FDA approves home-use auto-injector to treat opioid overdoses


In April, the US Food and Drug Administration (FDA) approved the first home-use naloxone auto-injector, Evzio (Figure 1), for people who accidentally overdose on an opioid (narcotic). The lifesaving auto-injector allows you or a family member to quickly inject the medicine to temporarily reverse the effects of an opioid overdose until emergency medical assistance is available. The medicine can be given to an adult or a child.

According to FDA, drug overdoses, caused mostly by prescription drugs, are the leading cause of death in the US among people ages 25 to 64, even more than car accidents. In a 2013 report by the Centers for Disease Control and Prevention (CDC), opioid overdoses lead to an estimated 16,000 deaths in the US per year. Examples of opioids and products that contain opioids involved in overdose deaths include morphine (e.g., Kadian, Avinza, MS Contin), oxycodone (e.g., Percocet, OxyContin), hydrocodone (e.g., Vicodin), methadone, fentanyl, hydromorphone, codeine, and street drugs such as heroin.

About naloxone

The medicine in the Evzio auto-injector is naloxone. This medicine rapidly reverses the effects of opioids. It is the same medicine given to opioid overdose victims by trained ambulance responders, and nurses and doctors in the emergency department. Evzio is the first drug available in an auto-injector to treat opioid overdoses so it can be given outside the hospital by family members, caregivers, or friends in an emergency. Naloxone was previously available for use outside of hospitals only in kits that contain vials of the medicine and syringes. Training was required to learn how to draw the medication dose into a syringe and inject it properly. But making the medicine available in an auto-injector for easy use could save many lives. Unfortunately, the medicine is not effective for the treatment of other drug overdoses—it only treats opioid overdoses.

Evzio is not a substitute for emergency medical care. Once the medicine has been injected, emergency medical assistance should be initiated immediately. One reason that emergency follow-up care is necessary is that opioids often last longer in the body than naloxone. So, the naloxone will wear off, and the opioids could cause life-threatening symptoms that may require a second dose of naloxone. If available, repeated doses of Evzio may be needed every 2 to 3 minutes while awaiting emergency medical assistance.

In addition, symptoms of severe opioid withdrawal can occur. Because naloxone abruptly reverses the effects of opioids, an overdose victim may experience withdrawal symptoms, including nausea, vomiting, body aches, fever, sweating, shivering, restlessness, irritability, fast heart rate, high blood pressure, uncontrollable trembling, seizures, and the heart may stop beating. These symptoms will be most severe in overdose victims who are addicted to or dependent on opioids.

About the auto-injector

Evzio comes in a hand-held auto-injector that requires minimal training to use. When you turn on the device, evizio imageit gives verbal instructions on how to inject the medicine into the muscle or under the skin (subcutaneous). You simply pull off a red safety guard, place the black end of the device on the outer thigh (over clothing, if necessary), press firmly, and hold in place for 5 seconds. The device flashes a green light when the injection is ready and a red light when the dose has been given. The Evzio auto-injector contains a single dose of the medicine and cannot be reused. Verbal instructions remind the user to seek immediate medical treatment, and to bring the used auto-injector to the emergency care provider for proper disposal.

Family members should become familiar with the auto-injector and how to use it in an emergency. A video regarding proper use is available on the Evzio website. A trainer auto-injector device that does not contain the actual medicine is included for practice when you purchase Evzio. 

When to treat

Evzio should be administered when an overdose with opioids is suspected or known. Overdoses are most common when taking more than one opioid, when taking these drugs while alone, and when taking these drugs after long periods of non-use. The signs of an opioid overdose include:

• Slow and shallow breathing, snoring, gasping, or gurgling sounds
• Low heart rate and low blood pressure
• Mental confusion, slurred speech, or loss of consciousness
• Intoxicated behavior
• Pale face, blue cast or ashen lips and nails
• Pinpoint (very small) pupils
• Clammy skin
• Vomiting

If you think someone has overdosed on an opioid but are not certain, you should still give Evzio. Naloxone will not injure a person who has not overdosed on an opioid.

Legal concerns

The chance of surviving an opioid overdose depends on how fast one receives medical assistance. Thus, many opioid overdose deaths could be prevented if naloxone is administered and emergency medical assistance is immediately summoned. However, people who have taken a prescription or street opioid illegally and those who witness an overdose from illegal drugs may fear arrest if they call for help. In fact, research confirms that the most common reason for not calling for medical help is fear of police involvement.1

To encourage those who overdose or witness an overdose to seek medical help, laws that protect them from arrest and prosecution for minor drug (and alcohol) law violations have been enacted in the District of Columbia and 15 states including: California, Colorado, New Jersey, New Mexico, New York, Rhode Island, Illinois, Florida, Massachusetts, Connecticut, North Carolina, Vermont, Delaware, Washington, and Georgia. Often called the "Good Samaritan 911 laws," these laws do not protect people from arrest for other offenses, such as selling or trafficking drugs, or driving under the influence of drugs. But they do protect the person who calls for help and the overdose victim from arrest and/or prosecution for simple drug possession, possession of drug paraphernalia, and/or being under the influence of an illegal drug.

Now available

Evzio is now available with a prescription. While the ultimate goal is to prevent opioid addiction, abuse, and overdoses in the first place, Evzio is an important innovation that will help save lives right now.


1. Tracy M, Markham Piper T, Ompad D, et al. Circumstances of witnessed drug overdose in New York City: implications for interventions. Drug and Alcohol Dependence. 2005;79:181-90.


Created on July 23, 2014

Medication Safety Alerts

FDA Safety Alerts

Show Your Support!

ISMP needs your help to continue our life saving work