FDA to restrict imports of 'tranq,' animal sedative tied to drug overdoses
The Food and Drug Administration on Tuesday announced it is cracking down on the illegal importation of xylazine, a potent animal tranquilizer that is increasingly being mixed into the nation's illicit drug supply and causing ghastly, rotting wounds on the skin of drug users.
The FDA's import alert allows authorities to stop shipments of the finished drug and its ingredients. Xylazine is legal and commonly used by veterinarians to sedate large animals, but it is now being found in blood samples of overdose victims across the country.
The drug, known as "tranq" on the street, has alarmed public health experts, law enforcement officers and lawmakers already struggling to control an opioid crisis that is killing thousands each month. In recent years, the impact of xylazine has been particularly acute in Philadelphia, where the drug has been discovered in an overwhelming number of street opioid samples and as of 2019, in 31 percent of all victims of unintentional fatal overdoses in which fentanyl or heroin were detected.
People began ingesting the animal tranquilizer in Puerto Rico in the 2000s, according to the Drug Enforcement Administration, which on Tuesday lauded the FDA's move and vowed to stem "the devastating tide of drug poisonings plaguing our nation."
"The mixing of xylazine into other illicit drugs, particularly fentanyl, is devastating communities across the country," DEA head Anne Milgram said in a statement Tuesday.
Doctors have to amputate limbs because of infections from "skin wounds and patches of dead and rotting tissue," according to the FDA. At Voices of Hope Maryland, an addiction recovery group in Cecil County near the Delaware border, wound care nurse Jason Bienert says he tends to between 13 and 30 patients a week dealing with xylazine sores.
"The skin is fully rotted, and the edges are purple. Blistered. People continually inject into these edges and make the wounds larger," said Bienert, who recalled his first patient had to have her hand amputated because of the wounds.
Users don't always know xylazine is mixed into their fentanyl. Sometimes, Bienert said, the powerful sedative knocks them out for so long - and there is so little fentanyl in their drug mix - that they wake up suffering agonizing opioid withdrawal.
The sedative helps extend the high of fentanyl, which is powerful but short-acting, said Jon Zibbell, a senior public health analyst in the behavioral and urban health program at RTI International, a North Carolina think tank.
"In colloquial terms, it gives the drugs legs," Zibbell said.
Another danger is that xylazine, which is not an opioid, may hinder the use of naloxone, the drug commonly used to reverse opioid overdoses, the FDA warns.
The drug has now been found in samples from 32 states, according to Aegis Sciences Corp., a private lab that tests urine and saliva, mostly for doctors in rehab and recovery facilities "It's a fairly wide distribution," said Andrew Holt, a clinical pharmacist with the Tennessee-based company.
On Tuesday, police in Charleston, S.C., warned that xylazine had been found in blue tablets made to look like pain pills. In nearby Clarendon County, police said, there had been eight overdoses from similar pills.
It remains unclear how the FDA's push will affect drug dealers buying and using xylazine to stretch their supplies. An agency spokesperson acknowledged that "the source of xylazine for illicit use is not fully understood."
In the fall, the DEA and the Justice Department issued an intelligence report warning that the drug was being mixed with fentanyl, cocaine, heroin and other drugs, and was for sale online from China for as a little as $6 per kilogram.
"At this low price, its use as an adulterant may increase the profit for illicit drug traffickers, as its psychoactive effects allows them to reduce the amount of fentanyl; or heroin used in a mixture," the report said.
The FDA said the alert was "designed to ensure that imports of drugs containing xylazine into the country are intended for the legitimate veterinary supply." In its release, the FDA said its criminal investigations office is working with local, state and federal agencies to "investigate xylazine-related activities that could be subject to criminal prosecution, including online and in-person conduct."
The American Veterinary Medical Association said it supported the announcement on Tuesday, adding that it would continue "to work with congressional offices and federal agencies to maintain the appropriate access veterinarians have to xylazine, a drug that has critically important uses in veterinary medicine."
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