A little-known animal tranquilizer is accelerating the deadly US opioid epidemic, frustrating health officials and lawmakers, who can’t keep the drug out of people’s hands.
The sedative, called xylazine, was implicated in more than 3,000 overdose-related deaths in the US in 2021, likely an undercount, health officials say. In the same year more than a third of overdose deaths in such heavily affected areas as Philadelphia involved the drug, usually in combination with fentanyl. Regulators are scrambling to track down its source while doctors search for ways to treat affected patients.
Xylazine is dangerous in so many ways: It constricts blood vessels, which can facilitate severe wounds that sometimes lead to limb loss; it can lethally depress breathing and blood pressure. This sedative isn’t an opioid, so first responders can’t depend on agents such as naloxone to block its effects. Last month the White House designated its combination with fentanyl an emerging threat and convened an interagency working group to develop a national response.
Yet xylazine remains plentiful and easy to obtain. The only requirement is a prescription, and the drug is “readily available” at websites that don’t verify veterinary need for the product, the Drug Enforcement Administration said in an October 2022 report.
“We’re seeing devastating impacts of that in our community right now, because it is not illegal,” says Senator Catherine Cortez Masto, a Democrat from Nevada.
Drug dealers are likely purchasing cheap xylazine and mixing it with opioids to maximize profits, according to the DEA. While US wholesale prices for a kilogram of heroin or fentanyl run to the tens of thousands of dollars, according to the United Nations Office on Drugs and Crime, the same amount of xylazine can be purchased from Chinese suppliers for $20 or less.
US regulators are trying to figure out where dealers get it—by importing it, theft, illegal prescriptions or a combination. Supplies may be coming from China, Mexico, India and Russia.
Theft of xylazine has probably “been happening for much longer than anybody realizes,” says Kelley Detweiler, a regulatory compliance expert who advises veterinarians. A recent case at a veterinary hospital, she says, featured quantity sufficient to “sedate an entire racetrack.” Detweiler says the supply appeared to have been stolen by an employee.
Stung by criticism over their role in the opioid crisis, distributors say they maintain safeguards to ensure xylazine is ordered exclusively for veterinary use. AmerisourceBergen Corp., a drug wholesaler, and Covetrus Inc., an animal health company, say they distribute the drug only to licensed veterinarians. AmerisourceBergen says it ships the product to licensed veterinary wholesalers and watches for “any patterns of ordering that could indicate the potential for diversion.”
Nancy Newman, who runs the Bridge Foundation, a nonprofit organization in the Philadelphia area that supports youth in recovery, lost her son in 2019 to an overdose involving fentanyl and xylazine. Numerous measures could help curb the danger, she says, include funding community-based organizations, increasing awareness of xylazine, providing tests that tell users what’s in illicit drugs they’ve purchased and offering safe injection sites.
“I do know that, whatever that would’ve been, isn’t there,” Newman says. “It still isn’t there despite hundreds of thousands of deaths, just like my son still isn’t there.”
Xylazine was created by Bayer AG in 1962 and approved a decade later for animal use only. Dechra Ltd., which holds rights to the branded drug developed by Bayer, didn’t respond to multiple requests for comment. Bimeda Animal Health, Akorn Operating and Chanelle Pharmaceuticals Manufacturing—all listed on the FDA’s website as approved to make generic xylazine—also didn’t respond.
Other companies have distanced themselves from the drug. Through acquisitions, both a US subsidiary of Boehringer Ingelheim GmbH and Cronus Pharma Specialities India Pvt Ltd. obtained rights to sell xylazine in the US, but neither has manufactured or sold it. Boehringer, based in Germany, recently withdrew its approved application because xylazine “wasn’t a commercial priority,” a spokesperson says. Cronus says it may make the product for animal use in the future.
Xylazine and fentanyl have made it harder for doctors to be sure what they’re dealing with. “If you were treating opioid withdrawal, and someone came in and they said they were using heroin, you could actually assume that they were, in fact, using heroin,” says Ryan Alexander, a medical director at the McNabb Center, a community mental health facility in Knoxville, Tennessee. When the sedative is involved, as frequently occurs now, “we’re not really treating the whole picture.”
There are no approved treatments for xylazine’s effects, according to the FDA; doctors must resort to supportive care when patients’ blood pressure and breathing rate falter. A further potential concern is that the drug may blunt the effectiveness of treatments for opioid withdrawal, potentially leading to worse symptoms and more overdoses.
Officials are trying to make xylazine harder to get. The FDA has moved to better monitor overseas shipments, and it issued an import alert in late February to prevent shipments for nonveterinary purposes. The agency will screen shipments to ensure xylazine products are properly labeled and “en route to legitimate supply chains for veterinary use,” according to a spokesperson. Shipments that appear to be illegal can be detained.
Cortez Masto, the Nevada senator, supports proposed bipartisan legislation that would classify xylazine as a Schedule III controlled substance, putting it alongside oft-abused drugs such as ketamine. It would require all manufacturers and distributors to register with the DEA and document transactions and inventories, and it would allow the agency to prosecute for illegal possession or distribution.
Pennsylvania, Ohio and West Virginia have already moved to classify xylazine as a Schedule III drug. Florida took the more drastic step of making it a Schedule I drug—the most tightly regulated class—in 2018.
But the benefits of erecting such legal barriers may be limited, according to Alixe Dittmore of the National Harm Reduction Coalition, a group that works to control drug use while minimizing punishment of users. Efforts should be focused on understanding xylazine’s effects and how to treat them, she says.
“If scheduling things worked, we wouldn’t have this fentanyl epidemic, which has now turned into a fentanyl and xylazine-type syndemic,” Dittmore says.
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