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 performed, animal findings are negative |
C |
Risk cannot be ruled out |
Human studies are lacking, and results of 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 post-marketing data show risk to the fetus. Nevertheless, potential benefits may outweigh the potential risk |
X |
Contraindicated in pregnancy |
Studies in animals or humans, or investigational or post-marketing reports, have shown fetal risk that clearly outweighs any possible benefit to the patient |