Has the FDA Increased Access to the Opioid Overdose Medication Naloxone?

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Has the FDA Increased Access to the Opioid Overdose Medication Naloxone?Opioids are powerful medications and illegal drugs that strongly alter the normal function of the central nervous system (brain and spinal cord). People who take too much of one or more of these substances can develop a dangerous, potentially lethal problem called an opioid overdose. Public health officials know that prompt use of a medication called naloxone can steeply reduce the odds that an opioid overdose victim will die; however, until recently, access to this medication was largely limited to licensed physicians. In April 2014, the U.S. Food and Drug Administration simultaneously approved the sale of a naloxone-based product called Evzio and made this product available for use by people not trained as doctors.

The Basics

Opioid overdoses occur because the central nervous system effects of opioid substances can interfere with the automatic nerve signals that keep the body’s most vital organ functions going. Common symptoms of such an overdose include narrowed pupils, hypotension (low blood pressure), loss of alertness or consciousness, and a suppression of normal lung function that interferes with the ability to breathe. When they appear in severe form, both hypotension and breathing suppression are highly lethal problems, and people affected by these issues will die unless they receive some sort of timely intervention.

Naloxone’s Effects

Naloxone interferes with opioid substances’ ability to reach the brain and spinal cord and change the level of activity in the central nervous system. When given to someone in addiction treatment who has discontinued opioid intake, it can help prevent the onset of a relapse back into active use. When given to a person experiencing an opioid overdose, it can produce enough of a blocking effect to help reverse that overdose. When used preemptively in people who excessively consume an opioid drug or medication, it can help stop an overdose from beginning in the first place. In addition, doctors can use naloxone to help diagnose the presence of an opioid addiction in their patients.

Issues of Access

Naloxone is an injectable prescription medication that typically requires the use of a standard needle and syringe for its administration. In the U.S., legal precedent and longstanding medical protocol limit the use of prescription medications to people specifically sanctioned by a licensed doctor. In addition, only licensed doctors carry the authority necessary to write a prescription. Unfortunately, opioid overdoses commonly occur in emergency circumstances that either take place away from a doctor or hospital, or involve people who don’t have a personal prescription for naloxone use. In addition, many of the people who either experience or witness an opioid overdose are drug users who face legal penalties if caught with illegal opioids in their possession. In the U.S., only 17 states and the District of Columbia have laws on the books that allow someone other than a doctor to administer naloxone treatments to an opioid overdose victim.

The New FDA Ruling

Prescription medications can only enter the U.S. market after receiving approval from the U.S. Food and Drug Administration. On April 3, 2014, the FDA approved the sale of Evzio, a product that uses a device called an auto-injector to deliver controlled doses of naloxone into muscle tissue or into the tissue beneath the skin. Built into the auto-injector is a recorder than contains spoken instructions on how to safely administer the medication to someone who exhibits the symptoms of an opioid overdose. Critically, Evzio is available for use by the family members of known opioid addicts, as well as non-physicians who provide care for people affected by opioid addiction.


The FDA specifically notes that it approved Evzio out of awareness of the need for an opioid overdose treatment that can be used outside of a traditional medical setting involving doctors or trained emergency personnel. In order to get the medication on the market as quickly as possible, the agency relied on a special set of rules that allows for the rapid approval of medications that appear generally safe and have no effective equivalents currently available for use. While announcing the approval of Evzio, officials from the FDA urged the family members of opioid addicts and the people who work with those affected by opioid addiction to familiarize themselves with the medication in advance in order to reduce any possible risks for misuse in an emergency situation. A training device is included with each dose of Evzio for this purpose.