快樂小藥師 Im pharmacist nichts glücklich

美國食品暨藥物管理局（FDA）今天宣布，將把500多種可能有安全疑慮的感冒、咳嗽和過敏處方藥下架。

FDA要求藥廠在90 天內停止製造這些藥，並在180天內停止出貨，另有部分業者須立即停止製造和出貨。

FDA無法確定這些處方藥是否安全，主要是因為這些藥物不受到後來制定法規的限制。

FDA「藥物評估暨研究中心」（Center for DrugEvaluation and Research, CDER）法規管制室（Office of Compliance）主任奧特（Deborah M. Autor）在1場視訊會議中表示：「我們不知道這些藥有哪些成分、藥效是否適當，以及製作過程如何。問題就出在我們不知道問題是什麼。」

例如有些感冒、咳嗽和過敏藥物標註是「長效緩釋劑」（time-release，成分逐步釋出以延長藥效的藥品）。奧特表示，這類藥的製作過程複雜，FDA並未檢查其活性成分是否會在一段時間內持續釋出，「它們可能釋出太慢、太快，或完全未釋出」。

她說，有些藥則以「不合理」方式將同類型產品結合在一起，例如混合兩種或以上的抗組織胺，或不當標示為可供嬰兒和幼童使用。另有許多藥品包含的成分，和不再適用於2歲以下兒童的非處方藥一樣。

美國「國家兒童醫療中心」（Children'sNational Medical Center）的小兒科醫師韓考克（Yolandra Hancock）讚揚FDA此舉。

她說：「FDA的新決定符合現代小兒醫學避免讓2歲以下兒童服用感冒糖漿的作法，因為這些藥對小孩弊多於利。」

她表示：「我完全支持FDA控制兒童使用這些藥品的作法，此舉極為恰當，早該這麼做。」

The drug products on this list were obtained from the Drug Registration and Listing System (DRLS) in December 2010. For more DRLS Information.

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register and list all of their commercially marketed drug products with the FDA (21 U.S.C. § 360 and 21 CFR 207). Many drug firms do not update their drug listing information with FDA as required by law; consequently, the information in DRLS is both over- and under-inclusive. Therefore, the list above of unapproved prescription cough/cold/allergy drug products may include drugs that are no longer being marketed and/or may not include prescription cough/cold/allergy drug products that are currently being marketed if the drug firm has not listed or updated their information with DRLS. Any unapproved prescription oral cough/cold/allergy drugs that are not on this list are not entitled to any grace period and are subject to immediate enforcement action.

 
** Incomplete information was submitted to FDA's Drug Registration and Listing system 

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