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FDA takes action to restrict unlawful import of Xylazine

Veterinarians use drug products that contain xylazine to sedate large animals like horses and deer.

ST. PETERSBURG, Fla. — The U.S. Food and Drug Administration is taking action to crack down on a chemical used in animal tranquilizers found in drugs that has led to hospitalizations and even death in the state of Florida.

The restriction comes as the drug product, xylazine, becomes a growing public health concern, the FDA said in a news release. The chemical has been found in illicit drugs such as illicitly manufactured fentanyl and it is not approved for use in humans, the FDA reports. It's also been found increasingly in overdose deaths.

Under the new guidance, the FDA says divisions can take into custody without physical examination shipments containing xylazine that raise concerns.

"This action aims to prevent the drug from entering the U.S. market for illicit purposes, while maintaining availability for its legitimate uses in animals," the FDA said. 

The drug, xylazine, can be found in products veterinarians use to sedate large animals such as horses and deer. However, the FDA says it's not safe for people to use and could cause serious and life-threatening side effects. While it is not an opioid, the FDA has found traces of xylazine in fentanyl, methamphetamine and cocaine and says people who use the illicit drugs could be unaware of its presence.

10 Investigates looked into the deaths associated with xylazine and fentanyl in the Tampa Bay area back in 2022.

After reaching out to medical examiners in 10 counties, our 10 Investigates team found at least 33 people have died from a combination of fentanyl and xylazine in the Tampa Bay area since 2019: 12 people in Polk County, eight in Manatee, seven in Sarasota, three in Highlands, one in Pasco, one in Pinellas, and one in Citrus.

The FDA said xylazine "is dangerous because it can depress breathing, blood pressure, heart rate and body temperature to critical levels." Other side effects include severe skin wounds and patches of dead and rotting tissue that can become infected and could lead to amputation. 

“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 Robert M. Califf, M.D. said in a statement. “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.” 

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