WASHINGTON — In a move meant to prevent deaths caused by the nation's prescription drug epidemic, the Food and Drug Administration on Thursday approved a new device that would let family members or caregivers administer emergency medication to combat an overdose.
The product, Evzio, rapidly delivers a dose of naloxone, a drug that has long been used to reverse the effects caused by an overdose of a powerful class of painkillers known as opioids. The treatment would be administered through a handheld automatic injector that gives verbal instructions to the user and is small enough to carry in a pocket.
Federal officials fast-tracked approval of the sale of Evzio, by prescription, saying it could play a critically important role in preventing some of the 16,000 deaths per year attributed to painkiller abuse, a problem that has grown steadily worse in the past decade and now eclipses the number of people killed in car crashes. Because victims of opioid overdose tend to lose consciousness, allowing nearby family members or caretakers to administer naloxone outside a hospital setting could mean the difference between life and death for some patients.
Regulators warned Evzioshould not be considered a substitute for medical care.
"Until now, most people had to rely on emergency medical care to get access to an opioid reversal agent," Allen Burton, an anesthesiologist and pain specialist at Houston Pain Centers, said in a statement released by Kaleo, the maker of Evzio. "Having naloxone available for use by caregivers as soon as signs of overdose are observed means an earlier intervention and better chance of survival."