Toxicology labs and pain management providers should be on alert for the combination of fentanyl and xylazine after the White House recently designated the mixture of these drugs as an emerging threat to the United States.

Xylazine, also known as tranq or tranq dope, is a non-opioid tranquilizer approved by the Food and Drug Administration (FDA) for veterinary use but not human use. This unique designation as an emerging threat comes after a review of the impact of xylazine on the opioid crisis, including its growing role in overdose deaths in every region of the United States, according to Dr. Rahul Gupta, Director of the White House Office of National Drug Control Policy (ONDCP).

The Drug Enforcement Administration (DEA) reports xylazine combined with fentanyl is being sold illicitly and is associated with significant and rapidly worsening negative health consequences, including fatal overdoses and severe morbidity. Xylazine can also do major damage to the human body, including leaving users with severe skin ulcers, soft-tissue wounds, and necrosis.

• Between 2020 and 2021, forensic laboratory identifications of xylazine rose in all four U.S. census regions, with xylazine-positive overdose deaths increasing by 1,127% in the south, 750% in the west, more than 500% in the Midwest, and more than 100% in the northeast, according to the Biden Administration.

In March, authorities at the DEA issued a public safety alert about the “widespread threat” of fentanyl mixed with xylazine, reporting that in 2022 approximately 23% of fentanyl powder and 7% of fentanyl pills seized by the DEA contained xylazine.

Administration officials call the threat FAAX, for fentanyl-adulterated or -associated xylazine. This marks the first time in US history that any administration has declared a substance to be an emerging threat to the country.

 

How labs can respond to combat this crisis

In response to this emerging threat, Lighthouse Lab Services has developed a method and successfully completed validation. The method is ready to be customized at your site, giving labs the ability to test for this analyte and help better monitor the use and spread of the drug combination. Our senior laboratory data validation scientists are available to draft a validation plan, oversee the running of the validation samples, perform the necessary data analysis on the results, and compile it into a CLIA-compliant validation summary.

Additionally, the ONDCP is convening an interagency working group to inform the development of a national response plan. The response will include work on xylazine testing, treatment and supportive care protocols, comprehensive data systems (including information on drug sourcing and supply), strategies to reduce illicit supply of xylazine, and rapid research (such as work on the interactions between xylazine and fentanyl).

US lawmakers are also moving to classify xylazine as a controlled substance.

In March, bipartisan legislation – the Combating Illicit Xylazine Act – was introduced in the House and Senate. It describes the human use of xylazine as an “urgent threat to public health and safety” and calls for it to be a Schedule III drug under the Controlled Substances Act, a category on the five-level system for substances with moderate to low potential for physical or psychological dependence. Xylazine would be one level below opioids like fentanyl.

If you’re interested in learning more about our validation or would like to develop new methods to detect other emerging synthetic drugs and broaden your test menu, don’t hesitate to reach out to us directly to schedule a free consultation.