FDA Gives OK to Heroin/Painkiller Overdose Antidote

FDA Gives OK to Heroin/Painkiller Overdose Antidote

April 7th, 2014 // 11:42 am @

Last week, FDA

approved a device on Thursday that reverses the effects of overdoses from opioids, including heroin and prescription painkillers.

Called Evzio, the injection-style device administers the drug naloxone.

Naloxone has long been used in ambulances and emergency rooms to treat opioid overdoses. Now Evzio allows caregivers, family members and non-medical personnel to keep naloxone on hand, according to the FDA. The device requires a prescription.

Evzio is injected into the muscle or under the skin. When the device is turned on, verbal instructions tell the user how to deliver the medication.

Naloxone is effective because it reverses the slowed-down breathing that leads to death during an overdose, writes Douglas Throckmorton, deputy director for regulatory programs with the FDA’s Center for Drug Evaluation and Research, in ablog post.

If someone is given naloxone who is not overdosing from an opioid, the dose available in the Evzio device will not hurt them, Throckmorton said in a press call.

However, Evzio is not a substitute for immediate medical care, the FDA says.

Calling products like Evzio “extremely important innovations that will help to save lives,” FDA Commissioner Margaret Hamburg, in a statement, added that the broader aim remains to reduce opioid abuse.

More than 16,000 people died in 2010 due to opioid-related overdoses, driven largely by prescription drug overdoses, according to the most recent year for which data was available, according to the Centers for Disease Control and Prevention.

One concern around the availability of this device is some people might feel encouraged to experiment with higher doses of opioid.

“There are risks and benefits to all medications,” said Eric Strain, director of the Johns Hopkins Center for Substance Abuse Treatment and Research. But, he added, “in the big scheme of things, this is probably a valuable tool, especially if it’s used and provided in the context of improving access to treatment.”

Robert Shesser, chair of the Department of Emergency Medicine at George Washington University, likened the device to a needle-exchange program.

“You can’t stop people from doing it, but you might as well give them a clean needle,” he said.

Shesser said that whether the overdose is from a prescription drug or an illegal drug like heroin, “having these auto-injectors out there is going to save lives, for sure.”

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