FDA takes action to restrict unlawful import of xylazine
by Lance Roasa, DVM, MS, JD | Mar 20, 2023 | opioid prescribing CE | 0 comments
- Why is the FDA restricting the import of xylazine?
- Is xylazine found in illicit opioids?
- What are xylazine's dangers to humans?
- Is xylazine still available for legitimate veterinary use?
The U.S. Food and Drug Administration has taken action to restrict the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into the country to address a growing public health concern.
The chemical xylazine has increasingly been found in illicit drugs such as unlawfully manufactured fentanyl and other drugs and detected in more and more overdose deaths. Xylazine actually now has it's own street name, "tranq".
The FDA action aims to prevent the drug from entering the U.S. market for illicit purposes while maintaining availability for its legitimate uses in animals.
Veterinarians legitimately use drug products containing xylazine to sedate large animals such as horses and deer, but it is not safe for use in people and may cause serious and life-threatening side effects. It has been identified as a contaminant found in combination with opioids such as illegally manufactured fentanyl and in combination with other criminal products that contain stimulants such as methamphetamine and cocaine. People who use illegal drugs may not be aware of the presence of xylazine.
Related from the VIN News Service and Veterinary Partner:
- Xylazine increasingly involved in opioid overdose deaths
- Horse Tranquilizer Use in Humans Can Be Deadly
While xylazine is not an opioid, it is dangerous because it can depress breathing, blood pressure, heart rate, and body temperature to critical levels. Additionally, people who inject drugs containing xylazine can develop severe skin wounds and patches of dead and rotting tissue that easily become infected and, if left untreated, may lead to amputation. These wounds can develop in areas of the body away from the injection site and may become life-threatening. The agency previously communicated to healthcare providers about the risks to patients exposed to xylazine in illicit drugs.
“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,” said FDA Commissioner Robert M. Califf, M.D. “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.” READ THE FDA ANNOUNCEMENT
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