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Paternal and maternal exposure to leflunomide: pregnancy and neonatal outcome
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  1. M De Santis,
  2. G Straface,
  3. A Cavaliere,
  4. B Carducci,
  5. A Caruso
  1. Telefono Rosso-Teratology Information Service. Department of Obstetrics and Gynaecology, Catholic University of the Sacred Heart, Rome, Italy
  1. Correspondence to:
    Dr M De Santis
    Telefono Rosso-Teratology Information Service, Department of Obstetrics and Gynaecology, Catholic University of the Sacred Heart, Largo A Gemelli, 8 00168 Rome, Italy; marcodesantisrm.unicatt.it

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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 …

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