Safinamide Pregnancy and Breastfeeding Warnings

Brand names: Xadago

Medically reviewed by Drugs.com. Last updated on Jul 10, 2023.

Safinamide Pregnancy Warnings

Not recommended

AU TGA pregnancy category B3
US FDA pregnancy category: C

Comments:
-This drug should only be used during pregnancy if the potential benefit justifies the potential benefit to the fetus.
-Women of childbearing should be advised not to become pregnant.

Teratogenicity has been observed in animal studies with clinically relevant doses; developmental toxicity was observed at lower doses when administered in combination with levodopa/carbidopa. Pre and postnatal developmental studies in rats have shown pup mortality, absence of milk in the stomach, and neonatal hepatotoxicity at dose levels similar to anticipated clinical exposure. There is no clinical data on exposed pregnancies nor any controlled studies in pregnant women.

Fertility studies in female rats have shown reduced number of implantations and corpora lutea at exposures in excess of 3 times the anticipated human exposure. Male rats showed minor abnormal morphology and reduced speed of sperm cells at exposures in excess of 1.4 times the anticipated human exposure. Male rat fertility was not affected. The clinical relevance of these findings is unknown.

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.

See references

Safinamide Breastfeeding Warnings

Rat pups indirectly exposed to this drug via milk during the lactation period experienced skin discolorations presumed to be caused by hyperbilirubinemia.

Not recommended

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

Comments: A decision should be made to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

See references

Further information

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