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藥物警訊(藥師週刊 第1659期)

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資料來源:藥師週刊  第1659期
資料提供:台大醫院藥劑部


Pai You Guo, Marketed as Dietary Supplement - Recall
Audience: Consumers
GMP Herbal Products and FDA notified consumers and healthcare professionals of a recall of Pai You Guo, a weight loss dietary supplement, due to the presence of undeclared drug ingredients.?FDA lab analyses of dietary supplements were found to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss; and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States. The FDA has not approved the Pai You Guo products as a drug; therefore the safety and effectiveness of this product is unknown. The product is sold either in a box of 30 capsules or a bag of 10 g powder. The affected products were sold and distributed nationwide via the internet.
FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Consumers are advised to destroy the affected products or return them to the company’s address in Westminster, CA.
Read the complete MedWatch 2009 Safety summary, including a link to the firm press release at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
GMP Herbal Products公司和FDA通知消費者和醫護人員將回收名為Pai You Guo的減肥產品,因為此產品含有未經申報的成分。FDA實驗室分析這些減肥產品發現內含有未經申報的sibutramine和phenolphthalein。Sibutramine是FDA核准用於抑制食慾的減肥藥物。Phenolphthalein是用於化學實驗且疑似會引發癌症而未核准在美國上市的溶液。FDA並未核准Pai You Guo產品為藥品。因此,此產品的安全性和有效性是未知的。Pai You Guo產品是以30粒盒裝及10克粉末包裝經由網路流通及販賣到全世界。
FDA提醒消費者這些產品會對其健康造成威脅。因為某些病人服用sibutramine後會引起血壓上升及/或心跳加速的副作用。對於有冠狀動脈疾病、充血性心衰竭、心律不整或中風病史的病人使用sibutramine也會有較大的風險存在。建議消費者銷毀這些產品或退回公司。

相關訊息請參考FDA網址:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190531.htm [Posted 11/13/2009]

資料來源:美國FDA之藥物安全警訊
資料提供:台大醫院藥劑部

【藥物警訊補充】
台灣衛生署並表示,國內從未核准上述產品,倘有非法販售情形,即屬於藥事法第22條1項2款所規定之禁藥,依同法第82條規定「製造或輸入偽藥或禁藥者,處十年以下有期徒刑,得併科新臺幣一千萬元以下罰金…因過失犯第一項之罪者,處三年以下有期徒刑、拘役或科新臺幣五十萬元以下罰金。」,另依同法第83條規定「明知為偽藥或禁藥,而販賣、供應、調劑、運送、寄藏、牙保、轉讓或意圖販賣而陳列者,處七年以下有期徒刑,得併科新臺幣五百萬元以下罰金…因過失犯第一項之罪者,處二年以下有期徒刑、拘役或科新臺幣三十萬元以下罰金。」
衛生署已核准用於肥胖或體重過重病人之藥品,均列屬醫師處方藥品,依藥事法第50條規定,醫師處方藥品非經醫師處方,不得調劑供應。衛生署並提醒消費大眾注意,藥品必須對症及適量使用才能夠治病,否則極有可能產生嚴重不良反應。身體倘有不適或有醫療需求,均應先行就醫,經醫師診斷後開給處方,再將處方箋,交藥師調劑,切勿自行購買處方藥品服用,更不要去購買來源不明藥品,以免發生無法預期之副作用或併發症。
衛生署於獲悉此項之消息後,除加強督導地方衛生機關取締違規之藥品外,亦鼓勵民眾們協助監督檢舉非法藥物,並且設置檢舉不法藥物專用電子信箱: drug@doh.gov.tw及免付費服務電話:,以供民眾檢舉、諮詢使用,希望民眾善加利用。
http://www.doh.gov.tw/CHT2006/other/ShowCopy.aspx?doc_no=73873&class_no=25