Foscarbidopa / foslevodopa Pregnancy and Breastfeeding Warnings

Brand names: Vyalev

Medically reviewed by Drugs.com. Last updated on Jan 17, 2025.

Foscarbidopa / foslevodopa Pregnancy Warnings

According to some authorities: Use is not recommended during pregnancy and in women of childbearing potential not using contraception unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not Assigned

Comments:
-There are no data available on use of this drug in pregnant women to inform a drug-related risk.

Animal studies have revealed evidence of teratogenicity. Carbidopa-Levodopa has been shown to be developmentally toxic at clinically relevant doses. Administration of this drug to pregnant rabbits during the period of organogenesis resulted in both visceral and skeletal malformations in fetuses at all doses and ratios of carbidopa or levodopa tested; in rats there was a decrease in the number of live births. No teratogenic effects were observed in mice. No effects on fertility were observed in animal studies. There are no controlled data in human pregnancy.

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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Foscarbidopa / foslevodopa Breastfeeding Warnings

According to some authorities: Use is not recommended.

Excreted into human milk: Unknown (carbidopa); Yes (levodopa and possibly its metabolites)
Excreted into animal milk: Yes (carbidopa)

Comments:
-Foscarbidopa and foslevodopa are converted to carbidopa and levodopa in vivo, respectively.
-There are no adequate data on the presence of this drug in human milk or the effects of this drug on milk production.
-Levodopa may suppress lactation.
-According to some experts, limited data on the use of levodopa during breastfeeding suggest that:
---Levodopa is poorly excreted into breast milk.
---Serum prolactin is decreased during treatment with levodopa.
---Some mother-infant pairs were able to breastfeed successfully without apparent harm while using low doses of carbidopa/levodopa.
-Developmental and health benefits of breastfeeding should be considered, as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

Further information

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