Safety has not been established during pregnancy; benefit should outweigh risk.

AU TGA pregnancy category: B2
US FDA pregnancy category: C

Comments: This drug is known to interfere with absorption of fat-soluble vitamins even in the presence of vitamin supplementation and therefore, regular prenatal supplementation may not be adequate.

Animal studies have not been reported. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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

Use is considered acceptable; caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: This drug is not absorbed systemically, however, the possibility of interference with absorption of fat soluble vitamins should be considered as it may have an effect on nursing infants.

This drug is a nonabsorbable resin which does not enter the mother's blood stream and therefore will not reach the infant via breast milk.

See references