衛署擬:醫師處方梵蒂雅要評估 患者簽同意書

[MK]

http://tw.news.yahoo.com/article/url/d/ ... 2do66.html
更新日期:2010/09/24 13:35
糖尿病藥物「梵蒂雅」恐提高心臟病風險，美國食品藥物管理局日前嚴格要求限制使用，歐盟甚至要求下架，至於衛生署繼七月中要求限縮使用，未來傾向讓醫師開立梵蒂雅前，必須先寫評估紀錄，並讓患者簽署同意書。(陳奕華報導)


研究指出，梵蒂雅可能提高心血管疾病與中風風險，衛生署七月十五號開會評估後，決定限縮梵蒂雅使用，除了要求醫師把梵蒂雅做為最後一線藥物，同時也限制缺血性心臟病與心衰竭患者不能使用，而在歐盟要求暫停販售，美國宣布加強管控使用後，衛生署也發文給藥廠，要求提出風險管控計畫，並在近期展開討論，不排除讓醫師處方梵蒂雅前，要先寫評估紀錄，同時讓患者簽署同意書。


食品藥物管理局副組長許蒨文說：「評估過程要做書面紀錄，要留有這個紀錄，而且告訴病患可能心血管風險的訊息，讓他可能要簽名，作成書面評估紀錄，才使用這個產品。」


由於國內每四個糖尿病患，就有一人服用梵蒂雅，相關消息一出，可能增加患者疑慮，醫師提醒，患者不要冒然停藥，否則血糖升高，潛在風險反而更高，如果不放心，應該先跟醫師討論，再決定是否停藥或換藥。

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