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Table 3 Disease-modifying antirheumatic drugs

From: Human pregnancy safety for agents used to treat rheumatoid arthritis: adequacy of available information and strategies for developing post-marketing data

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