|
A |
Adequate and well-controlled studies in pregnant women have failed to demonstrate fetal risk |
|
B |
Animal reproduction studies have failed to demonstrate fetal risk and there are no adequate and well-controlled studies in pregnant women OR an adverse effect have been demonstrated in animal reproduction studies, but adequate and wellcontrolled studies in pregnant women have failed to demonstrate fetal risk |
| C |
An adverse effect on the fetus has been shown by animal reproduction studies, but the benefits from the use may be acceptable despite its potential risks in pregnant women OR no animal reproduction studies and no adequate and well controlled studies in humans |
|
D |
Positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks |
|
X |
Studies in animals or humans have demonstrated fetal abnormalities, or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, AND the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit |
| FDA: US Food and Drug Administration. Adapted from 21 Code of Federal Regulations (CFR) 201.57 (f) (2007) |
