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[臨床藥學] 2015年新版藥品懷孕分級大圖解~

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美國食品藥物管理局 (FDA) 12/3 宣布PLLR (Pregnancy and Lactation Labeling Rule) 最終版~

宣布自2015年6月30日後 (也就是7月起) 啟用新的藥品仿單標示,沿用幾十年的藥品懷孕分級 (A B C D X) 將走入歷史~

取而代之的是文字資訊,包括懷孕暴露註冊試驗 (pregnancy exposure registry) 資料、懷孕風險摘要與臨床考量等↓↓↓



美國婦產科醫學會 (ACOG) 立刻發布聲明大贊FDA早該廢了這套系統,因為A B C D X系統除了X級不會有人用之外,其他的分類實在是雞肋~(嗯)

準備好習慣新系統了嗎?還是...A B C D X比較好呢?

FDA聲明:http://goo.gl/YhI12J
ACOG聲明:http://goo.gl/cxA4Os

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