title: Safety considerations when prescribing immunosuppression medication to pregnant women.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of Milan, Ospedale Gaetano Pini, Division of Rheumatology, Department of Clinical Sciences and Community Health , via Pini 9, 20122 Milan , Italy +390258296719 ; +390258296315 ; maria.gerosa@unimi.it.
authors.forename: Maria
authors.initials: M
authors.lastname: Gerosa
authors.forename: Pier Luigi
authors.initials: PL
authors.lastname: Meroni
authors.forename: Rolando
authors.initials: R
authors.lastname: Cimaz
mesh_terms: D000818:Animals; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D011247:Pregnancy; D012216:Rheumatic Diseases / Q000188:drug therapy
chemical_list: D007166:Immunosuppressive Agents
keywords: TNF inhibitors; azathioprine; biological agents; cyclosporine; immunosuppressive drugs; leflunomide; methotrexate; mycophenolate mofetil; pregnancy; steroids