Will Xylazine Become a Controlled Substance?
There's serious discussion at the highest levels of the U.S. government -- among both congressional lawmakers and the Drug Enforcement Administration (DEA) -- about making the veterinary sedative xylazine a controlled substance.
In a statement, the American Veterinary Medical Association said that it is "closely engaged with the relevant congressional offices and committees" that are discussing scheduling xylazine, noting that it understands that the DEA "has begun its internal process to schedule the drug."
Indeed, one source told MedPage Today that the DEA has conducted an 8-Factor Analysis for xylazine, which is an assessment of the drug's abuse potential that is a required step in the scheduling process.
Additionally, the DEA has said that the "two-part process" to schedule a substance has been in the works since October 2021, according to Fox News. The agency told the news outlet that the process involves sending data to HHS and requesting a scheduling recommendation.
The DEA sent HHS "supplemental information" in September 2022 to "accelerate" the scheduling process, and DEA is "still waiting on HHS to provide a scheduling recommendation," the article noted.
The DEA did not return several requests for comment from MedPage Today.
A spokesperson for the FDA, which is the HHS agency tasked with reviewing the 8-Factor Analysis, said it is "continuing to investigate the impact of xylazine presence in the illicit drug supply and will provide an update when new information is available."
"We defer to DEA to confirm what actions they have taken with regard to the scheduling process, but we are in regular contact with them pursuant to the Memorandum of Understanding between our two agencies," the spokesperson added.
A Congressional Research Service report from February 2 titled, "Xylazine: Considerations for Federal Control," noted that "either Congress or DEA (in conjunction with FDA) could decide to schedule xylazine."
"The CSA [Controlled Substances Act]-required process for DEA and FDA to schedule a substance can be time consuming, whereas Congress may pass (and the President may sign) a bill scheduling a substance and is not bound by the CSA's procedural requirements," according to the report.
The report also noted that regulators would have to consider which schedule it would belong to, from the most restrictive Schedule I to the more lenient Schedules III-V.
It is not known which legislator requested the report.
Xylazine has popped up on regulators' radars as it increasingly has been mixed with the opioid fentanyl. The problem has been particularly prevalent in the Northeast -- especially in Philadelphia, where some 90% of fentanyl samples also contain xylazine -- but is reportedly spreading across the U.S.
Since it's a sedative, one of the problems is that it knocks people out, leaving them vulnerable to assault or robbery. Another challenge is that the opioid overdose reversal agent naloxone (Narcan) may appear not to work. It can still reverse the effects of the opioid, but additional steps may be needed to treat the effects of sedative overdose.
Another area of concern has been the wounds that have been more severe than those seen with injection drug use in the past, physicians said. "With xylazine, the wounds are much more severe, much deeper, and much harder to manage," Joseph D'Orazio, MD, of Temple University Hospital in Philadelphia, previously told MedPage Today.
D'Orazio and others believe the xylazine is mostly pharmaceutical-grade and has likely been diverted. Pictures taken in xylazine hotspots in Philadelphia have shown bottles with the label "VET One," which is distributed by MWI Animal Health, a subsidiary of AmerisourceBergen.
Lauren Esposito, a spokesperson for AmerisourceBergen, said, "We continuously evaluate and expand the measures we have implemented to maintain the integrity of every order we ship. We perform due diligence on all customers and ensure they are appropriately licensed by regulatory agencies."
"We also maintain robust processes and systems that track and monitor the products that move through our distribution channels," Esposito added. "If we identify any patterns of ordering that could indicate the potential for diversion, we evaluate and act appropriately."
Esposito added that xylazine "is stocked and distributed exclusively through our animal health distribution centers and shipped only to licensed veterinary providers and other licensed wholesalers."
She declined to share 10-year sales data for xylazine products.
Andrew Kolodny, MD, an expert in opioid policy and addiction medicine at Brandeis University in Massachusetts, said xylazine is probably widely diverted because it's unscheduled.
"If it were scheduled, distributors would have to have a suspicious order monitoring system. It's a DEA [requirement] that would tell you, for example, your Philadelphia region, or a particular veterinary practice you're distributing to, are outliers and you can't continue to fill that order. You have to report them," he explained.
"For sure, you would not see xylazine all over the place if it was scheduled," Kolodny added.
Xylazine, an animal tranquilizer, is latest threat in the opioid epidemic: What you need to know
What is fentanyl and why is it so dangerous?
A new threat has emerged in the United States' illicit drug supply: an animal tranquilizer called xylazine.
The drug is showing up in synthetic opioids, particularly fentanyl, leading to more overdoses and alarming side effects, according to the White House Office of National Drug Control.
While most jurisdictions don't routinely test for xylazine in postmortem toxicology, the Drug Enforcement Administration estimates xylazine was involved in at least 1,281 overdose deaths in the Northeast and 1,423 in the South in 2021.
