|
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 |
Chambers et al. Arthritis Research & Therapy 2006 8:215 doi:10.1186/ar1977 |
|||