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藥物警訊(藥師週刊 第1701期)

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   資料來源:藥師週刊 第1701期
 
   

 

 

 

Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient
Audience: Consumers
FDA lab analysis of this herb supplement was found to contain the undeclared drug, desmethyl sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. 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.
Background: This product is marketed as a Natural Herb for Weight Loss, is packaged in plastic bottles containing 30 capsules per bottle and bears UPC 8 97966 00200 7. The affected lot/code being recalled is 101408. The product was sold to distributors and retail stores nationwide and via internet sales. The company has discontinued distribution of Joyful Slim.
Recommendations: Consumers should not consume the product and should return it immediately to the place of purchase for a full refund. Any adverse reactions experienced with the use of this product may be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page], by mail [to address on the pre-addressed form] or by fax [1-800-FDA-0178].
Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA實驗室化驗分析Joyful Slim草本營養補充品發現有未標明的成分N-desmethyl sibutramine,該成分FDA核准用於抑制食慾以減重,現已知sibutramine會使部分病人血壓脈搏大幅增加,可能對有冠狀動脈疾病、鬱血性心衰竭、心律不整或中風病史的患者有顯著的危險。
Joyful Slim草本營養補充品以純天然草本減肥品上市,塑膠瓶裝,每瓶30顆,印有UPC 8 97966 00200 7字樣,回收批號為101408,此產品已透過網路銷售至全球的批發商和零售商店,廠商已不再供貨。建議消費者不應購買此產品,並應立即退還給商家退費。
相關訊息與連結請參考FDA網址:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219983.htm
[Posted 07/22/2008]

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