很多醫療人員都曉得這個懷孕分級,但其實對真正的定義和全文卻是很清楚,現在提供給大家作為參考
Category
|
Interpretation
|
A
|
Controlled studies show no risk
|
Adequate, well-controlled studies in pregnant women have failed to demonstrate risk to the fetus
|
|
B
|
No evidence of risk in humans
|
Either animal findings show risk (but human findings do not) or, if no adequate human studies have been done, animal findings are negative.
|
|
C
|
Risk cannot be ruled out
|
Human studies are lacking and animal studies are either positive for fetal risk or lacking as well. However, potential benefits may justify the potential risk.
|
|
D
|
Positive evidence of risk
|
Investigational or postmarketing data show risk to fetus. Nevertheless, potential benefits may outweight the risk.
|
|
X
|
Contraindicated in pregnancy
|
Studies in animals or humans, or investigational or postmarketing reports have shown fetal risk which clearly outweighs any possible benefit to the patient.
|
中文解說:FDA懷孕用藥分級
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