MCC PARAMEDIC - FDA Pregnancy Categories

Category A

Adequate studies in pregnant women have failed to show a risk to the fetus in the first trimester and there is no evidence of risk in later trimesters.

Category B

Animal studies have failed to show a risk to the fetus but there are no adequate studies in pregnant women: or animal studies have shown an adverse effect but human studies have not shown a risk to the fetus in the first trimester and there is no evidence of risk in later trimesters.

Category C

Animal studies have shown an adverse effect on the fetus but there are no adequate studies in humans, but the benefits may outweigh the risks; or there are no aminal studies and no adequate human studies.

Category D

Positive evidence of human fetal risk but the benefits may outweigh the risks.

Category X

Animal or human studies have shown fetal abnormalities or toxicity, and the risk outweighs the benefits.

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