Zuranolone Pregnancy and Breastfeeding Warnings

Brand names: Zurzuvae

Zuranolone Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on findings from animal studies, the drug can cause fetal harm when administered to a pregnant woman.

Comments:
-The data available is insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
-Patients should be apprised of potential risks to the fetus.
-Women of childbearing potential should be encouraged to use effective contraception during treatment and for 1 week after the final dose.
-A pregnancy exposure registry is available.

Animal studies have revealed evidence of embryofetal toxicity and teratogenicity. In pregnant rats administered this drug during organogenesis, developmental toxicity occurred at an oral dose associated with maternal plasma exposure and similar to the maximum recommended human dose of 50 mg. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a National Pregnancy Registry for Antidepressants has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/

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 healthcare 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.

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Zuranolone Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Yes

Comments:
-This drug would not be expected to cause any adverse effects on breastfed infants due to its low concentration in milk.
-The use of this drug during breastfeeding should be monitored carefully for excessive sedation by the infant, especially in newborns and preterm babies.
-There are no data available on the effects of this drug on breastfed infants and limited data on the effects on milk production.

A small study reported that after oral administration of 30 mg of this drug once a day for 5 days, nursing infants received less than 1% of the weight-adjusted maternal dose. The concentration of this drug in breast milk was below the level of quantification limit by 4 to 6 days after the last dose.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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