TY - JOUR T1 - Paternal and maternal exposure to leflunomide: pregnancy and neonatal outcome JF - Annals of the Rheumatic Diseases JO - Ann Rheum Dis SP - 1096 LP - 1097 DO - 10.1136/ard.2004.030254 VL - 64 IS - 7 AU - M De Santis AU - G Straface AU - A Cavaliere AU - B Carducci AU - A Caruso Y1 - 2005/07/01 UR - http://ard.bmj.com/content/64/7/1096.abstract N2 - Leflunomide is a pyrimidine synthesis inhibitor with proven teratogenic and fetotoxic effects in animal studies, and its active metabolite is detectable in plasma up to 2 years after discontinuation of the drug.1–3 For this reason the fetus could have in utero exposure to leflunomide up to 2 years after the end of treatment unless an oral cholestyramine regimen, 8 g three times daily for 11 days, is administered to obtain undetectable plasmatic levels.1–3 Leflunomide has been classified as pregnancy category X by the Federal Drug Administration and the manufacturer recommends that for women of childbearing age “treatment with leflunomide must not be started until pregnancy is excluded and it has been confirmed that reliable contraception is being used”.1,4 Label instructions about paternal exposure recommend a … ER -