The aim of this prospective, observational study was to assess transplacental transmission of
ketanserin, an
antihypertensive drug used in
pre-eclampsia, and to determine disposition and effects in the neonate after maternal
ketanserin use. In 22 pregnant women with severe
pre-eclampsia, admitted to the antenatal ward in the period 1999-2001, the ratio of
drug levels in the umbilical cord to
drug levels in maternal blood just before delivery was used as an
indicator of placental transmission. Disposition of
ketanserin was assessed using neonatal plasma concentrations of
ketanserin in eight neonates after birth. A median placental transmission was found in the pre-eclamptic women of 0.95 (0.612-1.24) for
ketanserin and for its metabolite,
ketanserinol, of 0.60 (0.5-0.77). Pharmacologically relevant concentrations of
ketanserin were found in the neonate after delivery. The elimination half-life of
ketanserin in the neonate varied between 12.7 and 43.7 hours (median 19.3 hours) and of
ketanserinol between 13.8 and 34.4 hours (median 18.7 hours). Despite the high placental transmission and disposition in the neonate, no apparent adverse effects in the neonates could be detected. In conclusion, a high placental transmission of
ketanserin and its metabolite
ketanserinol occurred after maternal treatment of
pre-eclampsia with
ketanserin and pharmacologically active concentrations of
ketanserin are found in the neonate for a prolonged period after delivery.