Quetiapine Pregnancy and Breastfeeding Warnings
Quetiapine Pregnancy Warnings
Quetiapine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryo, fetal, and maternal toxicity. There are no controlled data in human pregnancy. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Quetiapine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
There have been several case reports of women giving normal birth to healthy infants following exposure to quetiapine throughout pregnancy.
Quetiapine Breastfeeding Warnings
In 1 case report, the mean milk quetiapine concentration was 41 mcg/L and the milk:plasma ratio was 0.29 in a mother receiving 400 mg of quetiapine daily. The relative infant dose was 0.09% of the maternal weight- adjusted dose. The infant plasma quetiapine concentration was 1.4 mcg/L which was equivalent to 6% of the maternal plasma level. No adverse effects were observed in the infant. Results of a small case series suggest that at quetiapine dosing levels of 75 mg daily or less, the amount of drug excreted into breast milk may be below detectable levels. Assuming an average infant ingests 150 mL/kg/day of breast milk and using an average milk concentration of quetiapine over 6 hours an exclusively breastfed infant ingests approximately 0.09% of the weight- adjusted maternal dose. Based on these calculations, the maximum dose an infant would ingest is approximately 0.43% of the weigh- adjusted maternal dose. The average milk concentration of quetiapine over 6 hours was approximately 14 mcg/L and the maximum concentration was approximately 62 mcg/L at 1 hours. Levels of quetiapine rapidly decreased to predose levels within approximately 2 hours. There are 2 case reports of healthy infants of breastfed mothers receiving quetiapine.
Quetiapine is excreted into human milk. The manufacturer has recommended that women receiving this drug should not breast-feed.
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