Is Latuda (lurasidone) safe to use during the 1st trimester of pregnancy?

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Last updated: September 24, 2025View editorial policy

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Lurasidone (Latuda) Use During First Trimester of Pregnancy

Lurasidone should be used with caution during the first trimester of pregnancy, as there are limited safety data available, though recent registry data suggest it does not appear to be a major teratogen.

Safety Profile of Lurasidone in Pregnancy

The National Pregnancy Registry for Psychiatric Medications provides the most recent and relevant data on lurasidone use during pregnancy:

  • The absolute risk of major malformations with lurasidone exposure was 2.19% compared to 1.77% in controls (odds ratio 1.24,95% CI = 0.36-4.32) 1
  • No specific patterns of malformations were observed in infants exposed to lurasidone 1
  • Current data suggest lurasidone does not appear to be a major teratogen, though more data are needed to refine risk estimates 1

Considerations for First Trimester Use

When considering lurasidone use during the first trimester:

  1. Timing considerations:

    • The first trimester is the most critical period for potential congenital malformations due to organogenesis 2
    • If possible, medications should be avoided during this period unless benefits clearly outweigh risks
  2. Physiological changes:

    • Pregnancy can affect lurasidone concentrations
    • One case report showed decreased lurasidone serum concentrations during pregnancy compared to postpartum levels 3
    • This may necessitate dose adjustments to maintain efficacy

Decision-Making Algorithm

  1. Assess psychiatric stability and severity:

    • Determine if discontinuation would pose significant risk of relapse
    • Evaluate severity of the underlying condition (bipolar disorder, schizophrenia)
  2. Consider alternatives:

    • For medications with more established pregnancy safety profiles:
      • Some antipsychotics have more extensive pregnancy safety data
      • The lowest effective dose should always be used 2
  3. Risk-benefit analysis:

    • Weigh risks of untreated psychiatric illness against potential medication risks
    • Untreated severe psychiatric illness can pose significant risks to both mother and developing fetus

Monitoring Recommendations

If continuing lurasidone during first trimester:

  • Monitor for psychiatric symptom recurrence or worsening
  • Consider therapeutic drug monitoring if available, as pregnancy may decrease lurasidone concentrations 3
  • Regular prenatal care with increased fetal monitoring

Important Caveats

  • Lurasidone has a favorable metabolic and cardiovascular profile compared to some other antipsychotics 4, 5
  • This may be particularly relevant for pregnant women who are at increased risk for metabolic changes
  • The medication should be taken with food as directed, as this significantly affects absorption 4

Conclusion

While limited data are available on lurasidone use in the first trimester, the most recent evidence from the National Pregnancy Registry for Psychiatric Medications suggests it does not appear to be a major teratogen. The decision to use lurasidone during the first trimester should carefully weigh the risks of untreated psychiatric illness against the potential risks of medication exposure, with consideration of the patient's specific clinical situation and severity of illness.

References

Guideline

Management of Insomnia and Nausea/Vomiting During Pregnancy

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

Perinatal use of lurasidone for the treatment of bipolar disorder.

Experimental and clinical psychopharmacology, 2022

Research

Lurasidone: a clinical overview.

The Journal of clinical psychiatry, 2011

Research

Lurasidone (latuda®): an atypical antipsychotic.

Issues in mental health nursing, 2012

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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