The U.S. Food and Drug Administration is providing field personnel with guidelines meant to curtail the illegal import of xylazine, a non-opioid approved for use as a veterinary tranquilizer but linked to an increasing number of overdose deaths nationwide.
Studies demonstrate that people often knowingly or unknowingly use xylazine combined with other drugs, especially illicit fentanyl.
“The FDA remains concerned about the increasing prevalence of xylazine mixed with illicit drugs, and this action is one part of broader efforts the agency is undertaking to address the issue,” said FDA Commissioner Robert M. Califf, M.D.
The full scope of xylazine-related overdose deaths is unknown, but reports show that the Northeast United States is the most severely impacted. For example, from 2015 to 2020, the percentage of xylazine-linked overdose deaths increased from 2% to 26% in Pennsylvania. In addition, the non-opioid was involved in 10% of drug overdose deaths in Connecticut in 2020 and 19% in Maryland in 2021.
Also known as “tranq,” xylazine is often added to illicit opioids to lengthen the euphoria. The drug is a central nervous system depressant that can cause dangerously low heart rate, respiratory rate and blood pressure. Repeated use can lead to skin ulcers, abscesses and related complications, likely mediated by the drug’s direct vasoconstricting effect on local blood vessels and decreased skin perfusion.
The FDA seeks to prevent unlawful xylazine imports and ensure that drugs containing xylazine are available to veterinarians for legitimate use.
“We recognize the public health effects of xylazine tainting these illicit drugs and are continuing to ensure that legitimate product is restricted to veterinary use only,” said Tracey Forfa, J.D., director of the FDA’s Center for Veterinary Medicine.