New Easy-to-Use Opioid Overdose Treatment Device Approved by FDA
Posted by azdrugrehabctr on April 10, 2014 under Opiate Abuse | 
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A hand-held device, called Evzio, recently received approval from the Federal Drug Administration (FDA) and is expected to be available to the public this summer. The device is similar to an EpiPen used to stop allergic reactions, and is intended to be a life-saving treatment when administered during an overdose.
In a news release following approval, the FDA recommends that family members or caregivers become familiar with the instructions for use before administering Evzio. When the device is turned on, it gives verbal operating instructions to the user, similar to automated defibrillators that hang in public buildings.
The device is designed to deliver a single dose of the opioid overdose antidote, naloxone. The medication works by blocking the ability of heroin or opioid painkillers to attach to brain cells. The FDA notes that because naloxone may note work as long as opioids, repeat doses may be needed. The news release also states that users should seek immediate emergency medical care after administering the antidote.
“This is a big deal, and I hope it gets wide attention,” said Dr. Carl R. Sullivan III, Director of the Addictions Program at West Virginia University. “It’s pretty simple: Having these things in the hands of people around drug addicts just makes sense because you’re going to prevent unnecessary mortality.”
FDA officials say that they speedily approved the device in just 15 weeks because it is critical to prevent deaths by overdose, which have been on the rise despite the agency’s recent efforts. In the past year, the FDA has recommended tightening prescription practices and the changing of labeling requirements for opioid prescription drugs, although many experts believe these are just baby steps on the way to tackling the bigger issues.
“They’re plucking the low-lying fruit, but the hard things haven’t been done,” said Dr. Katz of Tufts University. FDA Commissioner, Dr. Margaret Hamburg, agrees with Dr. Katz’s suggestion to require doctors who prescribe highly addictive opioids to get training in how to do it properly. Such training is currently voluntary.
To address the concerns like those of Dr. Katz, Dr. Hamburg emphasized that “tackling the opioid epidemic is a high priority for the FDA,” according to the release. The FDA has made a point to be outspoken about it’s efforts to fight opioid abuse since receiving criticism last fall when it approved the powerful hydrocodone drug, Zohydro, against the advice of the expert panel.
Even though some are concerned that the existence of an overdose antidote will encourage drug users to be even more cavalier with their drug use, many are hopeful that the increased availability of the Evzio device will result in benefits that significantly outweigh the risks.
