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Medications and More during pregnancy and breastfeeding

Leflunomide (Arava®)

Selected References:

  • Alothman R, et al. 2023. Leflunomide exposure through second trimester of pregnancy: A case report. Birth Defects Res. 1;115(16):1566-1569. 
  • Arava Prescribing Information. 2021. Available online at https://products.sanofi.us/arava/arava.pdf [accessed February 2024].  
  • Bérard A, et al. 2018. Leflunomide use during pregnancy and the risk of adverse pregnancy outcomes. Ann Rheum Dis. 77(4):500-509.  
  • Brent RL. 2001. Teratogen update: Reproductive risks of leflunomide (Arava); A pyrimidine synthesis inhibitor: Counseling women taking leflunomide before or during pregnancy and men taking leflunomide who are contemplating fathering a child. Teratology. 63:106-112.  
  • Briggs G, et al. 2015. Leflunomide. Drugs in Pregnancy and Lactation, A reference Guide to Fetal and Neonatal Risk, 10th edition (pp 781—784). Philadelphia, PA: Wolters Kluwer Health. 
  • Cassina M, et al. 2012. Pregnancy outcome in women exposed to leflunomide before or during pregnancy. Arthritis Rheum. 64(7):2085-2094.  
  • Chakravarty EF, et al. 2003. The use of disease modifying antirheumatic drugs in women with rheumatoid arthritis of childbearing age: a survey of practice patterns and pregnancy outcomes. J Rheumatol. 30:241-246.  
  • Chambers CD, et al. 2010. Birth outcomes in pregnant women taking leflunomide. Arthritis Rheu. 62(5):1494-1503.  
  • Chambers CD, et al. 2007. Are new agents used to treat rheumatoid arthritis safe to take during pregnancy? Organization of Teratology Information Specialists (OTIS) study. Motherisk Update. 53(3):409-412.  
  • Chin A, et al. 2025. Recommendations for the use of disease-modifying antirheumatic drugs in pregnancy and reproductive health for patients with rheumatic disease: a scoping review. Arthritis care & research. 77(10):1273-1281. 
  • De Klaver PAG, et al. 2022. Leflunomide exposure and teriflunomide concentrations up to the third trimester of pregnancy: a case report. Clin Drug Invest. 42:787-789. 
  • De Santis M, et al. 2005. Paternal and maternal exposure to leflunomide: pregnancy and neonatal outcome. Ann Rheum Dis. 64:1096-1097. 
  • Hajdyla-Banas I, et al. 2009. Pregnancy course and neonatal outcome after exposure to leflunomide –2 cases report and review of literature. Przegl Lek. 66(12):1069-1071. 
  • Heine K & Peots CF. 2008. A pair of twins born after maternal exposure to leflunomide. J Perinatol. 28(12):841-842. 
  • Henson LJ, et al. 2020. Pregnancy outcomes in patients treated with leflunomide, the parent compound of the multiple sclerosis drug teriflunomide. Reprod Toxicol. 95:45-50.  
  • Karadag O, et al. 2013. Pregnancy outcomes of rheumatic patients with pre/peri gestational leflunomide exposure. Ann Rheum Dis. 72(Supp 3):A896-A897. 
  • Kraemer B, et al. 2008. A successful pregnancy in a patient with Takayasu’s asteritis. Hypertens Pregnancy. 27(3):247-252. 
  • Levy RA, et al. 2016. Critical review of the current recommendations for the treatment of systemic inflammatory rheumatic diseases during pregnancy and lactation. Autoimmun Rev. 15(10):955-963. 
  • Neville CE & McNally J. 2007. Maternal exposure to leflunomide  associated with blindness and cerebral palsy. Rheumatology (Oxford). 46(9):1506. 
  • Paulus W, et al. 2006. The use of leflunomide in fertile patients with rheumatoid arthritis [abstract]. Reprod Toxicol. 22:281.  
  • Pfaller B, et al. 2020. A critical review of the reproductive safety of leflunomide. Clin Rheumatol. 39(2):607-612. 
  • Princk C, et al. 2024. Use of leflunomide among girls and women of childbearing age and occurrence of leflunomide-exposred pregnancies in Germany. Reproductive Toxicology. 125:108573. 
  • Russell MD, et al. 2023. British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford, England). 62(4):e48-e88. 
  • Sammaritano LR, et al. 2020. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal  Diseases. Arthritis Care & Research. 72(4):461-488. 
  • Sayarlioglu M, et al. 2010. Maternal exposure to leflunomide and methotrexate in a patient with adult-onset Still’s disease. Rheumatology (Oxford). 49(9):1787-1789. 
  • Schaefer C, et al. 2015. Immunosuppression, rheumatic diseases, multiple sclerosis, and Wilson’s disease: Leflunomide. In: Drugs during pregnancy and lactation: Treatment options and risk assessment, 3rd ed (pp 362-363)(pp 658-659). London: Academic Press. 
  • Song Y, et al. 2024. Medication utilization trends during pregnancy and factors influencing adverse pregnancy outcomes in patients with rheumatoid arthritis. RMD Open. 10(1):e003739. 
  • Viktil KK, et al. 2012. Outcomes after anti-rheumatic drug use before and during pregnancy: a cohort study among 150,000 pregnant women and expectant fathers. Scand J Rheumatol. 41(3):196-201. 
  • Weber-Schoendorfer C, et al. 2017. Leflunomide – A human teratogen? A still not answered question. An evaluation of the German Embryotox pharmacovigilance database. Reprod Toxicol. Aug;71:101-107.

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