Bio & Life Sciences Healthcare

FDA Approves Medical Device for Reversing Opioid Overdose

EvzioWhen mobster wife Mrs. Mia Wallace overdoses on heroin, hit man Vincent Vega brings her screaming out of a comatose state by jabbing an adrenaline-filled syringe into her heart.

Had the talking medical device that the FDA gave fast-track approval to last week existed 20 years ago, that Pulp Fiction scene between Uma Thurman and John Travolta might not have been so dramatic. The new pocket-sized naloxone hydrochloride auto-injector, called Evzio, coaches a user through the procedure of administering the opioid-O.D.-reversing drug into a victim’s muscle. FDA compares the device, available only by prescription, to using an epinephrine pen for severe allergic reactions with the coaching voice of an automated defibrillator. Device maker Kaleo Pharma of Richmond, Va., explains, “EVZIO uses voice and visual cues to assist in guiding a user through the injection process.”

Why the expedited government review of the technology? Death by opioid—largely due to overdoses of prescription pain meds such as OxyContin and Vicodin—has been increasing for more than a decade and has now surpassed motor vehicle crashes as the leading cause of injury death in the U.S., according to the Centers for Disease Control and the FDA. Driven by dependence on expensive prescription drugs, heroin use has also doubled since 2009. Last month, DEA Special Agent Jack Riley told BBC News that heroin addiction in the U.S. “is probably at its all-time high”now.

“Overdose and death resulting from misuse and abuse of both prescription and illicit opioids has become a major public health concern in the United States,” FDA’s Bob Rappaport, said in a statement. The director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research, Rappaport calls Evzio “the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a health care setting.”

Naloxone is not new. But until now, the drug was most commonly administered by trained medical personnel in emergency departments and ambulances.

FDA warns: “…use of Evzio in patients who are opioid dependent may result in severe opioid withdrawal. Abrupt reversal of opioid depression may result in nausea, vomiting, sweating, accelerated heart rate (tachycardia), increased blood pressure, uncontrollable trembling (tremulousness), seizures, and cardiac arrest.”

In other words, this DIY technology is no substitute for seeking treatment for a drug addiction.

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