Colesevelam hydrochloride does not cause maternal or fetal toxicity in rats and rabbits

Pre- and postnatal effects were assessed in pregnant rats receiving 100, 300 or 1000 mg/kg/day colesevelam from GD 6 to postpartum day 22. Gestation, parturition and lactation in F0 generation dams were similar between treatment and control groups. Colesevelam did not affect physical or neurological development or induce gross pathological changes in F1 generation rats. Colesevelam does not produce developmental toxicity in rats or rabbits, nor does it exhibit pre- or postnatal toxicity in rats at the tested doses.