FDA Restricts Unlawful Import of Xylazine

The FDA has placed xylazine on an import alert for detention without physical examination of the active pharmaceutical ingredient and unapproved finished drug products.

Xylazine is approved for use in sedating large animals such as horses and deer, but it has been found in combination with opioids including illicit fentanyl and in illicit products containing stimulants such as methamphetamine and cocaine.

“Xylazine is not approved for use in humans,” the agency said, adding that the drug can lead to serious and life-threatening side effects, including depressed breathing, blood pressure, heart rate and body temperature at critical levels.

The approved drug will remain available for approved uses in animals, the agency said.