Pregnyl (injectable) Pregnancy Warnings
Animal studies have reveal evidence of external congenital abnormalities, intrauterine deaths, impaired parturition, alterations in sex ratio, forelimb defects, and central nervous system defects. Multiple ovulations with plural gestations have been reported following treatment with this drug. There are no controlled data in human pregnancy.
AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
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 X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Human Chorionic Gonadotropin (HCG): Safety has not been established during pregnancy.
Recombinant Chorionic Gonadotropin (r-HCG): Use should be avoided.
AU TGA pregnancy category:
-HCG: A
-r-HCG B3
US FDA pregnancy category: X
Comment: Some experts recommend: HCG may be used for luteal phase support, but should not be used later in pregnancy.
See references
