藥物警訊（藥師週刊 第1681期）

WinRho SDF (Rho(D) Immune Globulin Intravenous (Human)): Risk of Intravascular Hemolysis
Audience: Hematological healthcare professionals
Cangene, Baxter and FDA notified healthcare professionals that cases of intravascular hemolysis (IVH) and its complications, including fatalities, have been reported in patients treated for immune thrombocytopenic purpura (ITP) with WinRho SDF. IVH can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome. Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation have also been reported. Fatal outcomes associated with IVH and its complications have occurred most frequently in patients of advanced age (age over 65) with co-morbid conditions.
The Boxed Warning informs healthcare professionals that:
* Patients should be closely monitored in a health care setting for at least eight hours after administration
* A dipstick urinalysis should be performed at baseline, 2 hours, 4 hours after administration and prior to the end of the monitoring period
* Patients should be alerted to and monitor for signs and symptoms of IVH, including back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these signs and/or symptoms of IVH within eight hours do not indicate IVH cannot occur subsequently.
* If signs and/or symptoms of IVH are present or if IVH is suspected after WinRho administration, post-treatment laboratory tests should be performed including plasma hemoglobin, urinalysis, haptoglobin, LDH and plasma bilirubin (direct and indirect).
Read the complete MedWatch 2010 Safety summary, including a link to the Dear Healthcare Professional letter, revised Prescribing Information and Information for Patients document, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm203739.htm
Cangene, Baxter公司和FDA發佈藥物安全警訊，通知醫護人員關於患有免疫性血小板減少紫斑症(immune thrombocytopenic purpura, ITP)的病人使用WinRho SDF治療後有發生血管內溶血症(intravascular hemolysis, IVH) 及其併發症而致死的案例。血管內溶血症會導致貧血及多重器官衰竭，包括急性呼吸窘迫症候群。嚴重的併發症，包含嚴重貧血、急性腎功能不全、腎衰竭及散發性血管內血液凝集(DIC)等都曾陸續被通報過。與血管內溶血症及其併發症相關的致死案例，大多發生在同時有其他疾病之65歲以上的病人。
提醒醫護人員注意下列加框警語：
* 至少在給藥後的8小時內，要密切監測病人的身體狀況。
* 需在給藥後、給藥後2小時、4小時及監測完畢前做尿液的分析檢驗。
* 提醒病人注意並監測血管內溶血症的徵兆及症狀，包含背痛、打寒顫、發燒及尿液變色或血尿。若在給藥後8小時內沒有發生這些徵兆或症狀，不代表血管內溶血症之後不會發生。
* 在給藥後，若有發生血管內溶血症的徵兆或症狀或是懷疑發生血管內溶血症，應進一步地檢測生化值和治療，包括Hb, urinalysis, haptoglobin, LDH, plasma bilirubin(direct and indirect)。
相關訊息請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm203739.htm
[Posted 03/10/2010]

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