Is Paroxetine safe while breastfeeding?

Effects on the breastfed infant

Agitation and difficulty feeding in one infant (age and other details not reported) that were possibly related to paroxetine in breastmilk were reported to the Australian Adverse Drug Reaction Advisory Committee.[ 18 ] In a controlled cohort study of mothers who took paroxetine during pregnancy (diagnoses not reported), 36 mothers took paroxetine during the third trimester and breastfed their infants. Of these, 8 reported side effects in their infants including alertness (6), constipation (3), sleepiness (1), and irritability (1). There were no reports of side effects in the control group of mothers who breastfed and did not use paroxetine in the third trimester or during nursing. The relative contribution of transplacental and breastmilk acquisition of the drug could not be determined.[ 19 ] In a study comparing the infants of mothers who took an SSRI during pregnancy for major depression with the infants of depressed mothers who did not take an SSRI, mental development and most motor development was normal at follow-up averaging 12.9 months in both groups. Four of the treated mothers took paroxetine in doses averaging 28.6 mg daily for an average of 7.8 months while breastfeeding (extent not stated) their infants. Psychomotor development was slightly delayed compared to controls, but the contribution of breastfeeding to abnormal development could not be determined.[ 20 ] A prospective cohort study evaluated 27 infants whose mothers took paroxetine (diagnoses not reported) at an average dose of 20.7 mg daily for at least 2 weeks during breastfeeding (extent not stated). Two control groups consisted of two groups of mothers who neither breastfed nor took an SSRI. All but 7 of the 27 mothers took paroxetine during some part of pregnancy. Weight at 3 months was less in the paroxetine group, but multivariate analysis indicated that maternal paroxetine use was not the determining factor. Weights at 6 and 12 months were not different from the control groups and other dev

Effects on milk supply

Paroxetine can cause galactorrhea, usually with increased prolactin levels, in nonpregnant, nonnursing patients.[ 35 - 44 ] In a study of cases of hyperprolactinemia and its symptoms (e.g., gynecomastia) reported to a French pharmacovigilance center, paroxetine was found to have a 3.1-fold increased risk of causing hyperprolactinemia compared to other drugs.[ 45 ] The prolactin level in a mother with established lactation may not affect her ability to breastfeed. In a small prospective study, 8 primiparous women who were taking a serotonin reuptake inhibitor (SRI; 3 taking fluoxetine and 1 each taking citalopram, duloxetine, escitalopram, paroxetine or sertraline) were compared to 423 mothers who were not taking an SRI. Mothers taking an SRI had an onset of milk secretory activation (lactogenesis II) that was delayed by an average of 16.7 hours compared to controls (85.8 hours postpartum in the SRI-treated mothers and 69.1 h in the untreated mothers), which doubled the risk of delayed feeding behavior in the untreated group. However, the delay in lactogenesis II may not be clinically important, since there was no statistically significant difference between the groups in the percentage of mothers experiencing feeding difficulties after day 4 postpartum.[ 46 ] A case control study compared the rate of predominant breastfeeding at 2 weeks postpartum in mothers who took an SSRI antidepressant throughout pregnancy and at delivery (n = 167) or an SSRI during pregnancy only (n = 117) to a control group of mothers who took no antidepressants (n = 182). Among the two groups who had taken an SSRI, 33 took citalopram, 18 took escitalopram, 63 took fluoxetine, 2 took fluvoxamine, 78 took paroxetine, and 87 took sertraline. Among the women who took an SSRI, the breastfeeding rate at 2 weeks postpartum was 27% to 33% lower than mother who did not take antidepressants, with no statistical difference in breastfeeding rates between the SSRI-exposed groups.[ 47 ] An observational st

Levels in milk

Maternal Levels. In a pooled analysis of serum levels from published studies and 3 unpublished cases, the authors found 50 mothers taking an average daily dosage of 21 mg (range 10 to 50 mg) had an average milk paroxetine level of 28 mcg/L (range 0 to 153 mcg/L).[ 1 ] Using the average dosage and milk level data from this paper, an exclusively breastfed infant would receive an estimated 1.2% of the maternal weight-adjusted dosage of paroxetine. From data in 6 mothers taking paroxetine in an average daily dosage of 20 mg (range 10 to 30 mg), the authors estimated that an exclusively breastfed infant would receive 1.4% of the maternal weight-adjusted dosage.[ 9 ] At 2 months postpartum, 19 mothers taking an average of 25 mg of paroxetine daily had average milk levels of 13.5 mcg/L at random times after the previous dose. The authors estimated that an exclusively breastfed infant would receive 0.02 mg/kg of paroxetine daily.[ 10 ] A woman had taken paroxetine 15 mg daily during pregnancy. She did not receive a dose in the 22.75 hours before delivery or on the day of delivery. She resumed paroxetine 15 mg daily 24 hours postpartum. At 3.75 hours after the third postpartum dose, her breastmilk paroxetine level was 371 mcg/L.[ 11 ] Four nursing mothers who were 6.5 to 18.5 weeks postpartum were taking paroxetine in doses of 12.5 to 60 mg daily in addition to quetiapine for major depression postpartum. Breastmilk samples that were obtained at various times after the dose had undetectable ( 9.9 mcg/L) levels of paroxetine in 3 mothers. One mother who was taking 50 mg daily had a milk paroxetine level of 255 mcg/L.[ 12 ] A woman taking paroxetine 20 mg daily had a breastmilk paroxetine concentration below the lower limit of quantification ( 20 mcg/L) at a time that was not stated.[ 13 ] A nursing mother was taking paroxetine 20 mg daily. Foremilk and hindmilk samples taken at 4 weeks postpartum, 7 hours after a dose contained 16 mcg/L and 24 mcg/L, respectively.[ 14 ] Five w

Alternatives LactMed lists

• Nortriptyline
• Sertraline