The FDA said there have been increasing reports of serious side effects from individuals exposed to fentanyl, heroin and other illicit drugs contaminated with xylazine. However, it’s difficult to determine what role the drug itself plays in deaths.
The Food and Drug Administration on Tuesday said it would restrict imports of xylazine, an animal tranquilizer that has “increasingly been found” in illicit drugs like fentanyl and heroin.
The agency said it is coordinating with animal health stakeholders to ensure that drugs containing xylazine are available to veterinarians. “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,” Commissioner Robert Califf said in a statement.
As part of its entry review, FDA said agency staff will consider specific evidence offered by importers that the incoming product is properly labeled, not adulterated and intended for legitimate veterinary use.
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