FDA Takes Action Against Animal Tranquilizer Tied to Fatal ODs
The U.S. Food and Drug Administration said Tuesday that it has taken action to restrict imports of the veterinary tranquilizer xylazine to prevent illicit use of the drug.
While veterinarians use products containing xylazine to sedate large animals such as horses and deer, the drug is not safe for people. It is sold on the street under the names tranq, Philly dope and zombie drug.
Federal officials say illicit drugs, including fentanyl and meth and cocaine, are often laced with xylazine. The drug has been detected in a growing number of overdose deaths. People who use illicit drugs may not be aware they contain xylazine, the FDA warned.
"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 this issue," FDA Commissioner Dr. Robert Califf said in an agency news release. "We will continue to use all tools at our disposal and partner with the Drug Enforcement Administration and other federal, state, local agencies and stakeholders as appropriate to stem these illicit activities and protect public health."
The FDA wants to ensure that imports of drugs containing xylazine are intended for legitimate veterinary use. That includes ingredients for processing at a facility that makes FDA-approved xylazine, compounding at licensed pharmacies and veterinary practices, as well as finished products for veterinary use.
This new alert puts xylazine imports under increased scrutiny. FDA staffers may detain a shipment if it appears to be in violation of the law.
The announcement said FDA staff will consider specific evidence offered by importers that the incoming product is properly labeled, not adulterated and for legitimate veterinary 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," Tracey Forfa, director of the FDA's Center for Veterinary Medicine, said in the release.
Xylazine can depress breathing, blood pressure, heart rate and body temperature to critical levels in humans.
The FDA said people who inject drugs containing xylazine can develop severe skin wounds and patches of dead and rotting tissue. These can become infected and may lead to amputation. Life-threatening wounds can also develop in areas of the body away from the injection site.
The FDA and its Office of Criminal Investigations are working with other officials to investigate potential criminal activity involving xylazine, both online and in person.
The U.S. National Institutes of Health has more on xylazine.
SOURCE: U.S. Food and Drug Administration, news release, Feb. 28, 2023