FDA OKs quick-acting antidote for prescription painkiller overdose (Update)

April 3, 2014 by Dennis Thompson, Healthday Reporter
FDA OKs quick-acting antidote for prescription painkiller overdose
Evzio is part of efforts to stem health risks from abuse of drugs such as Oxycontin, Vicodin.

(HealthDay)—People suffering a potentially fatal narcotic overdose now can receive lifesaving treatment from folks around them, using a new device just approved by the U.S. Food and Drug Administration.

Evzio is a hand-held auto injector that delivers a single dose of the drug naloxone into the muscle or beneath the skin. The injector can be carried in a pocket or stored in a medicine cabinet and is meant as an emergency treatment for people who have suffered a known or suspected overdose of powerful pain drugs called opioids.

Opioids include prescription narcotic painkillers such as Oxycontin, Vicodin and Percocet—all of which have shown increasing rates of abuse in recent years.

They also include the illicit drug heroin, which has increased in popularity and recently led to the death of actor Philip Seymour Hoffman.

The Obama administration is urging all local police and fire departments to equip their officers and vehicles with Evzio, Michael Botticelli, acting director of the White House Office of National Drug Control Policy, said at a Thursday news conference.

Family members and friends of people who are struggling with narcotics addiction or are taking opioids for a medical condition also will be able to equip themselves with Evzio, just by getting a prescription from their physician.

"A family member of someone at risk for opioid overdose could receive a prescription," said Dr. Douglas Throckmorton, deputy director for regulatory programs at the FDA's Center for Drug Evaluation and Research. "Physicians can prescribe to anyone concerned about the risks of possible opioid overdose."

The product is built to be simple and easy-to-use for lay people, FDA Commissioner Dr. Margaret Hamburg said at the news conference.

Naloxone rapidly reverses the effects of overdose and is the standard treatment in such cases. However, current naloxone drugs have to be injected with a needle and their use is typically limited to trained medical personnel, the FDA explained.

Once the device is turned on, it provides verbal instructions on how to deliver the medication, similar to how an automatic heart defibrillator works.

"There was a great emphasis on making it very user-friendly, both the labeling information and the device itself," Hamburg said.

She added that "the last instruction the device gives is to call 911, because this product is not a substitute for emergency care."

The product's simplicity is partially aimed at encouraging police officers to equip and use Evzio, Botticelli said. Officers have been reluctant to administer naloxone injections, and also have been slow to adopt nasal inhalant forms of the medication because overdose treatment is an off-label use, the health officials said.

"We know that the men and women in law enforcement believe that saving a life is more important than making an arrest," Botticelli said.

More than 16,000 people die each year due to opioid-related overdoses, according to the FDA. Drug overdose deaths—driven largely by prescription drug overdose deaths—are now the leading cause of injury death in the United States, surpassing motor vehicle crashes.

The FDA fast-tracked the approval of Evzio, turning the application around in just 15 weeks, Throckmorton said.

The agency noted that repeat doses may be needed because naloxone may not work as long as opioids. Also, people who receive a shot of Evzio may experience "severe opioid withdrawal," the agency added.

There are dangers with quick withdrawal from "opioid depression," the FDA said, with symptoms such as nausea, vomiting, sweating and accelerated heart rate, as well as a risk for spikes in blood pressure, seizures and even cardiac arrest.

Obama administration officials took pains to place the approval of Evzio in the context of other efforts that are being taken to rein in prescription drug abuse, including:

  • Counseling physicians and pharmacists on ways to detect "doctor-shopping" and patients with a drug problem.
  • Advancing development of new non-opioid pain medications.
  • Further restricting the prescription of medications containing hydrocodone by rescheduling them from Schedule III to Schedule II.

Federal officials are tackling this issue while also weighing the needs of people who rely on these pain medications, said U.S. Department of Health and Human Services Secretary Kathleen Sebelius.

"When addressing the opioid problem, it is important we consider those who rely upon and appropriately use their medication," Sebelius said.

Explore further: Heroin antidote stirs debate in US as deaths rise

More information: The U.S. National Institute on Drug Abuse has more about opioids.

Related Stories

Heroin antidote stirs debate in US as deaths rise

February 27, 2014
(AP)—As deaths from heroin and powerful painkillers increase throughout the U.S., governments and clinics are working to put a drug that can reverse an opiate overdose into the hands of more paramedics, police officers ...

US: Heroin an urgent 'public health crisis'

March 10, 2014
U.S. Attorney General Eric Holder on Monday called an increase in heroin-related deaths an "urgent and growing public health crisis" and said first responders should carry with them a drug that can reverse the effects of ...

Changing laws, attitudes of police response to drug overdose may lead to better outcomes

September 26, 2013
A recent study from Rhode Island Hospital has found that a change in the way police respond to drug-related overdose emergencies could contribute to improved outcomes of the victims and to the communities where overdoses ...

3Qs: Access expands to opioid overdose antidote

March 6, 2014
Drug overdoses are reportedly on the rise both locally and nationally. The Massachusetts State Police has reported 185 fatalities since Nov. 1, which doesn't include the large cities of Boston, Springfield, and Worcester. ...

Report analyzes drug overdose morbidity and mortality among Kentucky residents

February 21, 2014
A new report from the Kentucky Injury Prevention and Research Center (KIPRC) reveals the prevalence and charges associated with drug overdose in the Bluegrass state. The report, "Drug Overdose Deaths, Hospitalizations, and ...

US officials target escalating drug overdoses

February 11, 2014
(HealthDay)—As deaths from heroin and prescription painkillers mount across the United States, government officials are searching for ways to stem the toll of addiction.

Recommended for you

Opioids overused in migraine treatment, regardless of race, study finds

August 17, 2017
African-Americans are more likely to experience debilitating migraine headaches than whites, but a new study probing the issue found no evidence of racial disparities in treatment practices.

Finding better ways to reduce serious drug side effects

August 14, 2017
Many of the medicines we depend on to treat disease—and even to save our lives—pose potentially serious risks along with their benefits. Data from the U.S. Centers for Disease Control and Prevention indicate that about ...

Ultrasound-triggered liposomes for on-demand, local anesthesia

August 10, 2017
Researchers at Boston Children's Hospital have found a new way to non-invasively relieve pain at local sites in the body; such systems could one day improve pain management by replacing addictive opioids and short-lasting ...

Independent pharmacies and online coupons help patients save money on drugs

August 8, 2017
Uninsured patients or those with limited prescription drug coverage can save significant money by buying their drugs at independent pharmacies instead of big box, grocery or chain drug stores and by using discount coupons, ...

New study generates more accurate estimates of state opioid and heroin fatalities

August 7, 2017
Although opioid and heroin deaths have been rising dramatically in the U.S., the magnitude of the epidemic varies from state to state, as does the relative proportion of opioid vs heroin poisonings. Further complicating the ...

Mind-body therapies immediately reduce unmanageable pain in hospital patients

July 25, 2017
Mindfulness training and hypnotic suggestion significantly reduced acute pain experienced by hospital patients, according to a new study published in the Journal of General Internal Medicine.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.