Quantity of phenibut in dietary supplements before and after FDA warnings
Quantity of phenibut in dietary supplements before and after FDA warnings
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DOI：
10.1080/15563650.2021.1973020
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发表时间：
2021-09-20
影响因子：
3.3
通讯作者：
Gerona, Roy
中科院分区：
文献类型：
--
作者：
Cohen, Pieter A.;Ellison, Ross R.;Gerona, Roy
在俄罗斯，Phenibut被用于治疗焦虑、失眠、酒精戒断和其他疾病。然而，这种药物有滥用的可能性，可能导致嗜睡、谵妄、精神病和昏迷。在美国（US），美国食品和药物管理局（FDA）从未批准使用phenibut作为处方药，但该药物可在非处方膳食补充剂中使用。超过80例昏迷和死亡病例与服用和停药有关，FDA最近警告说，这种药物不允许用于非处方补充剂。我们设计了我们的研究，以确定在FDA警告之前和之后非处方补充剂中phenibut的存在和数量。方法：如果产品（a）在标签上列出了phenibut或其同义词作为成分，（B）被标记为膳食补充剂，（c）在FDA警告之前和之后都可用于销售，则包括Phenibut产品。通过液相色谱-飞行时间质谱法分析补充剂;通过同位素稀释法进行定量。结果4个品牌的膳食补充剂标示含有苯丁砜，符合纳入标准。在FDA警告之前，四个品牌中有两个含有phenibut，每份剂量为484 mg和487 mg。在FDA发出警告后，所有四种产品都含有phenibut，剂量从每份21毫克到1,164毫克不等。仅在FDA警告后，两个品牌才首次检测到苯丁酸，并且在FDA警告后，四种产品中的三种产品的苯丁酸含量增加。每剂量检测到的药物比俄罗斯生产的典型250 mg片剂高出450%。结论在FDA发布不允许在膳食补充剂中使用苯异丁酸的建议后，4种非处方苯异丁酸补充剂中有3种的苯异丁酸含量增加。
Introduction Phenibut is used to treat anxiety, insomnia, alcohol withdrawal and other conditions in Russia. The drug, however, has abuse potential and may cause lethargy, delirium, psychosis and coma. In the United States (US), the US Food and Drug Administration (FDA) has never approved the use of phenibut as a prescription medication, but the drug is available over-the-counter in dietary supplements. More than 80 cases of coma and death have been associated with phenibut consumption and withdrawal, and the FDA recently warned that the drug is not permitted in over-the-counter supplements. We designed our study to determine the presence and quantity of phenibut in over-the-counter supplements before and after the FDA warnings. Methods Phenibut products were included if they (a) listed phenibut or a synonym as an ingredient on the label, (b) were labeled as a dietary supplement, and (c) were available for sale both before and after the FDA warning. Supplements were analyzed by liquid chromatography time-of-flight mass spectrometry; quantification was performed by isotope dilution method. Results Four brands of dietary supplements labeled as containing phenibut met the inclusion criteria. Prior to the FDA warnings, two of the four brands contained phenibut, at dosages of 484 mg and 487 mg per serving. After the FDA warning, all four products contained phenibut, ranging in dosages from 21 mg to 1,164 mg per serving. Phenibut was first detected only after the FDA warnings in two brands, and the quantity of phenibut increased in three of four products after the FDA warnings. Quantities detected per dose were as much as 450% greater than a typical 250 mg pharmaceutical tablet manufactured in Russia. Conclusion Following FDA issuing an advisory that phenibut is not permitted in dietary supplements, the quantity of phenibut increased in 3 of 4 brands of over-the-counter phenibut supplements.