FDA Pregnancy Catergories
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5 Terms
1
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Category A
Well-controlled studies in humans show no risk to the fetus.
2
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Category B
No well-controlled studies have been conducuted in humans; animal stdies show no risk to the fetus.
3
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Category C
No well-controlled studentis have been conducted in humans; animal studies have demonstrated an adverse effect on the fetus.
4
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Category D
Evidende of human risk to the fetus exists; however, benefits may outweigh risks in certain situations.
5
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Category X
[HIGH RISK] Controlled studies in animals or humans demonstrate fetal abnormalalites; the risk in pregnant women clearly outweighs any possible benefit.