Updated Guidance: Autoimmune Drug Safety in Pregnancy and Breastfeeding

Women are more likely than men to develop autoimmune diseases, and many are diagnosed during their reproductive years. Managing disease during pregnancy and breastfeeding requires careful balancing of maternal and fetal health. The 2024 update from the European Alliance of Associations for Rheumatology (EULAR) provides much-needed clarity: most standard treatments for autoimmune rheumatologic conditions are safe to use while trying to conceive, during pregnancy, and while breastfeeding.

Commonly used treatments like hydroxychloroquine, azathioprine, sulfasalazine, and TNF inhibitors (such as adalimumab and etanercept) can generally be continued safely. Most biologic therapies are also considered compatible with breastfeeding due to minimal transfer into breast milk.

However, certain medications should be avoided, including methotrexate, mycophenolate, and cyclophosphamide, as well as many newer oral treatments like JAK inhibitors (tofacitinib, upadacitinib) and apremilast, which either pose known risks or lack sufficient safety data. NSAIDs should be used sparingly and stopped after 28 weeks of pregnancy. These recommendations apply to a wide range of autoimmune rheumatic diseases, including lupus, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and systemic vasculitis.

Active autoimmune disease itself can harm pregnancy outcomes, so treatment plans should aim for remission or low disease activity throughout.

EULAR emphasizes shared decision-making and early, regular counseling to support both parent and child through every stage of reproductive health.

Citation

Rüegg, L., et al. (2025). EULAR recommendations for use of antirheumatic drugs in reproduction, pregnancy, and lactation: 2024 update. Annals of the Rheumatic Diseases. Advance online publication. https://doi.org/10.1016/j.ard.2025.02.023