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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.