’re still dead with the auto injector in your pocket.
    And please don’t mistakenly give it to the guy having a heart attack as the adrenalin storm will probably kill him.

  • Less 💊 = Less deaths. First they addict them; then they bring them back to life; then they treat them. All 3 cash cow for the drug companies.

    • In many sober minds these poor souls have somehow committed a moral crime, perhaps even those who’d become addicted to opiates prescribed them for an innocent sports or work injury. We now know pharmaceutical corporations intentionally pushed their very addictive opiate pain killers – the real moral crime – for which they got off relatively lightly, considering the resulting immense suffering and overdose death numbers.

  • Whenever I look at my comments in here I almost always referring to acupuncture and I believe I am in favor of this paradigm.

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