White House Designates Veterinary Sedative As An “Emerging Drug Threat”

An increasingly common additive in illicit opioid supplies

Dr. Rahul Gupta, director of the White House’s Office of National Drug Control Policy (ONDCP), said he was “deeply concerned about what this threat [of xylazine] means for the nation,” citing its increased presence in supplies of fentanyl and involvement in a rising number of overdoses.^[1]

Xylazine is a non-opioid tranquilizer that has been authorized for use by veterinarians since the 1970s but has no approved human use. It first emerged as a drug of abuse, usually mixed with illicit opioid supplies, in the 2000s, initially in Philadelphia. 

Cheaper and easier to procure than many illicit opioids and known for enhancing highs, xylazine—known on the street as “tranq” or “tranq dope”—has spread rapidly across the country over the last few years

Citing data from the Drug Enforcement Administration (DEA) and Department of Justice, Dr. Gupta said that in just the two-year period from 2020 through 2021, the detection of xylazine at forensic labs spiked by 193% in the south and 112% in the west.^[2]

In March, the DEA reported that in 2022 it detected xylazine—not an officially scheduled substance—in 23% of confiscated fentanyl samples in 48 states.^[3] The substance has also turned up in supplies of amphetamines.        

Most of the xylazine found in the U.S. is believed to be illicitly imported, largely from China and possibly also Mexico, India, and Russia.^[4] However, law enforcement believe that some may be diverted from legitimate veterinary use and are working to identify these source.^[5]

Linked to deadlier overdoses and skin abscesses

ONDCP has moved against xylazine because of its unique risk profile, Gupta said. A non-opioid sedative, the drug causes respiratory depression, deep sedation, a slow heart rate, and low blood pressure. At high doses and combined with opioids, it can cause coma and death. 

Xylazine’s effects also can’t be reversed with standard rescue drugs such as naloxone, making overdoses deadlier. In 2020, the drug was detected in around 800 drug fatalities, primarily in the northeast. By 2021, there were more than 3,000 xylazine-positive overdose deaths, with a 1,127% increase in the South and 750% in the West.^[2]

“Many communities are not even aware of the threat in their backyard,” Dr. Gupta said.

Xylazine also reduces blood supply to the skin and can cause ulcers and accesses, especially when injected. Some users develop such severe infections and necrosis on their limbs they require amputation.

The withdrawal symptoms are so intense, Dr. Gupta noted, “that persons may leave medical treatment, including drug treatment, against medical advice.”^[4]

The administration will now develop a national strategy to combat xylazine

Fentanyl-laced xylazine is the first drug to be designated an “emerging threat” since the classification was established by a 2018 directive from Congress. The designation is intended to fast-track government response to rapidly-growing drug dangers, as measured by geographic spread and overdoses, among other metrics.^[6]

The ONDCP and wider Biden administration now have 90 days to outline a whole-of-government response to xylazine, including evidence-based prevention, treatment, and supply reduction.^[1]

This will likely include “rapid research" into the substance and its interactions with fentanyl; work to develop an antidote; expanded testing; creating protocols for treatment, withdrawal, and wound care; gathering further data, including about drug sourcing and supplies; and developing strategies to reduce the illicit supply.^[1,4]

Gupta said his office is requesting $11 million as part of its budget to develop a strategy for tackling xylazine’s spread.^[5]

Xylazine is poised to become a controlled substance

The ONDCP and the interagency working group it convenes will also consider whether Congress should classify the currently unscheduled drug as a controlled substance. 

Lawmakers have already been considering adding xylazine to the list of drugs restricted under the federal Controlled Substances Act. 

A bipartisan bill presented in both the House and Senate in March would make the drug a Schedule III substance. This would impose tougher penalties on dealers transporting and selling xylazine and require manufacturers to send reports on their production and distribution of the drug to the DEA in order to track and prevent diversion.^[7] The drug would continue to be available for legitimate veterinary use.

Meanwhile, Pennsylvania, ground-zero of the epidemic, this week moved to classify xylazine as a Schedule III controlled substance within its own borders.

“The steps we are taking today will help ensure this dangerous drug can't be diverted from legitimate sources to the drug dealers harming our communities, while preserving its important use on animals,” said Governor Josh Shapiro in a press conference.^[8]

Xylazine has been under mounting scrutiny from regulators and law enforcement in recent months. In November, the Food and Drug Administration (FDA) issued a national warning to healthcare professionals about the substance and in February moved to more closely scrutinize imports of it.^{[9, 10]}

In March, the DEA issued a public safety alert in response to “a sharp increase in the trafficking of fentanyl mixed with xylazine.”^[3]