Kelley Detweiler is a DEA and regulatory compliance expert who provides controlled-substances risk-management consulting solutions to veterinarians and the health care industry via her partnership with Dr. Peter Weinstein in Simple Solutions For Vets. She is the co-author of “Safeguarding Controlled Substances,” published by AAHA Press. She may be emailed at email@example.comRead Articles Written by Kelley Detweiler
The U.S. Drug Enforcement Administration has issued a public safety alert warning of “a sharp increase” in the trafficking of fentanyl mixed with the equine sedative xylazine.
“Xylazine is making the deadliest drug threat our country has ever faced, fentanyl, even deadlier,” agency administrator Ann Milgram said in a statement released March 20. “DEA has seized xylazine and fentanyl mixtures in 48 of 50 states. The DEA Laboratory System is reporting that, in 2022, approximately 23% of fentanyl powder and 7% of fentanyl pills seized by the DEA contained xylazine.”
Highlighting the human toll, the U.S. Centers for Disease Prevention and Control found that during the 12 months ending in August 2022, more than 70,000 Americans died from drug poisonings involving synthetic opioids such as fentanyl.
The Role of Xylazine
Xylazine is a non-scheduled drug used in equine medicine, cattle and other animals to produce sedation. Veterinarians also use it as an analgesic and preanesthetic.
In veterinary medicine, xylazine is known by the brand names Rompun, Sedazine and AnaSed. On the street, it goes by “tranq,” “tranq dope,” “sleep cut” and “zombie drug.”
The drug has no approved antidote for human use and is resistant to typical reversal agents such as naloxone, significantly raising the odds of an overdose death.
What makes a horse sedative attractive as a cutting agent for illicit opioids? As a long-acting sedative, xylazine can lengthen an opioid’s euphoric effects. As an unscheduled substance, the drug is easier to obtain than other adulterants and is less likely to lead to law enforcement scrutiny.
The public health risk is high, as xylazine-induced blackouts can leave fentanyl users unconscious for hours, with dangerously low blood pressure and heart rates. In addition, xylazine can cause severe wounds, known as eschars, that affect the skin, muscles and nerves. Unlike scabs, eschars are flush within the skin surface, highly persistent and easily infected. Eschar patches can form anywhere on the body and, when left untreated, can lead to necrosis, amputation and other life-threatening conditions.
Getting to the Source
According to the DEA, most fentanyl trafficked in U.S. communities comes from Mexican drug cartels that use chemicals primarily sourced from China. Where the xylazine comes from is up for debate. Some blame diversion from the veterinary supply chain, while others point to illicit underground manufacturing. The reality is likely both.
The sedative has been diverted from veterinary practices and supply chains for years. For example, a 2010 break-in at a Michigan veterinary clinic led state police to stolen vials of ketamine mixed with xylazine. In 2020, three horse sedatives — ketamine, Dormosedan and Rompun — were stolen during a clinic break-in in Alberta, Canada.
In an article published by MedPage Today, Dr. Joseph D’Orazio of Temple University Hospital in Philadelphia said, “What is clear is that the xylazine on the streets is not illicit. It’s pharmaceutical-grade, and it’s being diverted. … They’re finding empty bottles of pharmaceutical-grade xylazine … where dealers are bagging [drugs].”
Philadelphia is among the hardest-hit U.S. cities. According to the Philadelphia Department of Public Health, xylazine is the most common adulterant in the city’s illicit drug supply chain. In addition, the DEA and U.S. Department of Justice reported finding the drug in more than 90% of the heroin and fentanyl samples collected in Philadelphia in 2021.
The Regulatory Environment
This past February, the U.S. Food and Drug Administration moved to restrict the unlawful import of xylazine pharmaceutical ingredients. The FDA also will review xylazine shipments to ensure they go to state-licensed pharmacies, agency-approved manufacturing facilities and veterinarians.
Meanwhile, some states are enacting controls. In New York, for example, xylazine was labeled a Schedule III controlled substance depressant in 2017. In addition, a bill introduced in Illinois this year would make the drug a Schedule I controlled substance.
Nationwide, xylazine is subject to state regulations and the federal Food, Drug and Cosmetic Act. However, because xylazine is not scheduled under the Controlled Substance Act, the DEA is not authorized to control it.
Further federal action is possible. One example involves ecstasy, or MDMA, which became a federally scheduled controlled substance in 1985. Doing the same with xylazine would raise questions such as these:
- If xylazine were a scheduled drug, would veterinary access decrease, impeding patient care?
- Would veterinarians seek non-scheduled, less effective options if xylazine were scheduled?
- How much more paperwork would be required to obtain and safeguard xylazine?
- Would outside parties try harder to divert xylazine?
Conversely, as a DEA-controlled substance, the legitimate supply of xylazine would be subject to annual quota limitations and oversight, including the requirement that suppliers implement a Suspicious Order Monitoring System.
The illicit use has become an unavoidable, escalating national threat. With the regulatory outlook uncertain, one thing is clear: Xylazine has made the opioid epidemic worse.