藥物警訊（藥師週刊 第1662期）

Alli 60 mg capsules (120 count refill kit) : Counterfeit Product
Audience: Consumers, Pharmacy healthcare professionals
FDA notified consumers and healthcare professionals about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). The counterfeit version contained the controlled substance sibutramine and did not contain orlistat, the active ingredient. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Sibutramine can also interact in a harmful way with other medications the consumer may be taking. GSK has determined that the counterfeit product has been sold over the internet. However, there is no evidence at this time that the counterfeit Alli product has been sold through other channels, such as retail stores. The differences between the counterfeit and authentic products are described in both text and photos in the FDA news release.
Consumers who believe they have received counterfeit Alli are asked to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).
Any adverse events that may be related to use should 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 fax [1-800-FDA-0178].
Read the complete MedWatch 2010 Safety summary, including a link to the FDA news release with photographs and description of differences between the authentic and counterfeit product, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA updated January 18 alert with information on laboratory analysis of sibutramine levels in counterfeit product.
Additional FDA laboratory tests on the counterfeit product show that people may be taking 3-times the usual daily dose (or twice the recommended maximum dose) of sibutramine if they are following the dosing directions for Alli. Healthy people who take this much sibutramine can experience anxiety, nausea, heart palpitations, tachycardia (a racing heart), insomnia, and small increases in blood pressure. This excessive amount of sibutramine is dangerous to people who have a history of cardiovascular disease, and can lead to elevated blood pressure, stroke, or heart attack.
Read the MedWatch 2010 Safety summary including a link to both the original January 18 alert and the Update, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197862.htm

FDA發佈藥物安全警訊，提醒消費者和醫護人員有關減肥藥物Alli 60 mg膠囊(120顆裝)，市面上出現可能對人體有害的偽藥。偽藥中以sibutramine取代活性成分orlistat。Sibutramine不可用於某些病人且需要醫生指示才可使用。Sibutramine也可能會與消費者服用的其他藥物產生不良交互作用。葛蘭素史克公司(GSK)指出偽藥已經由網路販售，但目前還沒有發現偽製的Alli產品經由其他管道銷售，例如社區藥局。FDA已在最新消息中以文字敘述和圖片公告偽藥與正品之間的差異。
認為服用到偽造Alli膠囊的消費者請打電話至FDA的刑事調查辦公室(Office of Criminal Investigation)或是登錄到網站(http://www.fda.gov/OCI)。
任何與使用這些藥品相關的不良反應事件可用電話、傳真或線上通報(網址為www.fda.gov/MedWatch/report.htm)至FDA's MedWatch Safety Information和Adverse Event Reporting Program，也可下載FDA不良反應通報表寄回。
相關訊息請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197862.htm
FDA更新1月18號的警訊內容，有關Alli偽藥中sibutramine含量的實驗分析資訊。
FDA針對偽藥的實驗分析顯示，當病人依照Alli膠囊的建議劑量服用該產品時，可能會服用3倍正常劑量的sibutramine (或兩倍的最大建議劑量)。健康的人若服用過多的sibutramine會有焦慮、噁心、心悸、心跳過速、失眠及血壓微升等副作用。對於有心血管疾病史的病人，服用過量的sibutramine是非常危險的，可能會導致血壓上升、中風或引起心臟病發作。
[Posted 01/18/2010]
相關訊息請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197862.htm