Is Latuda (lurasidone) safe to use while breastfeeding?

Latuda (Lurasidone) Use During Breastfeeding

Latuda is not recommended for use while breastfeeding due to insufficient safety data and lack of studies demonstrating its safety in nursing infants.

FDA Labeling and Safety Information

• The FDA label explicitly states that "lactation studies have not been conducted to assess the presence of lurasidone in human milk, the effects on the breastfed infant, or the effects on milk production" 1
• Lurasidone is present in rat milk, suggesting likely transfer into human breast milk 1
• The FDA recommends that "the development and health benefits of breastfeeding should be considered along with the mother's clinical need for lurasidone hydrochloride tablets and any potential adverse effects on the breastfed infant" 1

Expert Clinical Recommendations

• A 2013 systematic review of antipsychotic drugs during breastfeeding specifically categorized lurasidone as "not recommended" for breastfeeding mothers 2
• This recommendation was based on the absence of any published data on infant exposures to lurasidone through breast milk 2
• The review emphasized that for most antipsychotic drugs, including lurasidone, "a firm and evidence-based conclusion cannot be reached" due to limited infant exposure data 2

Risk Assessment Considerations

• When evaluating medication safety during breastfeeding, the amount transferred to breast milk depends on maternal serum concentration and pharmacologic properties of the medication 3
• Risk assessment should balance the drug's potential risk to the infant against the benefits of breastfeeding, risks of untreated maternal disease, and maternal willingness to breastfeed 4
• Priority should be given to effectively treating the mother's mental health condition, but preferably with medications that have established safety profiles during breastfeeding 3

Alternative Approaches

• If treatment for bipolar depression is needed during breastfeeding, consultation with a psychiatrist to identify antipsychotic medications with better-established safety profiles is essential 2
• Among antipsychotic medications, olanzapine and quetiapine have been categorized as "acceptable" for breastfeeding based on available safety data 2
• Chlorpromazine, haloperidol, risperidone, and zuclopenthixol are categorized as "possible under medical supervision" 2

Critical Clinical Caveats

• The decision to use any medication during breastfeeding should involve consultation with the infant's pediatrician 5
• If a mother taking lurasidone chooses to breastfeed despite recommendations, the infant requires close monitoring for sedation, feeding difficulties, and developmental concerns 3, 4
• Mothers should be counseled that discontinuing breastfeeding to safely use necessary psychiatric medication is a medically appropriate decision when safer alternatives are not effective 4
• Do not advise discontinuation of effective psychiatric treatment without first identifying a safer alternative that will adequately control the mother's condition 3, 4