美國白宮：芬太尼–賽拉嗪（Xylazine）組合是一個新的威脅

資料來源：艾麗西亞·奧爾特 / 2023年4月 12 日/ Medscape

白宮週三表示，芬太尼和動物鎮靜劑賽拉嗪的蔓延對美國構成「新興威脅」，這使得美國能夠迅速制定應對計畫，以減少非法藥物的供應、改進檢測並提供更多治療。

在此之前，美國緝毒局警告芬太尼與通常被稱為「鎮靜劑」或「殭屍藥物」的藥物販運和過量服用的情況急劇增加。 藥物過量的迅速增加、嚴重的健康後果（例如無法癒合的深層皮膚傷口）和死亡導致白宮國家藥物管制政策辦公室發出新的警告。

「作為一名醫生，我對芬太尼–賽拉嗪組合的破壞性影響深感不安，作為拜登總統的藥物政策顧問，我非常擔心這種威脅對國家意味著什麼」，毒品政策辦公室主任醫學博士、公共衛生碩士的拉胡爾·古普塔(Rahul Gupta)在一份聲明中說道。

Gupta 援引 美國緝毒局 (DEA) 數據顯示，從 2020 年到 2021 年，美國各地法醫實驗室鑑定出的賽拉嗪數量有所增加，特別是在南部（193%）和西部（112%）。 DEA統計數據還顯示，賽拉嗪陽性過量死亡在南方增加了1,127%，在西部增加了750%，在中西部增加了500%以上，在東北部增加了100%以上。

《2018年支持法案》賦予毒品政策辦公室新的權力來指定新出現的毒品威脅。 一個特別委員會召開會議，確定了在 2019 年和 2020 年期間某種物質已對公眾構成重大威脅的標準。

這是第一次使用這些權力。 古普塔表示，毒品政策工作組將很快開始開會，以制定一項改進賽拉嗪檢測的計畫，因為常規藥物檢測中不會檢測到這種物質； 制定治療和支持性照護方案； 減少非法賽拉嗪供應； 並支持快速研究，例如研究賽拉嗪和芬太尼之間的相互作用。

目前尚不清楚將投入多少資金用於這項工作，但今年 3 月，作為 2024年財政預算的一部分，拜登政府要求提供 461 億美元來支持其毒品管制政策，包括打擊芬太尼。 這比國會批准的 2023 年預算多了 23 億美元。

國會也注意到了這一點。 3月下旬，參議院和眾議院議員組成的兩黨小組提出了《打擊非法賽拉嗪法案》，該法案將使該藥物成為受管制物質。 這將賦予 DEA 更大的追踪和監管權力。

內華達州民主黨參議員凱瑟琳·科爾特斯·馬斯托(Catherine Cortez Masto) 在一份聲明中表示：「這項兩黨立法將確保緝毒局和當地執法部門擁有所需的工具，將賽拉嗪從我們的街道上清除，同時保護其作為獸醫鎮靜劑的重要用途」。

FDA 今年 3 月發布了賽拉嗪進口警報，如果懷疑非法運輸，FDA 有權扣押該藥物的原料或散裝數量。賽拉嗪 (Xylazine) 於 1972 年首次被 FDA 批准作為僅用於動物的鎮靜劑和鎮痛劑。

