Fareston Pregnancy Warnings
In animal studies, this drug crossed the placenta and accumulated in the fetus. These studies showed doses significantly less than the daily maximum recommended human dose resulted in maternal toxicity, increased pre-implantation loss, increased resorptions, reduced fetal weight, fetal anomalies, and impairment in fertility and conception. Additionally, this drug may cause diethylstilbestrol (DES)-like effects (i.e., vaginal adenosis) in offspring like other drugs in this class. There are no controlled data in human pregnancy.
AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
AU: Use of this drug during pregnancy is contraindicated.
UK, US: Use of this drug is not recommended during pregnancy.
AU TGA pregnancy category: B3
US FDA pregnancy category: D
Comments: Based on its mechanism of action in humans and animal study findings of increased pregnancy loss and fetal malformation, this drug may cause fetal harm when administered to a pregnant woman.
See references
