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Leflunomide (Arava®)

Selected References:

  • Arava Prescribing Information. Available online at http://products.sanofi.us/arava/arava.html [accessed Dec 2015].
  • 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):2085-94.
  • 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.
  • De Santis M, et al. 2005. Paternal and maternal exposure to leflunomide: pregnancy and neonatal outcome. Ann Rheum Dis, 64:1096-1097.
  • Henson LJ, et al. 2020. Pregnancy outcomes in patients treated with lefunomide, the parent compound of the multiple sclerosis drug teriflunomide. Reprod Toxicol, 95:45-50.
  • 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.
  • 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.
  • 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.