Safety considerations when prescribing immunosuppression medication to pregnant women

Maria Gerosa, Pier Luigi Meroni, Rolando Cimaz

Research output: Contribution to journalArticlepeer-review


Introduction: In the past two decades, the number of women with autoimmune and inflammatory diseases experiencing a pregnancy has significantly increased in parallel with the enormous advances in the diagnosis and management of these disorders. However, information regarding the safety of immunosuppressive agents comes from case reports and case series and no controlled trials are available.Areas covered: We performed a review of the literature using MEDLINE. The term 'pregnancy' was searched in combination with all the principal immunomodulant/immunosuppressive drugs used in rheumatic diseases.Expert opinion: A large number of reports suggest that azathioprine, cyclosporine, hydroxychloroquine and steroids are relatively safe during pregnancy, whereas methotrexate, cyclophosphamide, mycophenolate mofetil and leflunomide are contraindicated. Data about the safety of biological agents are scant, but a growing number of publications suggest that at least TNF inhibitors could be prescribed when benefits outweigh the potential risks. Nevertheless, we cannot draw definite conclusions, as this information has not been confirmed in controlled trials. Prospective registries, some of which are already in place, are invaluable resources to answer many questions, especially on the incidence of fetal malformations. Finally, outcome studies on the offspring especially in regard to immune system and psychomotor development will shed light on long-term safety.

Original languageEnglish
Pages (from-to)1591-1599
Number of pages9
JournalExpert Opinion on Drug Safety
Issue number12
Publication statusPublished - Dec 1 2014


  • Azathioprine
  • Biological agents
  • Cyclosporine
  • Immunosuppressive drugs
  • Leflunomide
  • Methotrexate
  • Mycophenolate mofetil
  • Pregnancy
  • Steroids
  • TNF inhibitors

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine(all)


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