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Last week, ONDC director Dr. Rahul Gupta hosted a listening session with local public health and safety leaders to discuss trends related to xylazine and efforts to address it, including plans for tracking, substance use treatment, and harm reduction.
Xylazine was created in the 1960s and is used in veterinary medicine to sedate animals during procedures or diagnostic testing, according to the DEA.
Xylazine is not approved by the Food and Drug Administration for human use.
While it has been given in the past for household pets, the sedative is now typically used for larger animals like horse, sheep and elk.
It's most commonly used in cattle as it's one of the few sedatives studied in food animals, said Dr. Bernd Driessen, professor of anesthesiology at the University of Pennsylvania School of Veterinary Medicine.
The drug is available in liquid form and sold in vials or preloaded syringes in veterinary medicine, the DEA said, but it can also be sold online in powder form.
Xylazine side effects include open wounds
Anecdotal reports indicate using xylazine causes open wounds to "spontaneously develop," said Maryann Mason, associate professor of emergency medicine at Northwestern University Feinberg School of Medicine.
These open wounds may lead to necrosis, or dead tissue, and eventually amputation of affected limbs, she said.
Xylazine is not an opioid and doesn't target the same receptors, but the Michigan Poison Center at Wayne State University says it has similar effects, including:
The poison center said xylazine can be swallowed, snorted, injected, smoked or inhaled. The DEA said it's unclear whether it can be vaped.
Is xylazine safe? What should you do if someone overdoses?
There is no amount of xylazine that is safe for humans, said Dr. Neeraj Chhabra, emergency medicine physician and medical toxicologist at Cook County Health in Chicago.
Humans are about 10 to 20 times more sensitive to xylazine than animals are, Driessen said.
The sedative can be lethal because it slows down breathing, Mason said, like an opioid overdose. However, because the animal tranquilizer is not an opioid, an overdose can't be reversed by naloxone, known as Narcan.
"Xylazine is not responsive to naloxone like heroin and fentanyl are," Chhabra said. Medical providers "may have to provide certain support measures in addition to naloxone," like breathing assistance.
An antagonist that reverses the sedative effects of xylazine, called atipamezole, is used in veterinary medicine. While it has been studied in humans, it is not approved for humans by the FDA, said Driessen.
In the event of a suspected overdose, the National Institute of Drug Abuse still recommends giving naloxone because xylazine is frequently combined with opioids. As with all overdoses, the agency also urges calling emergency medical services.
Where is xylazine showing up?
In an October report, the DEA said exposure to xylazine is most common amongst people who use heroin, fentanyl or cocaine.
The administration said xylazine is commonly found in drugs that have two or more substances present. While some users actively seek substances with xylazine, others are surprised by the adulterated supply.
'Zombie' drug? Other names for xylazine
Brand names for xylazine include:
In the illicit drug market, providers have heard xylazine or drugs laced with xylazine referred to as:
The drug was also called "anestesia de caballo," or horse anesthetic in Spanish, in Puerto Rico where it was first noted as an adulterant in the illicit drug supply in the early 2000s, according to the DEA report.
What Is Xylazine? How Is The Drug “Zombifying” People’s Bodies? All You Need To Know
Xylazine, or “tranq” is the new drug wreaking major havoc in cities across the US. Reports say the deadly symptoms include skin rotting and "zombifying" people.
Xylazine or the ‘zombie drug’ has been ratified by the country's Food and Drug Administration (FDA) for veterinary purposes. It was earlier used for cutting heroin, but shockingly its most recent discovery has been discovered in fentanyl and other illicit drugs according to sources.
The Drug OD situation has been an issue for a long time and according to statistics, a person dies of a drug overdose every five minutes in America.
Xylazine, otherwise known as Tranq, is the new drug creating mayhem in major cities across the country with its devastating effects of "skin-eating" and zombifying people addicted to this.
What is Xylazine?
Did You Know?
Over 2% of the world population has an alcohol or illicit drug addiction.
What is Xylazine Used For?
What Is Cordyceps Fungus? Did The Chinese Army Intrude Into Indian Territory To Find It? Find Out About The Usage, Location, And Other Details Here!
How is Xylazine "Zombifying people's bodies"?
The Current Scenario Of The Drug
The current situation of drug abuse foreshadows the future of the overdose crisis, increasingly driven by powerful synthetic compounds mixed into potent combinations.
"Tranq Dope" is a mix of Fentanyl, the opioid that has decimated America's youth, and the veterinary drug Xylazine. It is currently being sold on the streets for just a few dollars per bag. Public health authorities are horrified by its spread and worried about the terrible scars it leaves on individuals who use it. With its catastrophic results, including the ability to visibly damage the user's skin, "tranq dope," has raised concerns in the US.
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