Is Seroquel (quetiapine) safe during breastfeeding?

Quetiapine (Seroquel) During Breastfeeding

Quetiapine can be used during breastfeeding with appropriate infant monitoring, as it transfers into breast milk in very low amounts (0.09% to 0.43% of the weight-adjusted maternal dose) with no reported adverse effects in the limited published literature. 1

Evidence from FDA Drug Labeling

The FDA label for quetiapine states that the drug is excreted into human milk, with published case reports showing breast milk levels ranging from undetectable to 170 μg/L 1. The estimated infant dose represents only 0.09% to 0.43% of the weight-adjusted maternal dose, with calculated infant daily doses ranging from less than 0.01 mg/kg (at maternal doses up to 100 mg daily) to 0.1 mg/kg (at maternal doses of 400 mg daily) 1. However, the FDA label recommends that "a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother's health" 1.

Clinical Safety Evidence

Despite the FDA's cautious language, clinical research supports quetiapine as one of the safer antipsychotic options during breastfeeding:

• Quetiapine is categorized as "acceptable" for breastfeeding based on available safety data and pharmacokinetic properties 2
• A 2014 review classified quetiapine as "safe, although monitoring is recommended" 3
• The very low infant exposure levels (less than 0.5% of maternal dose) suggest minimal risk to the breastfed infant 1

Practical Recommendations

If quetiapine is prescribed during breastfeeding, implement the following monitoring strategy:

• Use the lowest effective maternal dose 3
• Monitor the infant for increased sleepiness, poor feeding, decreased alertness, or any signs of sedation 4
• Watch for respiratory depression, though this is rarely reported with quetiapine exposure 3
• Consider more frequent monitoring if the infant is premature, has low birth weight, or has any underlying medical conditions 5

Important Caveats

The evidence base for quetiapine during breastfeeding has significant limitations:

• Data are based on a limited number of mother-infant pairs (N=8 in the FDA label) 1
• No long-term developmental outcome studies are available for infants exposed to quetiapine through breast milk 2
• Most evidence comes from case reports and small case series rather than prospective controlled studies 2

Risk-Benefit Considerations

The decision to continue quetiapine during breastfeeding should weigh:

• The critical importance of treating maternal psychiatric illness to prevent relapse, which poses significant risks to both mother and infant 6
• The substantial benefits of breastfeeding for infant development and maternal-infant bonding 6
• The very low drug exposure levels in breast milk compared to other antipsychotics 1, 2
• The availability of alternative antipsychotics (olanzapine is also considered acceptable) if concerns arise 2

Discontinuing breastfeeding solely due to quetiapine use is generally not necessary given the low infant exposure and absence of reported adverse effects in the published literature. 3, 2