Avandia (rosiglitazone)
FDA公告醫療專業人士有關Avandia 之藥物安全議題。依據進行之藥物安全分析資訊顯示:相較於其他治療糖尿病藥物，使用Avandia 治療第二型糖尿病呈現不同程度之缺血性，包括心臟病發作或少數致死案例之心臟相關不良反應。目前回顧性臨床研究依其人口數、療程、及追蹤時間而不同。依據上述資訊，因AVANDIA 引起缺血性心臟病之風險仍不清楚。處方開立者應持續謹慎地對糖尿病病患採取個別之治療方針。
FDA informed healthcare professionals of a potential safety issue related to Avandia (rosiglitazone). An on-going analysis of safety data for the treatment of type 2 diabetes mellitus using Avandia showed differing rates of ischemic cardiovascular events including heart attack or heart-related adverse events, some fatal, relative to other drugs used to treat diabetes mellitus. The clinical studies reviewed to date vary with respect to their populations, treatment regimens, and length of follow-up. Based on these data, the risk of ischemic cardiovascular events due to Avandia remain unclear. Prescribers should continue to carefully make individualized treatment decisions for patients with diabetes mellitus.
(Posted 05/21/2007)
Exjade (deferasirox) Tablets For Oral Suspension
Norvartis與FDA通告醫療專業人員有關Exjade 產品說明單張中警語及不良反應之修改。
Exjade 適應症為：>2歲以上兒童及成人病患，因輸血而導致「慢性鐵質沈著症」。Exjade 上市後偶有急性腎衰竭、致命性之通報事件。致命性不良反應通常發生於多重併發症和重度血液病之病患。除此之外，有血球減少症之不良反應包括：顆粒性白血球缺乏症、嗜中性白血球減少症、血小板減少症等。這些不良反應與Exjade 藥品之關聯性尚未確立。大部份之病患皆已有血液、造血功能不全之疾病。除此之外，亦有蕁麻疹、過敏反應【包括嚴重過敏（anaphylaxis）、血管水腫（angioedema）】、leukocytoclastic vasculitis不良反應之通報。
呼籲醫療人員應對於潛在併發危險因素，年長合併腎功能不全等病患，應監測肌氨酸酐(serum creatinine)濃度及血球計數。若發生不明原因之血球低下時，應停藥。
Novartis and FDA notified healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the product labeling for Exjade, a drug used to treat chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. Cases of acute renal failure, some with a fatal outcome, have been reported following the post marketing use of Exjade. Most of the fatalities occurred in patients with multiple co-morbidities and who were in advanced stages of their hematological disorders. Additionally, there were post marketing reports of cytopenias, including agranulocytosis, neutropenia and thrombocytopenia in patients treated with Exjade where some of the patients died. The relationship of these episodes to treatment with Exjade is uncertain. Most of these patients had preexisting hematologic disorders that are frequently associated with bone marrow failure. Further, cases of leukocytoclastic vasculitis, urticaria, and hypersensitivity reactions (including anaphylaxis and angioedema) were reported.
Healthcare professionals should monitor serum creatinine in patients who are at increased risk of complications, having preexisting renal conditions, are elderly, have co-morbid conditions, or are receiving medicinal products that depress renal function. Blood counts should also be monitored regularly and treatment should be interrupted in patients who develop unexplained cytopenia.(Posted 05/22/2007)
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