Pregnancy safety categories and examples of immunosuppressive agents (adapted from FDA Consumer Magazine17).
| Category | Definition | Drug |
|---|---|---|
| A | Well controlled studies of pregnant women have failed to demonstrate fetal risk | |
| B | Animal reproduction studies have failed to demonstrate fetal risk and there are no well controlled studies in pregnant women | Infliximab Etanercept Adalimumab Certolizumab |
| C | Animal reproductive studies have shown an adverse fetal effect but there are no well controlled studies in humans; potential benefits may warrant use of the drug in pregnant women | Prednisone Hydroxychloroquine |
| D | There is positive evidence of human fetal risk based on data from investigational or marketing experience in humans; potential benefits may warrant use of the drug in pregnant women despite potential risks | Azathioprine |
| X | Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on investigational or marketing experience; the risks involved clearly outweigh potential benefits | Methotrexate Leflunomide |