Skip to main content
Report this ad

See also:

FDA approves hand-held naloxone auto-injector to reverse opioid overdose

FDA Commissioner Margaret A. Hamburg

According to the CDC, drug overdose deaths have surpassed car crashes as the number 1 leading cause of injury death in the United States, surpassing motor vehicle crashes, with more than 16,000 fatalities due to opioid-related overdoses annually. This crisis has been “driven by the illegal diversion, misuse, and abuse of prescription opioids are often fueled by inappropriate prescribing, improper disposal of unused medications,” noted FDA Commissioner Margaret Hamburg upon announcing her agency’s approval of Evzio, an emergency treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose.

Available only by prescription, Evzio delivers a single dose of the drug naloxone injected into the muscle or under the skin to quickly reverses the effects of opioid overdose. The hand-held auto-injector can be easily kept in a pocket or stored in a medicine cabinet.

Once activated, the device uses verbal instruction to describe how to deliver the medication, similar to automated defibrillators. Family members or caregivers should become familiar with all instructions for use before administering to known or suspected persons to have had an opioid overdose.

“For more than a decade, the U.S. Food and Drug Administration has been working to address the important public health problems associated with the misuse, abuse, addiction and overdose of opioid analgesics, while at the same time working to ensure continued access to effective and appropriate medications for millions of Americans currently suffering from pain. I firmly believe that these goals are compatible, and that actions to address one should not be at the expense of the other,” stated Hamburg.

“The FDA will continue to work to reduce the risks of abuse and misuse of prescription opioids, but we cannot solve this complex problem alone. A comprehensive and coordinated approach is needed; one that includes the White House Office of National Drug Control Policy, the Drug Enforcement Administration and many of our sister agencies within the Department of Health and Human Services, as well as state and local governments, public health experts, health care professionals, addiction experts, researchers, industry, and patient organizations.”

Report this ad