2022年11 月，FDA 通知醫療保健專業人員，處置藥物過量的納洛酮不太可能可逆轉與賽拉嗪相關的過量用藥，因為動物鎮靜劑不是阿片類藥物。

資料來源：

美國緝毒局：「DEA 報告芬太尼與賽拉嗪混合的廣泛威脅」、「賽拉嗪及其與非法藥物的混合物的威脅日益增長」。

白宮：「拜登–哈里斯政府將芬太尼與賽拉嗪的組合指定為對美國的新興威脅」。

Congress.gov：「H.R.6 – 支持患者和社區法案」。

美國參議員凱瑟琳·科爾特斯·馬斯托 (Catherine Cortez Masto)：「科爾特斯·馬斯托、格拉斯利和哈桑提出立法打擊賽拉嗪Ｊ」。

FDA：「FDA警告人類暴露於甲苯噻嗪的風險」。

此文引自：白宮：芬太尼–賽拉嗪組合是一個新興威脅 – Medscape – 2023 年 4 月 12 日。

White House: Fentanyl-Xylazine Combo an Emerging Threat

Alicia Ault / April 12, 2023 / Medscape

The spread of fentanyl and the animal tranquilizer xylazine is an “emerging threat” to the United States, the White House said Wednesday, which allows it to quickly develop a response plan to reduce supplies of the illicit drugs, improve testing, and provide more treatment.

The action comes on the heels of a U.S. Drug Enforcement Administration warning about a sharp uptick in trafficking and overdoses of fentanyl combined with what is more commonly known as “tranq” or “zombie drug.” The rapid rise in overdoses, severe health consequences such as deep skin wounds that do not heal, and deaths led to the new warning from the White House Office of National Drug Control Policy.

“As a physician, I am deeply troubled about the devastating impact of the fentanyl-xylazine combination, and as President Biden’s drug policy advisor, I am immensely concerned about what this threat means for the nation,” said Rahul Gupta, MD, MPH, director of the drug policy office, in a statement. 

Gupta cited DEA data that shows that from 2020 to 2021, forensic laboratory identifications of xylazine rose across the U.S., especially in the South (193%) and the West (112%). DEA statistics also showed that xylazine-positive overdose deaths increased by 1,127% in the South, 750% in the West, more than 500% in the Midwest, and more than 100% in the Northeast.

The 2018 SUPPORT Act gave the Drug Policy Office new powers to designate emerging drug threats. A special committee that met throughout 2019 and 2020 determined the criteria for when a substance is a significant threat to the public. 

This is the first time these powers have been used. Gupta said a drug policy task force will start meeting soon to come up with a plan that would improve testing for xylazine — as it is not picked up in routine drug tests; come up with treatment and supportive care protocols; reduce the illicit xylazine supply; and support rapid research that might, for instance, study the interactions between xylazine and fentanyl.

It is unclear how much money will be devoted to the effort, but in March, as part of the fiscal 2024 budget, the Biden administration requested $46.1 billion to support its drug control policies, including combating fentanyl. That is $2.3 billion more than Congress approved for 2023.

Congress has also taken notice. A bipartisan group of Senate and House members in late March introduced the Combating Illicit Xylazine Act, which would make the drug a controlled substance. That would give the DEA increased authority to track and regulate it.

“This bipartisan legislation will ensure the DEA and local law enforcement have the tools they need to get xylazine off our streets while protecting its important use as a veterinary tranquilizer,” said Sen. Catherine Cortez Masto (D-Nevada) in a statement.

The FDA in March issued an import alert for xylazine, which gives it the power to detain the raw ingredients or bulk quantities of the drug if the shipments are suspected to be illegal. Xylazine was first approved by the FDA in 1972 as a sedative and analgesic for use only in animals.

In November, the FDA notified health care professionals that the overdose agent naloxone is unlikely to reverse a xylazine-related overdose as the animal tranquilizer is not an opioid. 

Sources: 

U.S. Drug Enforcement Administration: “DEA Reports Widespread Threat of Fentanyl Mixed with Xylazine,” “The Growing Threat of Xylazine and its Mixture with Illicit Drugs.”

The White House: “Biden-⁠Harris Administration Designates Fentanyl Combined with Xylazine as an Emerging Threat to the United States.”

Congress.gov: “H.R.6 – SUPPORT for Patients and Communities Act.”

U.S. Sen. Catherine Cortez Masto: “Cortez Masto, Grassley & Hassan Introduce Legislation to Crack Down On Xylazine.”

FDA: “FDA warns about the risk of xylazine exposure in humans.”

Cite this: White House: Fentanyl-Xylazine Combo an Emerging Threat – Medscape – Apr 12, 2023.