Pubdate: Fri, 04 Apr 2014
Source: Los Angeles Times (CA)
Copyright: 2014 Los Angeles Times
Contact:  http://www.latimes.com/
Details: http://www.mapinc.org/media/248
Authors: Melissa Healy, and Lisa Girion
Bookmark: http://mapinc.org/topic/naloxone
Bookmark: http://www.mapinc.org/find?132 (Heroin Overdose)

A DEVICE TO CURB DEADLY OVERDOSES

The FDA Approves the Sale of a 'Rescue Pen' To Reverse the Effects of 
Painkillers.

Federal officials said Thursday they hoped a new "rescue pen" would 
help reduce the death toll from overdoses involving prescription painkillers.

The Food and Drug Administration approved the sale, by prescription, 
of the prefilled auto-injector of the drug naloxone that caregivers 
or family members can use to reverse the effects of prescription 
painkillers, such as OxyContin and Vicodin, and heroin.

Available until now only by syringe, naloxone has been a workhorse 
drug in emergency departments battling the relentless rise in 
painkiller overdoses over the last decade. Some communities also have 
experimented with making naloxone available as a nasal spray to first 
responders, such as paramedics and police officers.

But the FDA's blessing of the rescue pen, granted after a 
fast-tracked deliberation of just 15 weeks, marks the first time the 
medication will be available on a broad basis in a prefilled 
hand-held auto-injector that can be used by laypeople.

"Today's announcement will help make naloxone even more accessible," 
Michael Botticelli, acting director of President Obama's Office of 
National Drug Control Policy, said in a telephone conference with 
physicians, researchers and public health advocates to promote the 
use of the rescue pen.

A huge increase in the use of narcotic painkillers has been 
accompanied by a rise in addiction and overdoses, which are now 
responsible for more than 16,000 deaths each year. The surge in 
painkiller-involved overdoses has pushed drugs ahead of traffic 
accidents as a leading cause of death in the U.S. and prompted the 
U.S. Centers for Disease Control and Prevention to declare the 
problem an epidemic in 2011.

The rescue pen is part of a widespread campaign by public health 
officials, healthcare professionals and the pharmaceutical industry 
to find ways to promote the safe use of the drugs and reduce deaths.

A 2012 Times investigation of nearly 4,000 deaths involving 
prescription drugs in Southern California found that most victims 
overdosed at home, often with family members or friends nearby.

The rescue pen, to be marketed under the commercial name Evzio by the 
Richmond, Va., firm Kaleo Inc., is modeled on devices such as those 
that deliver epinephrine to patients with anaphylactic reactions, or 
insulin to diabetics. It delivers 0.4 milligrams of naloxone, which 
can be injected into muscle or just under the skin. Like an automated 
external defibrillator, the Evzio kit also provides instructions.

Physicians who prescribe the pen can train caregivers and family 
members to recognize the dangerously slowed heartbeat, depressed 
respiration and loss of consciousness that suggests someone taking 
opioids has overdosed. The Times' examination of hundreds of 
coroners' reports found that loved ones often reported signs of an 
impending overdose, such as hearing an unusually loud snore from victims.

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 Dr. Bob Rappaport, director of the 
division of anesthesia, analgesia and addiction products at the FDA's 
Center for Drug Evaluation and Research.

The use of Evzio is not without risks. Among the opioid-dependent, a 
shot of naloxone can prompt 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. In fact, officials noted, the 
last instruction the pen gives is to call for medical help.

The FDA's approval of Evzio was billed by the agency Thursday as part 
of a multipronged approach to address painkiller addiction and overdose.

In recent years, the agency has sought to reduce the abuse potential 
of narcotic painkillers, also known as opioid analgesics, and 
tightened prescribing rules. However, 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 briefing, Hamburg called the goals of reducing opioid abuse 
while preserving 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," she said.
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MAP posted-by: Jay Bergstrom