White House designates xylazine as an 'emerging drug threat'

On Wednesday, the Biden administration designated xylazine — an animal tranquilizer that is commonly mixed with opioids — an "emerging drug threat" in the United States.

"This is the first time in a nation's history that a substance is being designated as an emerging threat by any administration," said ONDCP Director Rahul Gupta. "And it couldn't come at a more critical time."

While xylazine has been approved for veterinary procedures for decades, it has never been authorized for use in humans. The drug, which is commonly known as "tranq," is a highly addictive sedative that slows a user's breathing and heart rate, increases their risk of fatal overdose, and often causes skin ulcers and abscesses that can lead to amputations.

According to Gupta, tranq has "been increasingly found in [other] drugs, particularly in fentanyl. The DEA [Drug Enforcement Administration] reports that between 2020 and 2021, forensic identifications of xylazine rose in all four U.S. Census regions." Xylazine-positive overdose deaths have also increased all across the country.

In March, the DEA issued a  xylazine alert  saying it detected the drug in 23% of confiscated fentanyl samples from 48 states in 2022.

There are several key factors that led to ONDCP's designation. In particular, the agency highlighted the fact that conventional methods for reversing an opioid overdose, including naloxone injections or nasal sprays, may not be able to revive a person who has used xylazine.

In addition, Gupta noted that withdrawal symptoms are so severe that patients "may leave medical treatment, including drug treatment, against medical advice."

ONDCP's announcement follows an onslaught of warnings from local health authorities and other federal agencies. Last November, FDA  issued a nationwide warning to healthcare providers. Then, the agency announced plans to monitor imported xylazine for illegal use in February.

"As the president's drug policy adviser, I am deeply concerned about what this threat means for the nation," Gupta told reporters during a briefing call on Tuesday, later adding: "We must act and act now."

How the White House plans to address the threat

Under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, the White House must publish a "whole-of-government, nationwide plan" to address xylazine within 90 days, Gupta said.

While the White House has not published an official plan, Gupta outlined several steps in ONDCP's plan. To address the "emerging drug threat," ONDCP will work to improve:

Testing

"Many communities are not even aware of the threat in their backyard," said Gupta. "We need to increase the testing capacity as a nation and standardize practice for labs, medical examiners, and coroners. We also need to develop a point-of-care-style test usable for real-time testing and care."

Data collection  

"We need to develop a comprehensive data system updated regularly with the spread and impact of FAAX [fentanyl-adulterated or -associated xylazine] at the city, county, and state levels in order to inform both national and local response," and create a platform that mirrors the non-fatal overdose dashboard developed by ONDCP and its partners, he added.

Health interventions

"We will bring together national experts in the field to guide evidence-based practices to identify the most promising approaches in clinical stabilization, withdrawal management, and treatment protocols," Gupta said. "This includes addressing addiction to both fentanyl and xylazine in order to improve individuals' chances of recovery."

Targeting the supply of illicit xylazine

"We need public health and public safety officials to know more about the supply chain and also about how [xylazine] is being used in illicit drug markets throughout the United States," to help law enforcement officials find ways to disrupt the xylazine supply, he said. "We're also looking ahead to what will potentially come after xylazine as an additive to fentanyl in order to get in front of the next additive in the drug supply."

Regulation

"The federal government is going to look at whether scheduling makes sense -- either xylazine itself or the broader class of similar substances that can be used in place of xylazine as an adulterant to fentanyl," Gupta noted. "The administration will also work with Congress to evaluate options for scheduling changes for xylazine. At the same time, we also must maintain a legitimate supply of xylazine that is needed for veterinary medicine."

Research 

"We need an approved xylazine antidote and to determine the best possible treatments for it, including culturally competent and equitable care," he said. "We need to better understand this drug's effect on people based on the mode of administration, what reduction strategies could be helpful, best practices for supporting recovery from xylazine use, and how fentanyl combined with xylazine during pregnancy will affect it." (Frieden, MedPage Today, 4/12; Hoffman, New York Times, 4/12; Facher, STAT, 4/12; Arkin, NBC News, 4/12)

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