Table 3 Disease-modifying antirheumatic drugs
Agent | FDA pregnancy category | Adverse effects in human pregnancy | Summary risk assessment |
|---|---|---|---|
Methotrexate | X | Pattern of malformation, including apparent dose-related abnormalities of growth, craniofacies, limb development, and neurodevelopment | Based on available data, contraindicated in human pregnancy; unknown magnitude of risk |
Sulfasalazine | B | Possible increased risk for malformations suggested in two studies; other studies negative | Based on limited data, a substantial teratogenic risk is unlikely |
Leflunomide | X | No documented increased risk for structural defects in humans | Based on minimal data in human pregnancy, teratogenic risk is undetermined |
Hydroxychloroquine | C | No documented increased risks for malformations; theoretical concerns for retinal toxicity and ototoxicity, but no reported cases | Although data are insufficient, a substantial teratogenic risk is unlikely |
Azathioprine | D | No documented increased risk for structural defects; growth and gestational age effects may be related to transplant status | Although data are limited, a substantial risk for structural malformations is unlikely |
Cyclosporine | C | No documented increased risk for structural defects; growth and gestational age effects may be related to transplant status | Based on limited data, risk for structural malformations is unlikely |
Chlorambucil | D | Case reports only – two with unilateral renal agenesis | Based on insufficient data, teratogenic risk is undetermined |
Cyclophosphamide | D | Pattern of malformation including increased risk for abnormalities of growth, craniofacies, limb development, and neurodevelopment | Based on available data, contraindicated in human pregnancy; unknown magnitude of risk |