U.S. Attempts to Get Its Xylazine Problem Under Control

— If a bill to schedule the veterinary sedative becomes law, will that be enough?

by
Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today
December 30, 2023

In February, we reported on the emerging problem of xylazine-laced fentanyl. In this report, we follow up on what has happened since doctors first started raising concerns about this contaminant and its effects.

Early in 2023, word started to spread among physicians that a veterinary tranquilizer called xylazine — also known as “tranq” — was being added to fentanyl sold on the streets, to boost the opioid’s effects and extend its high.

Xylazine’s complications were startling — particularly the necrotizing wounds that would affect injection drug users. These often required extensive treatment, and sometimes, amputation.

“We’ve been doing a lot more amputations over the last couple of years for really bad necrotic wounds and dysfunctional limbs and infections that go all the way down to the bone,” Philadelphia emergency medicine physician Joseph D’Orazio, MD, told MedPage Today at the time.

Since that time, regulators and lawmakers — including the FDA, the White House Office of National Drug Control Policy (ONDCP), and Congress itself — have launched a host of efforts to bring the xylazine problem under control.

In late February, the FDA implemented an import alert on xylazine that allowed its staff to detain shipments of any xylazine product that “appears to be in violation of the law.” During xylazine entry reviews, FDA staff would work to ensure the product is properly labeled, not adulterated, and legitimate for veterinary use, the agency announced.

Then, in April, the ONDCP proclaimed xylazine-tainted fentanyl an “emerging drug threat” in the U.S. that requires immediate action — a national first for any substance.

The agency followed up its tough talk in July by publishing a National Response Plan to coordinate a “whole-of-government response” against xylazine-laced fentanyl. The plan contained several strategies, including testing for xylazine by users and law enforcement, improving data collection on its use, disrupting the supply chain, and exploring regulatory options under the Controlled Substances Act.

ONDCP also asked the Drug Enforcement Administration (DEA) and the Department of Homeland Security to provide an update on the sources of illicit xylazine, which the agencies reported in September as coming “in solid form from China and other countries, in liquid form either diverted from veterinary supply chains or packaged to resemble a veterinary drug, and, to a lesser degree, mixed with fentanyl seized at the southwest border.”

Most recently, on December 12, the House of Representatives passed the Support for Patients and Communities Reauthorization (SUPPORT) Act of 2023 by a vote of 386 to 37.

The bill, also known as H.R. 4531, includes a provision to permanently place xylazine in Schedule III of the Controlled Substances Act, while maintaining access for veterinarians and ranchers to use in animals. It also contains a handful of other substance abuse-focused provisions, including fentanyl education for first responders, and guaranteeing that Medicaid beneficiaries have access to medication-assisted treatment.

The American Veterinary Medical Association (AVMA) praised the bill, with president Rena Carlson, DVM, saying in a statement that the group “applauds and fully endorses the xylazine language included in the SUPPORT Act passed by the House.”

“This language will help equip law enforcement with the tools necessary to combat illicit xylazine while preserving its legitimate and vital use within veterinary medicine as an animal sedative,” Carlson continued in the statement. “We are grateful to House and Committee leadership for their support on an issue that is critical to our profession. The AVMA is committed to continuing its work with lawmakers and staff to address this emerging public health threat while maintaining veterinary access to xylazine.”

But Andrew Kolodny, MD, an expert in opioid policy and addiction medicine at Brandeis University in Waltham, Massachusetts, expressed cautions around the veterinary industry potentially working too closely with Congress.

“The way it’s supposed to work is that a molecule gets scheduled, and that it makes no difference whether or not the molecule is manufactured licitly or illicitly,” Kolodny told MedPage Today. “It sounds to me like xylazine manufacturers, distributors, and vets will be exempt from all the laws that apply to Schedule III drugs, including tracking and storage requirements.”

There are two paths to scheduling a controlled substance. Either Congress acts or the FDA and the DEA work together to schedule the substance. Back in early February, MedPage Today reported that the DEA had conducted an “8-factor analysis” for xylazine, which is a necessary component of the DEA-FDA scheduling pathway. At that time, the AVMA also said it was “closely engaged with the relevant Congressional offices and committees” that were discussing scheduling xylazine.

It remains to be seen whether the SUPPORT Act will pass the Senate. In the meantime, trying to quantify the country’s xylazine-laced fentanyl problem is difficult, as there’s no national tracking system for xylazine-positive overdose deaths; not all jurisdictions routinely conduct testing for xylazine in postmortem toxicology, the DEA has said.