Table 1. US Food and Drug Administration pregnancy category of immunosuppressive drugs for systemic inflammatory diseases.
Description | Non-biologic immunosuppressive Drugs |
Biologic immunosuppressive drugs |
|
---|---|---|---|
A | Adequate and well-controlled human studies fail to show a fetal risk |
None | None |
B | Animal studies fail to show a fetal risks and there are no human studies |
Sulfasalazine, mesalamine A |
Adalimumab, alefacept, anakinra, certolizumab, etanercept, golimumab, infliximab, ustekinumab |
C | Animal studies show a fetal risk and there are no adequate human studies |
Cyclosporine, gold, hydroxychloroquine b, tacrolimus |
Abatacept, natalizumab, rituximab, tocilizumab |
D | There is evidence of fetal risk, but the benefits may outweigh the risks |
Azathioprine, cyclophosphamide, D-penicillamine, mercaptopurine, mycophenolate |
|
X | There is evidence of fetal risk and the risks clearly outweigh any possible benefits |
Leflunomide, Methotrexate |
sacol is in category C,
not officially classified