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FDA Approves Naloxone for Over the Counter Use: How Does This Address the Opioid Epidemic?

6 mins read
Image Source: Medpage Today

By the end of the day, 44 people in the US alone will have died with one common cause of death: an overdose. 

The incessant increase in drug use and drug-related deaths in the United States has been declared a public health emergency since 2017, but our country’s history of substance abuse dates back. 1990s prescriptions of addictive narcotic oxycodone (OxyContin®) are often credited with catalyzing the first wave of the opioid epidemic. Throughout the 2010s, a rapid rise in deaths from heroin-related overdoses shaped the epidemic’s second wave. Most recently however, fentanyl, a synthetic opioid 50x more potent than heroin, has unforgivingly claimed lives nationwide. 

What’s more? Many are not privy to the fact that they have ingested the drug until it is too late. 

The Center for Disease Control (CDC) states that fentanyl is most often laced with other drugs as it closely resembles a host of prescription and illicitly manufactured pills. In fact, users are commonly unaware of fentanyl’s detriments or that it exists in other substances to begin with. Easily turned into liquid, eye drops and nasal sprays, one of fentanyl’s predominant threats is its omnipresence. 

The pressing nature of the fentanyl crisis is especially pronounced in New York City as the drug accounts for approximately 80% of the city’s recorded overdoses. In a metropolis where over ⅓ of a representative sample of high school students admitted to illegal drug use, the threat of fentanyl and fentanyl lacing appears daunting and imminent. While fentanyl test strips are a start to mitigating accidental use of the drug, naloxone works to reverse the critical effects of overdose.

The argument for naloxone’s over-the-counter distribution is a robust one. While naloxone has no effect on an individual without opioids in their system, the opioid antagonist actively binds to opiate receptors, restores respiratory function to normal and reverses opiates’ effects. Administered most commonly through Narcan® nasal spray, naloxone is at all times easy to use and instrumental in circumventing adverse reactions during overdose. In addition, it works to combat the dangers not only of fentanyl but all opioids including oxycodone, methadone, morphine, codeine and heroin among others. 

       Image Source: Harm Reduction Coalition

FDA commissioner Robert M. Califf M.D expressed in a recent statement, “[The] 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.” In issuing the statement, Califf referred to the gravity of naloxone’s influence and its potential to save lives on a larger scale.

While the FDA’s approval of over-the-counter naloxone use is a step in addressing the opioid epidemic’s increasing death toll, some believe naloxone is merely an incentive for addicts to keep using due to the almost guaranteed relief it provides. Broadly, critics of naloxone and therefore Narcan® generally disfavor a concept called harm reduction. In the realm of addiction, harm reduction works to facilitate safe and managed drug use for individuals who are not seeking total substance abstinence.

The principle of harm reduction has faced its fair share of challenges in the United States political climate. With former California governor Jerry Brown vetoing a bill for safe, sterile drug consumption sites and the city leaders of Appalachia shutting down a needle-exchange program, political leaders have been quick to question harm reduction’s efficacy. Nonetheless, naloxone is a fundamental aspect of the harm reduction movement and its approval entails some notable benefits.

For states that have implemented naloxone accessibility laws, overdose death rates have since decreased by 14%. All the more, a study found 93.5% of people survived their overdose when Narcan® was administered. In New York, a state where upwards of three people die from an overdose each day, these numbers provide a sense of what good could come of further naloxone and Narcan® availability. 

Ultimately, naloxone is evidently advantageous but by no means a solution to the opioid epidemic. However, its approval for widespread use indicates progress towards recognizing the opioid epidemic as the dire public health emergency it is.

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