Famotidine Pregnancy Warnings
Use is recommended only if clearly needed and the benefit outweighs the risk.
AU TGA pregnancy category: B1
US FDA pregnancy category: B
Animal models have failed to reveal evidence of teratogenicity or changes in fertility. This drug crosses the placenta. Sporadic abortions occurred in an animal model at maternotoxic doses. 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 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.
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Famotidine Breastfeeding Warnings
Animal models have revealed transient growth depression when mothers were given maternally toxic doses (at least 600 times the usual human dose).
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Yes
Comment:
-Some experts state that use is contraindicated during breastfeeding.
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