The goal of this article is to assess the reproductive safety of caber
goline, a new ergot derivative proposed in hyperprolactinemic disorder
s, Investigated in different animal species, the drug showed no terato
genic or embryotoxic effects on rabbits, Considering the dose envisage
d for humans, large safety margins exist. Our sample consists of 226 p
regnancies occurring in 205 women, Follow-up is available for 204. The
re were 24 miscarriages and three abortions induced because of major m
alformations (one Down syndrome in a 42-year-old woman, one limb-body
wall complex, one hydrocephalus), Two of the 148 single liveborn infan
ts had significant malformations: one megaureter, one scaphocephaly, T
his series shows no increase in miscarriage rate, a distribution of bi
rthweights and sex ratio within the expected range, and no increased r
ate of congenital malformations, Follow-up of babies, limited to 107 c
ases, thus far indicates normal physical and mental development.