Calcipotriene topical Pregnancy and Breastfeeding Warnings

Brand names: Calcitrene, Calsodore, Dovonex, Kalosar, Sorilux

Medically reviewed by Drugs.com. Last updated on Nov 13, 2023.

Calcipotriene topical Pregnancy Warnings

Use is not recommended unless clearly needed.

AU TGA pregnancy category: B1
US FDA pregnancy category: C

Animal studies have shown higher incidence of skeletal abnormalities consisting primarily of enlarged fontanelles and extra ribs. There are no adequate and well-controlled studies in pregnant women.

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

Calcipotriene topical Breastfeeding Warnings

AU: Benefit should outweigh risk.
UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
US: Caution is recommended.

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

Comments:
-The effects in the nursing infant are unknown.
-This drug should not be applied to the chest area during breastfeeding.

See references

Further information

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