藥物警訊（藥師週刊 第1658期）

資料來源：藥師週刊  第1658期（美國FDA之藥物安全警訊）
資料提供：台大醫院藥劑部

Hospira Brand Propofol and Liposyn Products - Recall
Audience: Anesthesiology and intensivist healthcare professionals, hospital risk managers
Hospira, Inc.and FDA notified healthcare professionals of the recall of 85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30%, and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80 because some of the containers may contain particulate matter. The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process. The affected lots were distributed between July 2009 and October 2009, and no other lots are affected by this recall.?Since these particulate contaminants do not dissolve in blood they could potentially act as emboli and impede blood flow.?Particulates may also cause mechanical damage to the body and may escalate damage through the Systemic Inflammatory Response Syndrome.?Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death.
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 2009 Safety summary, including a link to the firm press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189589.htm

Hospira, Inc.公司和FDA通知醫護人員將回收85批的Liposyn II 10%、Liposyn II 20%、Liposyn III 10%、Liposyn III 20%、和Liposyn III 30%，及73批Propofol Injectable Emulsion 1%，批號為79和80開頭的藥品。回收原因為這些藥品的容器內含有顆粒物質。這些顆粒物質已確認來自廠商製程中所使用的不鏽鋼設備。受污染的批號是在2009年7月到2009年10月之間流通到市面上，其他未受污染的批號不受此次回收的影響。這些顆粒污染物不會溶解在血液中，有可能會形成血栓而阻礙血流。污染的顆粒也可能對人體造成機械性的損傷且可能引發全身性發炎反應症候群(Systemic Inflammatory Response Syndrome，SIRS)而造成漸進性的損害。提供組織的血液受到限制可能會導致中風、呼吸衰竭、腎衰竭、肝衰竭、心臟病發作和(或)死亡。
有關使用此藥品而發生的任何不良反應事件可以電話、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不良反應通報表回郵寄回。

相關訊息請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189589.htm