美國FDA警告:網上出售未批藥物風險高

美國FDA警告網絡商家銷售未經批准的減肥藥

(路透社)— 美國食品藥品監督管理局(FDA)於週二表示,已向四家公司發出警告信,因為這些公司銷售未經批准的GLP-1藥物,包括賽美特和替扎瑞德(tirzepatide),這些成分是受歡迎的糖尿病和減肥藥的活性成分。

這些警告信於上週發送給Xcel Peptides、Swisschems、Summit Research和Prime Peptides,這些公司在十月份的網站檢查中被發現違規。

這些網站上標示的產品聲明為「僅供研究使用」或「不適合人類消費或臨床使用」。然而,FDA收集的證據顯示,這些產品實際上是旨在用作人類藥物。

此外,FDA還向Veronvy發出警告信,該公司提供未經批准且標示不當的口服GLP-1產品,其中一款聲稱已獲得FDA批准。

FDA觀察到,該網站提供的錯誤標示產品誤導性地暗示這些藥物產品以某種方式獲得了FDA的批准或認可。

這些公司必須在收到信件後的15個工作日內通知FDA,說明已採取的具體行動來解決任何違規問題。若未能充分解決違規問題,可能會導致法律行動,包括但不限於扣押和禁制令,FDA表示。

賽美特是Novo Nordisk(NYSE:NVO)的Wegovy和Ozempic的活性成分,而Eli Lilly(NYSE:LLY)的糖尿病藥物Mounjaro和減肥藥Zepbound使用的成分是替扎瑞德。

一些網站還提供Eli Lilly的實驗性下一代減肥藥物retatrutide。

在此背景下,FDA的警告信無疑是對市場上不合規產品的一次重要打擊,這不僅保護了消費者的健康,也強調了監管機構在保護公共健康方面的責任。隨著健康和減肥產品需求的增加,這些未經批准的替代品可能會吸引那些尋求快速解決方案的消費者,但其潛在的健康風險卻不容忽視。這一事件也提醒我們,消費者在選擇健康產品時應保持警惕,並確保所選擇的產品是經過監管機構認可的。

以上文章由特價GPT API根據網上資料所翻譯及撰寫,過程中沒有任何人類參與 🙂

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