Drug Safety

, Volume 29, Issue 10, pp 845–863 | Cite as

Disease-Modifying Antirheumatic Drugs in Pregnancy

Current Status and Implications for the Future
  • Fokaline Vroom
  • Hermien E. K. de Walle
  • Mart A. J. F. van de Laar
  • Jacobus R. B. J. Brouwers
  • Lolkje T. W. de Jong-van den Berg
Review Article


Drug use during pregnancy is sometimes unavoidable, especially in chronic inflammatory diseases such as rheumatoid arthritis (RA). The use of disease-modifying antirheumatic drugs (DMARDs) often starts in the early stage of RA; therefore, women of reproductive age are at risk for exposure to a DMARD at time of conception as well as during pregnancy. The aim of this paper was to review recent literature about DMARDs used for rheumatic diseases in pregnancy and to describe the type of study designs and results reported.

Twenty-nine studies; eight on hydroxychloroquine/chloroquine, thirteen on methotrexate, three on sulfasalazine and six on azathioprine were identified. With respect to hydroxychloroquine, most studies concluded that it could be safely used in systemic lupus erythematosus or RA. The same conclusions were drawn from the azathioprine studies, but the available evidence is scarce. Although the evidence regarding the safety of methotrexate during pregnancy is conflicting, a high rate of pregnancy losses indicates a risk to the fetus. For each individual case it must be decided whether the benefits outweigh the potential risks. No major teratogenic effects of sulfasalazine were seen although teratogenic effects still can not be excluded. For all other DMARDs, the information on their use in pregnancy was limited.

This review underscores the gross absence of data on safety and risks of DMARD use during conception and pregnancy. While young women use these drugs in pregnancy, this review stresses the importance of good monitoring and further research.


Infliximab Etanercept Sulfasalazine Leflunomide Hydroxychloroquine 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



No sources of funding were used in the preparation of this article. The authors have no conflicts of interest that are directly relevant to the content of this manuscript.


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Copyright information

© Adis Data Information BV 2006

Authors and Affiliations

  • Fokaline Vroom
    • 1
  • Hermien E. K. de Walle
    • 2
  • Mart A. J. F. van de Laar
    • 3
    • 4
  • Jacobus R. B. J. Brouwers
    • 1
    • 5
  • Lolkje T. W. de Jong-van den Berg
    • 1
  1. 1.Department of Social Pharmacy, Pharmacoepidemiology and PharmacotherapyGroningen University Institute for Drug Exploration (GUIDE)GroningenThe Netherlands
  2. 2.Department of Medical Genetics, EUROCAT Registration Northern NetherlandsUniversity Medical Centre GroningenGroningenThe Netherlands
  3. 3.Department of RheumatologyMedisch Spectrum TwenteEnschedeThe Netherlands
  4. 4.University TwenteEnschedeThe Netherlands
  5. 5.Department of Clinical Pharmacy & Clinical PharmacologyMedisch Centrum LeeuwardenLeeuwardenThe Netherlands

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