Skip to Content

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: Not assigned. Comments: -A pregnancy exposure registry is available. -If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus. -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. To monitor the outcomes of pregnant women exposed to atypical antipsychotics, a National Pregnancy Registry for Atypical Antipsychotics has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/atypicalantipsychotic/. 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 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.

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 Comment: 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. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide