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Pregnancy Categories
FDA Classifications, Known Teratogens
| Item | Definition | Pregnancy Category/Consequence |
|---|---|---|
| FDA Pregnancy Category B | EITHER: Animal studies haven't shown risk to fetus AND No adequate, well-controlled studies in pregnant women. OR...Animal studies have shown adverse effect, but adequate, well-controlled studies in pregnant women didn't agree. | |
| FDA Pregnancy Category C | EITHER: Animal studies have shown adverse effect(s) on fetus, and there are no adequate, well-controlled human studies. OR: No animal OR human studies exist. | |
| FDA Pregnancy Category D | There IS evidence of human fetal risk (from investigational or marketing experience or human studies) but benefits might outweigh risks of use. | |
| FDA Pregnancy Category X | Animal or human studies have shown fetal abnormalities, OR investigational/marketing experience has shown the same; or both. AND, risk of use far outweighs benefit of use. | |
| ACEi's | (ACEi's) | C (1st tri), D (2nd & 3rd); major infant malformations (CV, CNS, renal, limb) |
| Aminopterin | folic acid-derivative (antineoplastic) | ? |
| Androgenic hormones | ? | ? |
| Busulfan | ? | ? |
| Chlorobiphenyls | ? | ? |
| Cigarette smoking | ? | ? |
| Cocaine | ? | ? |
| Coumarin anticoagulants | ? | ? |
| Cyclophosphamide | ? | ? |
| Diethylstilbestrol | ? | ? |
| Etretinate | ? | ? |
| Fluconazole (high doses) | ? | ? |
| Iodides | ? | ? |
| Accutane (isotretinoin) | ? | ? |
| lithium | ? | ? |
| Mercury (organic) | ? | ? |
| Methimazole | ? | ? |
| MTX | ? | ? |
| Methylene blue (via intraamniotic injection) | ? | ? |
| Misoprostol | ? | ? |
| Penicillamine | ? | ? |
| Phenytoin | ? | ? |
| Tetracyclines | ? | ? |
| Thalidomide | ? | ? |
| Toluene (abuse) | ? | ? |
| Trimethadione | ? | ? |
| Valproic acid | ? | ? |
| FDA Pregnancy Category A | Adequate, well-controlled studies in pregnant women haven't shown a risk to fetus in 1st trimester (and no evidence of risk in later trimesters exists). |