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Lurasidone Pregnancy and Breastfeeding Warnings

Lurasidone is also known as: Latuda

Lurasidone Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B1 US FDA pregnancy category: B Comments: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and /or withdrawal symptoms following delivery.

Agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates exposed to antipsychotics during the third trimester of pregnancy; cases have varied widely in severity from self-limited to reports of neonates who have required intensive support and prolonged hospitalization. In animal studies in doses up to 25 mg/kg/day (rats) and 50 mg/kg/day (rabbits), corresponding to 1.5 and 5 times the maximal recommended human dose, respectively, teratogenicity was not observed. Studies in rats at doses up to 10 mg/kg/day did not show an effect on delivery or pup development when dosed from early gestation to weaning. There are no controlled data in human pregnancy. 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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Lurasidone Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Latuda (lurasidone)." Sunovion Pharmaceuticals Inc, Marlborough, MA.

References for breastfeeding information

  1. "Product Information. Latuda (lurasidone)." Sunovion Pharmaceuticals Inc, Marlborough, MA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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