Galantamine Pregnancy Warnings
Benefit should outweigh risk
AU TGA pregnancy category: B1
US FDA pregnancy category: C
Comments:
-Based on the indication for use, this drug is unlikely to be used in pregnant women.
Rats dosed at 2, 8, or 16 mg/kg/day from 14 days (females) or 60 days (males) prior to mating and continuing in females through organogenesis showed an increased incidence of fetal skeletal variations at the 2 highest doses. The lowest dose (2 mg/kg/day) did not show embryo-fetal toxicity in rats; this dose is approximately equal to the maximum recommended human dose (MRHD) on a mg/m2 basis. In rabbits dosed throughout the period of organogenesis, small increases in fetal visceral malformations and skeletal variations were observed at the highest doses; the dose not showing embryo-fetal developmental toxicity was approximately 20 times the MRHD. There are no controlled data in human pregnancy.
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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
See references
