Polidocanol Pregnancy and Breastfeeding Warnings

Brand names: Asclera, Varithena

Medically reviewed by Drugs.com. Last updated on Oct 17, 2023.

Polidocanol Pregnancy Warnings

Use is not recommended.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Administration of this drug IV injection at doses greater than or equal to 2.5 mg/kg to pregnant rabbits once daily from gestation day 6 to 14 to 18 was associated with increased resorptions, fetal malformations (mainly of the limbs and head) and fetal death. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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 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.

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Polidocanol Breastfeeding Warnings

Use is not recommended unless benefit outweighs risk.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

This drug and/or its metabolites were found in the milk of lactating rats for at least 48 hours after a single IV dose. Administration at IV doses up to 10 mg/kg (about 80% of the maximum human dose based on body surface area) to lactating rats had no effect on offspring development.

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Further information

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