FDA Pregnancy Categories Flashcards
1
Q
Category A
A
Well-controlled studies have failed to demonstrate risk in the 1st trimester (no evidence of risk in later trimesters)
2
Q
Category B
A
Animal studies have failed to demonstrate risk, no adequate human studies
3
Q
Category C
A
Animal studies have shown an adverse effect on fetus, no adequate human studies, but the benefits may outweigh the risks
4
Q
Category D
A
Positive evidence of human fetal risk, but benefits may outweigh risks
5
Q
Category X
A
Human/animal studies show positive fetal risk, risks outweigh benefits
