Mezavant XL Use In Pregnancy & Lactation

Pregnancy: There is limited experience with mesalazine in pregnancy. Mesalazine crosses the placental barrier, but provides foetal concentrations much lower than those seen with adult therapeutic use. Animal studies do not indicate harmful effects of mesalazine in pregnancy, embryonal/foetal development, parturition or postnatal development. Adverse outcomes (including disturbances in blood counts such a leukopenia, thrombocytopenia, and anemia) were reported in infants born to mothers who were exposed to mesalazine during pregnancy. Mesalazine should be used during pregnancy only when the benefits outweigh the risks. Caution should be exercised when using high doses of mesalazine.
Congenital malformations and other adverse outcomes (including one event of hydrops fetalis and fetal anemia in one infant) were reported in infants born to mothers who were exposed to mesalazine during pregnancy. Mezavant should only be used during pregnancy if the benefits outweigh the risks.
Breast-feeding: Mesalazine is excreted in breast milk at low concentration. Acetylated form of mesalazine is excreted in breast milk at higher concentration. Caution should be exercised if using Mesalazine while breast-feeding and only if the benefit outweighs the risks. Sporadically acute diarrhoea has been reported in breast fed infants.
Fertility: Data on mesalazine show no sustained effect on male fertility.