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Table 3 Effect of immunosuppressive, cytotoxic and biological drugs on human pregnancy and reproduction

From: Anti-inflammatory and immunosuppressive drugs and reproduction

Drug FDA riska Transplacental passage Human teratogenicity Fetal/neonatal adverse effects Long-term effects in offspring Impairment of fertility
Chloroquine/hydroxychloroquine C/C Yes No Not at recommended doses No impairment of vision or hearing Not studied
Sulphasalazine B Fetal like maternal serum concentration No Case reports of aplastic anaemia and neutropenia at >2 g maternal dose Not studied In men: oligospermia, decreased sperm motility, abnormal forms
Leflunomide X No data Data not conclusive None published Not studied Not studied
Azathioprine Mercaptopurine Db Yes No Sporadic congenital anomalies. Transient immune alterations in newborn infants Normal immune responses in childhood. One case report of late development of autoimmunity. No
Methotrexate X Methotrexate + polyglutamates Yes Cytopenia None reported Oligospermia at high doses
Cyclophosphamide D Yes – animal data Yes Chromosomal abnormalities. Cytopenia Anecdotal In males and females
Cyclosporine C 10–50% of maternal plasma concentration No Transient immune alterations None reported No
Tacrolimus C Yes Not reported Hyperkalaemia, renal impairment Not studied Not studied
Mycophenolate mofetil C Yes 3 reports of congenital abnormalities Not reported Not studied Not studied
Intravenous immunoglobulin C Yes No No fetal effects reported Not studied Not studied
Etanercept B Yes Not reported Not reported Not studied Not studied
Infliximab B Not reported Not reported Not reported Not studied Data not conclusive
  1. Details and references are given in the text. aThe United States Food and Drug Administration (FDA) pregnancy risk categories are as follows: A, no risk in controlled clinical studies in humans; B, human data reassuring or when absent, animal studies show no risk; C, human data are lacking; animal studies show risk or are not done; D, positive evidence of risk, benefit may outweigh; X, contraindicated during pregnancy. bAccumulated experience indicates that azathioprine can be used throughout pregnancy without increase in congenital abnormalities.