一般醫療新知 : 食品藥物管理局提醒醫師letrozole成分藥品適應症為治療乳癌，非用於治療婦女不孕症
依據 99年 4月 9日美國媒體報導，美國約 29.3%不孕症婦女被醫師處方以治療乳癌藥品 Femara（主要成分為 letrozole）治療其不孕症。研究者提出，該藥品未依核准之適應症而用來處方治療不孕症，恐增加對胎兒之風險，且目前並未有足夠的證據顯示該藥品對不孕症具有療效。
經查，衛生署核准含 letrozole成分之藥品製劑許可證有 1張，所核准之適應症為「接受抗動情激素治療失敗的自然或人工停經後之末期乳癌病人之治療。停經後之局部晚期或轉移性乳癌婦女患者之第一線治療用藥。荷爾蒙接受器呈陽性及 LN METASTASIS POSITIVE之乳癌病人作為 TAMOXIFEN輔助療法之後的延伸治療。停經後荷爾蒙接受器呈陽性反應的初期乳癌病人之輔助治療。」，另查其仿單標示有「於懷孕和哺乳期間禁止使用本品」 。
食品藥物管理局提醒醫師 letrozole成分藥品適應症為治療乳癌，非用於治療婦女不孕症。任何未依藥品許可證所載之適應症而為藥品之使用（ off-label use），要格外注意利益及風險之評估，且所發生之藥品不良反應無法獲得藥害救濟。
此外，食品藥物管理局已建立藥物安全資訊主動監控機制，除有藥物不良反應通報系統之外，對於安全有關訊息，隨時進行瞭解，以保障民眾之用藥安全，提醒醫療人員或病患懷疑因為使用（服用）藥品導致不良反應發生時，請立即通報給衛生署所建置之全國藥物不良反應通報中心，藥物不良反應通報專線 02-2396-0100，網站： http://adr.doh.gov.tw。
此篇文章為網友個人意見，不代表本站立場.
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