Antidote for Prescription Painkiller Overdose OK'd
Evzio is part of efforts to stem health risks from abuse of drugs such as Oxycontin, Vicodin
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"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.