Latuda (Lurasidone) Use During Lactation
Latuda should be avoided during breastfeeding due to insufficient safety data, and safer alternatives with established lactation profiles should be used instead.
FDA Labeling Position
The FDA label for lurasidone explicitly states that lactation studies have not been conducted to assess the presence of lurasidone in human milk, effects on the breastfed infant, or effects on milk production 1. While lurasidone is present in rat milk, there are no human data available 1.
Risk Assessment Framework
Key considerations when evaluating any medication during lactation:
- The development and health benefits of breastfeeding must be weighed against the mother's clinical need for lurasidone and any potential adverse effects on the breastfed infant 1
- All medications are excreted into breast milk to some extent, with the amount depending on drug characteristics, maternal pharmacokinetics, and dosing 2
- Most medications can be taken safely during breastfeeding, but potential risks of infant toxicity exist 2
Clinical Decision-Making Algorithm
When a lactating mother requires psychiatric medication:
First-line approach: Consider medications with established safety profiles during lactation, such as certain SSRIs (excluding fluoxetine and citalopram if starting postpartum) and TCAs (except doxepin) 3
For antipsychotics specifically: Use agents with more extensive lactation data rather than lurasidone, which lacks human studies 1
If lurasidone is deemed essential: The mother should discontinue breastfeeding given the absence of safety data 1
Important Caveats
Pediatric considerations from lurasidone studies:
- In pediatric trials, vomiting occurred at notably high rates (27% at 60mg dose in children 6-17 years), particularly in younger children ages 6-12 1
- One case of priapism occurred in a 10-year-old male, an adverse event not reported in adults 1
- These pediatric findings, while not directly applicable to breastfed infants, raise concerns about potential effects in vulnerable populations 1
General principles for medication use during lactation:
- Premature infants and those with neonatal diseases or inherited metabolic disturbances may be particularly vulnerable to drug exposure through breast milk 3
- Infant drug exposure is generally higher during pregnancy through placental passage than through breast milk 3
- The fundamental principle is risk-benefit assessment, with preference for drugs that are well-studied, minimally released in breast milk, or pose no apparent risk to infant health 4
Safer Alternatives
For mood disorders during lactation:
- SSRIs (excluding fluoxetine/citalopram if initiating postpartum) and most TCAs are compatible with breastfeeding 3
- For bipolar disorder, carbamazepine and sodium valproate are generally better tolerated by breastfed infants than lithium, though lithium should be avoided entirely 3
- Novel antipsychotics generally lack sufficient data, and clozapine should be avoided due to agranulocytosis risk 3
The absence of controlled trials and long-term follow-up studies for most psychotropic medications during lactation necessitates cautious prescribing practices 3. Given that lurasidone has zero human lactation data, it falls into the category where breastfeeding should be discouraged or discontinued if the medication is deemed necessary 4.