藥物警訊（藥師週刊 第1699期）

Slim-30 Herb Supplement: Undeclared Drug Ingredient
AUDIENCE: Consumers
FDA lab analysis of Slim-30 Herb Supplement distributed by the company was found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved this product, therefore the safety and effectiveness of the product is unknown. This product poses 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.
BACKGROUND: Slim-30 Herb Supplement is marketed as a Natural Herb for Weight Loss. Slim-30 Herb Supplement is packaged in plastic bottles containing 30 capsules per bottle and bears UPC 8 31457 005009 2. The affected lot/code being recalled is 032009. The product was sold to distributors and retail stores nationwide and China and via internet sales. No illnesses or injuries have been reported to the company to date in connection with this product.
RECOMMENDATION: Consumers should not consume the Slim-30 Herb Supplement and should return it immediately to the place of purchase for a full refund. Report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Online: www.fda.gov/MedWatch/report.htm
Phone: 1-800-332-1088
Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
Fax: 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the company Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219463.htm
FDA經化驗分析Slim-30草本營養補充品發現有未標明的成分N-desmethyl sibutramine及微量的sibutramine，sibutramine是FDA核准用於抑制食慾以減重的成分，但FDA並未核准此產品，因此其安全性及有效性未知而可能危害消費者，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。
Slim-30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 31457 005009 2字樣，回收批號為032009，此產品已透過網路銷售至全美及中國的批發商和零售商店，至今仍未有相關的不良反應事件報告。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/ucm219463.htm
[Posted 07/19/2010]

Vialipro Dietary Supplement: Recall- Undeclared Drug Ingredient
AUDIENCE: Consumers
Good Health, Inc. is conducting a voluntary recall after an FDA lab analyses found that the product tested from certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making this product an unapproved drug. The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs.
BACKGROUND: This product is currently being sold as a dietary supplement throughout the U.S. The affected lot numbers being recalled can be found in the company's Press Release.
RECOMMENDATION: Consumers who have purchased Vialipro should discontinue its use and return it to Good Health, Inc.
Report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Online: www.fda.gov/MedWatch/report.htm
Phone: 1-800-332-1088
Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
Fax: 1-800-FDA-0178
Read the complete MedWatch 2010 safety summary, including a link to the company Press Release , at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219580.htm
FDA化驗分析Vialipro發現含有sildenafil的類似物sulfoaildenafil，sildenafil經FDA核准用於男性勃起功能障礙，但Vialipro成分標示不明可能與其他處方藥物如nitroglycerin產生交互作用，造成血壓下降至危險的程度而危害消費者，且糖尿病患、高血壓、高血脂或心臟疾患的消費者常使用其他的處方藥物，故Good Health公司自願性回收。
此產品現以營養補充品在全美銷售，回收的批號為：80409、80661、81146、90132、90265、90587、90826、91065、00197、'00347，建議購買Vialipro的消費者應立即停用並將產品退回Good Health公司。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219580.htm
[Posted 07/20/2010]
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