Is quetiapine (Seroquel) safe during breastfeeding?

Quetiapine (Seroquel) and Breastfeeding

Quetiapine is generally considered safe for breastfeeding, with infant exposure representing less than 0.5% of the weight-adjusted maternal dose and minimal risk to the breastfed infant.

Key Safety Data

Infant Exposure Levels

• Quetiapine transfers into breast milk at very low concentrations, with milk levels ranging from undetectable to 170 μg/L 1
• The estimated infant dose ranges from 0.09% to 0.43% of the weight-adjusted maternal dose, which represents minimal exposure 1, 2
• Calculated infant daily doses range from less than 0.01 mg/kg (at maternal doses up to 100 mg) to 0.1 mg/kg (at maternal doses of 400 mg) 1
• The milk-to-plasma ratio averages 0.29 to 0.47, indicating limited drug transfer into breast milk 2, 3

Clinical Recommendations

The American Academy of Pediatrics recommends monitoring the infant for:

• Increased sleepiness or sedation 4
• Poor feeding 4
• Decreased alertness 4

These monitoring recommendations are precautionary, as actual adverse events in breastfed infants have not been reported in published literature 2, 5, 6, 3.

Evidence Quality and Consensus

Guideline-Based Recommendations

• Quetiapine is categorized as "acceptable" for breastfeeding in systematic reviews of antipsychotic safety during lactation 6
• Other sources classify it as "safe, although monitoring is recommended" 5

Research Support

• Multiple pharmacokinetic studies confirm extremely low infant exposure levels 2, 3
• A study of 9 lactating women taking quetiapine (mean dose 41 mg/day) found no adverse effects in any exposed infants 2
• Infant plasma concentrations were only 6% of corresponding maternal plasma concentrations, demonstrating minimal systemic absorption 3

Clinical Decision-Making Algorithm

For mothers requiring quetiapine during breastfeeding:

1. Proceed with breastfeeding while taking quetiapine, as benefits likely outweigh minimal risks 6, 3

2. Use the lowest effective dose to minimize infant exposure 1

3. Monitor the infant regularly for:

   • Sedation or excessive sleepiness 4
   • Adequate feeding and weight gain 4
   • Normal alertness and responsiveness 4

4. Consider measuring quetiapine levels in breast milk or infant plasma if concerns arise, though this is not routinely necessary 3

Important Caveats

FDA Labeling Considerations

• The FDA label states that "a decision should be made whether to discontinue nursing or to discontinue the drug" 1
• However, this conservative language reflects regulatory caution rather than evidence of harm, as no serious adverse reactions have been documented in breastfed infants 2, 5, 6, 3

Comparison to Other Antipsychotics

• Quetiapine demonstrates more favorable safety data than chlorpromazine or clozapine, which may induce developmental concerns 5
• It is comparable in safety to olanzapine and risperidone for breastfeeding mothers 5, 6

Maternal Mental Health Priority

Maintaining maternal psychiatric stability is crucial for both mother and infant wellbeing 1, 6. The extremely low infant exposure levels support continuing both quetiapine treatment and breastfeeding when clinically indicated.