FDA Approves Portable Device to Reverse Opioid Overdose, Can be Used by Family Members and Caregivers

The U.S. Food and Drug Administration (FDA) recently announced their approval of a hand-held auto-injector device designed to reverse opioid overdose, whether the overdose is known or even suspected. The device is the first of its kind and can be given to the individual in need by family members or caregivers; a medical professional is not required to assist.

According to a press release on the FDA web site, “Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet.” It’s given to a person one of two ways: either injected subcutaneously (under the skin) or intramuscularly (directly in the muscle).

In a similar fashion to automated defibrillators, the device prompts users how to deliver the medication. Still, the FDA encourages family members and caregivers to become familiar with how it works and even suggests that they ” . . . practice with the trainer device, which is included along with the delivery device, before it is needed.”

The steady increase of drug overdoses in America over the past decade seems to have been a push in the development of this device. Bob Rappaport, M.D., a director at one of the divisions in the FDA’s Center for Drug Evaluation and Research explains that “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.”

The good and bad of this portable drug overdose device

Many people, like Dr. Carl R. Sullivan, director of the addictions program at West Virginia University, feel that Evzio is a good idea. “Many people OD and die from opioids because naloxone is not immediately available to reverse the OD effects. I cannot really see a downside.”

Using this device can reverse the effects of an overdose for approximately 10 minutes. That timeframe is ” . . . long enough to get someone to hospital instead of watching them die in front of you,” said Dr. Norm Buckley, the Director of Hamilton Health Science’s pain clinics.

Yet others beg to differ, saying that the device offers a false sense of hope and even encourages increased misuse of drugs. James Rathmell, chief of the division of pain medicine at Massachusetts General Hospital, says people may think, “‘O.K., I’ve got a naloxone pen, we can party all we want, no one is going to die.'” His “pen” reference stems from the fact that many media are dubbing the device “an Epipen for addicts.”

It’s anticipated that Evzio will be available this summer through all major pharmacies as well as by mail order with a prescription from a healthcare professional.

Sources for this article include:

http://www.nytimes.com

http://www.fda.gov

http://www.cbc.ca

http://www.wellness.com

http://finance.yahoo.com

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