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Fentanyl adulterated with xylazine is an "emerging drug threat" in the U.S. and requires immediate action, the Biden administration warned.

"This is the first time in a nation's history that a substance is being designated as an emerging threat by any administration," said Rahul Gupta, MD, director of the White House Office of National Drug Control Policy (ONDCP), during a phone call with reporters late Tuesday afternoon. "And it couldn't come at a more critical time."

Xylazine was approved by the FDA for veterinary use in 1932, "but it was never approved for human use," Gupta said. "It's 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, most notably in the South by almost 200% and the West by over 100%. The DEA also reports that xylazine-positive overdose deaths increased more than 1,000% in the South, 750% in the West, and more than 500% in the Midwest, as well as more than 100% in the Northeast."

The consequences of xylazine use can be severe, he added. "Its use, witting or unwitting, can result in serious and life-threatening effects, including death. A powerful sedative, xylazine slows breathing and heart rate, lowers blood pressure to unsafe levels, and complicates efforts to reverse opioid overdoses with naloxone. It produces deep flesh wounds in users that require extensive medical intervention and often admission to the intensive care unit. And it can also lead to amputation of limbs."

Withdrawal symptoms are so severe that patients "may leave medical treatment, including drug treatment, against medical advice," Gupta added.

Under the signed by President Trump in 2018, if a drug is designated as an emerging threat, the administration has 90 days to develop a plan to combat it. On the phone call, Gupta outlined ONDCP's plan, which includes:

• 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. "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 post something similar to the that the ONDCP and its partners have developed, he said.
• 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," said Gupta. "This includes addressing addiction to both fentanyl and xylazine in order to improve individuals' chances of recovery."
• Attacking 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," so law enforcement officials can figure out how 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 continued. "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."

Andrew Kolodny, MD, an expert in opioid policy and addiction medicine at Brandeis University in Waltham, Massachusetts, praised these actions as a good first step but said they weren't enough. "It's great that he's taking the problem seriously and those sound like helpful interventions he's proposing, but first and foremost we should rely on existing systems for controlled drugs, which is scheduling," Kolodny said in a phone interview, adding that there is "overwhelming evidence" that the drug should be scheduled both nationally and internationally. "That's going to have a much greater impact."

Scheduling xylazine nationally will help because it will mean the DEA's scheduling regulations will be enforced for a drug that in its liquid form is currently being diverted from veterinary practices, he explained. "That means it would have to be tracked, and before [a distributor] could send a shipment, they would have to monitor for suspicious orders." If that had been done earlier, "when we started to see an uptick in orders, it could have been stopped."

International scheduling would help curb the online trafficking in xylazine powder, Kolodny said. "Any kind of scheduled drug is much harder to order online ... Once it's internationally scheduled, we're much less likely to see that."

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