Is lurasidone (Latuda) safe for use during pregnancy in a woman of child‑bearing age who is stable on a low dose?

Lurasidone (Latuda) Safety in Pregnancy

Lurasidone can be continued during pregnancy for women who are stable and require ongoing treatment, as current evidence does not demonstrate an increased risk of major congenital malformations, though neonates require monitoring for transient extrapyramidal and withdrawal symptoms in the first 1-2 weeks after birth. 1, 2

Evidence-Based Safety Profile

Malformation Risk

• The absolute risk of major malformations with lurasidone exposure is 2.19%, compared to 1.77% in unexposed controls, yielding an odds ratio of 1.24 (95% CI = 0.36-4.32), which is not statistically significant 2
• No specific patterns of malformations have been identified in infants exposed to lurasidone 2
• Animal reproduction studies at doses up to 1.5 times (rats) and 6 times (rabbits) the maximum recommended human dose showed no teratogenic effects 1
• The FDA label explicitly states that lurasidone does not appear to be a major teratogen based on available data 1

Neonatal Adaptation Concerns

• Third-trimester exposure carries risk of transient neonatal symptoms including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding difficulties 1
• These symptoms typically begin within hours to days after birth and resolve within 1-2 weeks without long-term sequelae 1
• Some neonates recover without specific treatment; others may require prolonged hospitalization 1

Clinical Management Algorithm

During Pregnancy

• Continue lurasidone at the lowest effective dose if the patient is stable and requires ongoing treatment 1
• Be aware that lurasidone serum concentrations may decrease during pregnancy (ranging from 0-4.7 ng/mL during pregnancy versus 10-12 ng/mL postpartum in one case report), potentially necessitating dose increases to maintain therapeutic effect 3
• Monitor closely for worsening psychiatric symptoms, particularly after the second trimester when concentrations may drop further 3
• Enroll the patient in the National Pregnancy Registry for Atypical Antipsychotics (1-866-961-2388) 1

At Delivery and Postpartum

• Arrange for enhanced neonatal monitoring in the first 1-2 weeks after birth for extrapyramidal and withdrawal symptoms 1
• Monitor specifically for: respiratory distress, feeding difficulties, irritability, tremors, hypertonia, temperature instability, and hypoglycemia 1
• Recognize that symptoms may not be apparent at initial hospital discharge but can develop over the first week of life 1
• After delivery, lurasidone concentrations increase substantially, so the preconception dose may be adequate postpartum without further adjustment 3

Critical Pitfalls to Avoid

• Do not discontinue lurasidone abruptly upon discovering pregnancy—untreated severe mental illness poses significant risks to both mother and fetus, including poor prenatal care and impaired maternal functioning 4, 5
• Do not assume all second-generation antipsychotics have equivalent safety profiles—risperidone may carry a slightly higher malformation risk and is not considered first-line during pregnancy, whereas lurasidone, quetiapine, aripiprazole, and olanzapine have more reassuring data 4, 6
• Do not fail to arrange early postnatal follow-up—neonatal adaptation symptoms may emerge after initial hospital discharge 1
• Do not overlook the need for potential dose adjustments during pregnancy—physiologic changes may decrease drug concentrations and precipitate symptom relapse 3

Breastfeeding Considerations

• Lactation studies have not been conducted to assess lurasidone presence in human milk 1
• The decision to breastfeed should consider the mother's clinical need for lurasidone and weigh potential risks against the known benefits of breastfeeding 1
• Lurasidone is present in rat milk, suggesting it may transfer to human milk 1