FDA takes action to curb illegal importation of xylazine, an animal tranquilizer linked to overdose deaths

The U.S. Food and Drug Administration announced on Tuesday that it is taking action to curb the smuggling of the veterinary drug xylazine, which is “increasingly found” in illegal drug shipments in the country.

The action, an import warning, makes it possible to delay shipments of xylazine and the ingredients used to make it. The warning “aims to prevent the drug from entering the U.S. market for illegal purposes,” the agency said in a statement. An import warning allows the FDA to delay shipments of products that appear to violate FDA laws and regulations.

The drug, an animal tranquilizer used by veterinarians to calm large animals such as horses, will still be available for “legitimate use”.

Xylazine can cause “serious and life-threatening effects” when used in humans, including severe skin wounds and dead tissue, according to the FDA. It can also depress breathing, blood pressure, and heart rate to “critical levels.”

Xylazine has been found in overdose deaths nationwide, including in California and Pennsylvania. Because xylazine is used in combination with other agents, it is difficult to determine what role this drug plays in overdose deaths. The Food and Drug Administration said it was identified as a contaminant “found in combination with opioids,” including the synthetic drug fentanyl. It has also been mixed with stimulants such as methamphetamine and cocaine.

There are concerns that xylazine may not respond to treatment options such as naloxone, which can reverse opioid overdose, and routine toxicology screens may not detect its presence, according to an FDA statement released in late 2022. People who use drugs may also not be aware that they are buying xylazine-contaminated substances, the FDA said at the time.

“The FDA remains concerned about the growing proliferation of xylazine mixed with illegal drugs, and this action is part of a broader effort by the agency to address this issue,” FDA Commissioner Robert M. Califf said in a press release announcing the danger of imports. . “We will continue to use every tool at our disposal and work with the Drug Enforcement Administration and other federal, state, local agencies and stakeholders to stop this illegal activity and protect public health.”

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