Cabergoline Pregnancy Warnings
Use is not recommended unless clearly needed
AU TGA pregnancy category: B1
US FDA pregnancy category: B
Comments:
-Avoid use in pregnant patients with hypertension including preeclampsia, eclampsia, and postpartum hypertension unless potential benefit is judged to outweigh the possible risk.
-Pregnancy should be ruled out before starting therapy; women of child-bearing potential should be encouraged to use mechanical contraception during treatment.
-Women who are planning a pregnancy should discontinue this drug one month before intended conception.
In mice dosed at up to 8 mg/kg/day (approximately 55 times the maximum recommended human dose [MRHD]), maternotoxic, but not teratogenic effects were observed. In rats receiving approximately one-seventh MRHD during organogenesis, post-implantation embryofetal losses were observed, however these losses could have been due to the prolactin inhibitory properties of this drug in rats. In an observational study, pregnancy outcomes were followed over a 12-year period and included 256 pregnancies. Major congenital malformations or abortion were recorded in 17 (6.6%) pregnancies, and a total of 27 neonatal abnormalities occurred in 23 infants (both major and minor and included musculoskeletal malformations (10) and cardio-pulmonary abnormalities (5)). In the general population, the prevalence of major congenital malformations has been reported to be 6.9% or greater.
Due to the long half-life of this drug (up to 69 hours) and limited data on in utero exposure, this drug should be discontinued 1 month prior to intended conception. In women who conceive during treatment, the risk of abortion, premature delivery, multiple pregnancy, or congenital abnormalities does not appear to be increased. There are no adequate and well-controlled studies in pregnant women.
AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
See references
