2009年2月20日 星期五

FDA懷孕用藥等級 Pregnancy Labeling of Drugs





好像要廢除了....
但是大部份藥物都還是這樣標示,所以還是可以參考....
Category A —
  • 孕婦研究無害
  • Studies in pregnant women have not shown an increased risk of birth defects.

Category B —
  • 孕婦研究無害但動物實驗有害,或
  • 孕婦沒有研究但動物實驗無害
  • Animal studies have revealed no evidence of harm to the fetus. However, there are no adequate studies in pregnant women.ORAnimal studies have shown an adverse effect, but adequate studies in pregnant women have failed to show a risk to the fetus.

Category C —
  • 孕婦沒有研究但動物實驗有害,或
  • 孕婦研究和動物實驗都沒有
  • Animal studies have shown an adverse effect and there are no adequate studies in pregnant women.ORNo animal studies have been conducted or there are no adequate studies in pregnant women.

Category D —
  • 孕婦研究有害,斟酌使用
  • Adequate studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of the drug may outweigh the potential risk.

Category X —
  • 孕婦研究或動物實驗有害,不該使用
  • Adequate studies in animals or pregnant women have shown evidence of birth defects. Women who are or may become pregnant should not use the drug.








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