A device developed to save the lives of heroin addicts and other narcotic drug abusers is now being touted as a lifesaving treatment for pain patients who overdose on prescription opioids.
The Food and Drug Administration has approved a handheld injector called Evzio that delivers a single dose of the drug naloxone to people suffering from a potentially fatal overdose.
Family members and friends of drug addicts – or even patients taking opioids for a medical condition – are being encouraged to get the device and keep it at home as an emergency treatment for loved ones. The injector, which must be obtained through a prescription, can be carried in a pocket or stored in a medicine cabinet.
“A family member of someone at risk for opioid overdose could receive a prescription,” said Dr. Douglas Throckmorton, deputy director at the FDA’s Center for Drug Evaluation and Research. “Physicians can prescribe to anyone concerned about the risks of possible opioid overdose.”
Naloxone rapidly reverses the effects of a narcotic overdose – such as respiratory depression – which can cause someone to stop breathing or lose consciousness. However, existing naloxone drugs have to be injected with a syringe and are most commonly used by trained medical personnel in emergency departments and ambulances.
Evzio is designed to be used by lay people. Once turned on, Evzio provides verbal instructions on how to deliver the medication, similar to how an automatic heart defibrillator works.
“There was a great emphasis on making it very user-friendly, both the labeling information and the device itself,” said FDA commissioner Margaret Hamburg. “The last instruction the device gives is to call 911, because this product is not a substitute for emergency care.”
Drug overdose deaths are one of the leading causes of accidental death in the United States and the FDA is under increasing political pressure to combat what has been called an “epidemic” of prescription drug abuse. More than 16,000 Americans die each year from opioid overdoses, although in many cases alcohol or other drugs are involved.
“The FDA will continue to work to reduce the risks of abuse and misuse of prescription opioids,” said Hamburg.
“We know that the illegal diversion, misuse, and abuse of prescription opioids are often fueled by inappropriate prescribing, improper disposal of unused medications, and the illegal activity of a small number of health care providers. This highlights the important role that education of prescribers and patients can play in addressing this epidemic.”
The FDA fast-tracked the approval of Evzio in just 15 weeks under the agency’s priority review program.