Pubdate: Fri, 04 Apr 2014
Source: Philadelphia Inquirer, The (PA)
Copyright: 2014 Philadelphia Newspapers Inc
Contact:  http://www.philly.com/inquirer/
Details: http://www.mapinc.org/media/340
Author: Melissa Healy, Los Angeles Times
Bookmark: http://mapinc.org/topic/naloxone
Bookmark: http://www.mapinc.org/find?132 (Heroin Overdose)

PUTTING OVERDOSE REVERSAL IN REACH

The FDA Approved a Device That Opioid Users' Family or Caregivers Can Use.

LOS ANGELES - With opioid drugs, mainly prescription painkillers, 
responsible for more than 16,000 deaths and half a million emergency 
room visits a year, the government on Thursday approved the sale of a 
handheld "rescue pen" that caregivers or family members can use to 
avert a potentially fatal overdose.

The Food and Drug Administration said it cleared the prescription 
auto-injector to deliver naloxone - the same non-narcotic drug that 
paramedics and ER doctors use - nearly three months ahead of schedule 
and after just 15 weeks of deliberation under so-called priority review.

The device, to be marketed under the commercial name Evzio and 
produced for the Richmond, Va., firm Kaleo Inc., is modeled on 
devices like those that deliver epinephrine to patients with ana 
phylactic reactions, or insulin to diabetics.

Like an automated external defibrillator, however, the Evzio kit also 
provides verbal instruction in the use of the injection for 
caregivers or family members who recognize the dangerously slowed 
heartbeat, depressed respiration and loss of consciousness that 
suggests someone taking opioids has overdosed. A training device 
allows caregivers and family members to practice emergency 
administration of 0.4 mg. of naloxone, which can be injected into 
muscle or just under the skin.

The device could not have saved Kacie Rumford, 23, who died of a 
heroin overdose, alone in her bedroom in the family's Kennett Square 
home on March 12, 2013. But opioid overdoses take hours to become 
fatal, and addicts often use together.

"If I had this I'd be walking around with this thing in my pocket," 
said Andy Rumford, who found his daughter on her bed, a needle next to her arm.

Making this product available for use beyond an ambulance or hospital 
"could save lives by facilitating earlier use of the drug in 
emergency situations," said Bob Rappaport, director of the division 
of anesthesia, analgesia, and addiction products at the FDA's Center 
for Drug Evaluation and Research.

How much it is used will depend to some extent on cost, which had not 
been determined, and whether health insurance will cover it.

The prescription painkiller epidemic spans all social classes, with 
the largest growth in recent years among white suburbanites. But it 
has spurred a parallel increase in heroin addiction, as users of 
pills require larger doses and discover that heroin is a fraction of 
the cost. The downward spiral of heroin addiction can leave users penniless.

The use of Evzio is not without risks. Among the opioid-dependent, a 
shot of naloxone can cause sudden and severe opioid withdrawal, which 
can cause nausea, vomiting, accelerated heart rate, increased blood 
pressure, seizures, and cardiac arrest. Repeat doses may be needed, 
as opioids can outlast naloxone's reversal effects, and the FDA 
cautioned that Evzio is not a substitute for emergency medical care.

But naloxone, also known by the brandname Narcan, is considered 
relatively safe and non-addicting. If it is mistakenly used to treat 
something other than an opioid overdose, experts say, it will have 
almost no effect at all. (Other medical treatment would be needed; 
regulators say people whose overdoses are reversed using naloxone 
also should get followup medical treatment.)

The FDA's approval of Evzio was billed by the agency Thursday as part 
of a two-pronged approach to addressing opioid drug abuse, an 
epidemic that has overtaken automobile crashes as the leading cause 
of injury death in the United States.

In recent years, the agency has sought to reduce the abuse potential 
of opioid analgesics and tightened rules on the prescribing of opioid 
pain relievers. But the FDA recently approved marketing of a new 
extended-release opioid painkiller, Zohydro, in a formulation that 
activists, emergency physicians, and the agency's own advisory panel 
have warned could be diverted and misused.

Such decisions, FDA Commissioner Margaret Hamburg said Thursday, aim 
to "ensure continued access to effective and appropriate medications 
for millions of Americans currently suffering from pain."

In a statement released alongside the approval of the naloxone 
rescue-injector, Hamburg called the goals of reducing opioid abuse 
while preserving patients' access to pain relief "compatible," and 
said that "actions to address one should not be at the expense of the other."

"While the larger goal is to reduce the need for products like these 
by preventing opioid addiction and abuse, they are extremely 
important innovations that will help to save lives," Hamburg said in 
a statement.
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MAP posted-by: Jay Bergstrom