The U.S. Food and Drugs Administration approved a device that will allow family and friends to treat any opioid overdose victim.
This is the first naloxone treatment specifically designed to be used by non medical individuals. The device named Evzio will automatically inject the right dosage of the overdose antidote. The FDA clarified that the device was only meant for emergency treatment of known or suspected opioid overdose characterized by decreased breathing or heart rate, or loss of consciousness.
"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," said Bob Rappaport, director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA's Center for Drug Evaluation and Research in a statement. "Evzio is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a health care setting. Making this product available could save lives by facilitating earlier use of the drug in emergency situations."
Deaths from drug overdose have been rising steadily over the past two decades in the United States. According to a CDC report, 38,329 people died from a drug overdose in the United States in 2010 and this number has been on the rise ever since.
Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for overdose. Current naloxone drugs are mostly used by trained medical personnel in emergency departments and ambulances.
A clinical study conducted on 30 individuals revealed that a single Evzio injection provides as much naloxone as does a standard syringe used by medical personnel. Abrupt use of the device may result in side effects like nausea, vomiting, sweating, accelerated heart rate (tachycardia), increased blood pressure, uncontrollable trembling (tremulousness), seizures and cardiac arrest.
The FDA also clarified that Evzio is not a substitute for immediate medical care. People administrating the device should be familiar with its functioning and should call for medical assistance on behalf of the opioid overdose victim, even after using Evzio.
Though the FDA has approved this easy-to-use injection device, Pennsylvania has not yet passed legislation that would allow the public to have access to the overdose antidote, naloxone, according to The Sentinel.
