Skip to Content

Safinamide Pregnancy and Breastfeeding Warnings

Safinamide is also known as: Xadago

Medically reviewed on July 20, 2017

Safinamide Pregnancy Warnings

Not recommended

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 animals show exposure to this drug is associated with adverse reactions on female rat reproductive performance and sperm quality; male rat fertility was not affected.

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

References for pregnancy information

  1. "Product Information. Xadago (safinamide)." US WorldMeds LLC, Louisville , KY.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Xadago (safinamide)." US WorldMeds LLC, Louisville , KY.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide