Biden administration designates fentanyl laced with xylazine an ‘emerging threat’

Key takeaways:

• Xylazine-positive overdose deaths substantially increased in all Untied States regions from 2020 to 2021.
• Fentanyl laced with xylazine poses significant risks for fatal overdoses and morbidity.

The Biden administration has declared fentanyl laced or associated with xylazine as an “emerging threat” to the United States, the White House announced Wednesday.

It is the first time any administration has designated a drug as an evolving and emerging threat since Congress passed The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment Act in 2018, Rahul Gupta, MD, MPH, FACP, MBA, the director of the White House Office of National Drug Control Policy (ONDCP), said in a press release.

“As a physician, I am deeply troubled about the devastating impact of the fentanyl-xylazine combination,” Gupta said. “By declaring xylazine combined with fentanyl as an emerging threat, we are being proactive in our approach to save lives and creating new tools for public health and public safety officials and communities across the nation.”

The use of xylazine, a non-opioid tranquilizer approved for veterinary use but not for use in humans, has seen significant and deadly surges across all four regions of the U.S. in recent years. A U.S. Drug Enforcement Agency (DEA) intelligence report found that from 2020 to 2021, xylazine-positive overdose deaths increased by 750% in the West, 1,127% in the South, more than 500% in the Midwest and more than 100% in the Northeast.

In addition, from 2020 to 2021, laboratory identifications of xylazine increased in all four regions, most notably in the South, which experienced a 193% increase, and the West, with a 112% increase.

DEA Administrator Anne Milgram said in a press release that 23% of fentanyl powder and 7% of fentanyl pills that were seized by the DEA in 2022 contained xylazine.

For a drug to be reviewed as an emerging threat, its use must have risen at least 15% in three of the four U.S. regions, while the potential termination of a designation is only reviewed after a decrease of at least 15% in three of the four regions.

In addition to an increase in use, the Biden administration said the designation was given due to the combined drugs’ association with “significant and rapidly worsening negative health consequences, including fatal overdoses and severe morbidity.”

“Xylazine is making the deadliest drug threat our country has ever faced, fentanyl, even deadlier,” Milgram said.

According to the DEA, naloxone hydrochloride cannot reverse the effects of xylazine, but experts still recommend administering it to anyone suffering from drug poisoning. The DEA also noted that injections of xylazine can lead to serious wounds that may require amputation.

The ONDCP will now begin the development of a national response plan consisting of xylazine testing, treatment and support protocols, data systems on drug sources and supply, research on fentanyl-xylazine associations and strategies to reduce illegal xylazine supply, the White House said.

References:

• Biden-⁠Harris administration designates fentanyl combined with xylazine as an emerging threat to the United States. https://www.whitehouse.gov/ondcp/briefing-room/2023/04/12/biden-harris-administration-designates-fentanyl-combined-with-xylazine-as-an-emerging-threat-to-the-united-states/. Published April 12, 2023.
• Criteria for designating evolving and emerging drug threats. https://www.whitehouse.gov/wp-content/uploads/2023/01/Emerging-Threats-Criteria-Directive.pdf. Accessed April 13, 2023.
• DEA reports widespread threat of fentanyl mixed with xylazine. https://www.dea.gov/alert/dea-reports-widespread-threat-fentanyl-mixed-xylazine. Published April 13, 2023.
• The growing threat of xylazine and its mixture with illicit drugs. https://www.dea.gov/documents/2022/2022-12/2022-12-21/growing-threat-xylazine-and-its-mixture-illicit-drugs. Published Dec. 21, 2022. Accessed April 14, 2023.