Is Duloxetine safe while breastfeeding?

Effects on the breastfed infant

A partially nursing mother was taking duloxetine 90 mg and extended-release methylphenidate (Concerta) 36 mg daily for ADHD, generalized anxiety disorder, borderline personality disorder, and depression. She partially (amount not stated) breastfed her infant for about 1 month. At 6 months of age, infant's development was considered to be normal, except for recurrent pneumonia caused by congenital pulmonary airway malformation. Another mother took duloxetine 60 mg daily while partially (amount not stated) nursing her infant. At 6 weeks of age, no adverse events were observed in the exposed infant.[ 6 ] One mother reported a possible adverse reaction of drowsiness in her baby in the first few weeks after birth. She was taking agomelatine in an unspecified dose with duloxetine 90 mg daily. She attributed the drowsiness to agomelatine and continued breastfeeding her baby until 9 months of age. She reported some developmental concerns of speech and low muscle tone in her baby who was 9 months of age at the time of follow-up.[ 7 ]

Effects on milk supply

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 compared to 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.[ 8 ] After one nonpregnant woman began taking duloxetine, her serum prolactin increased and previous galactorrhea, which had decreased after stopping venlafaxine, increased again. After stopping duloxetine, her prolactin decreased to normal and galactorrhea ceased.[ 9 ] A woman who was taking duloxetine at an unspecified dose for depression reported a milky discharge from her nipples. She had not experienced this effect with previous antidepressant therapy. Her serum prolactin was elevated, and an MRI of her head found no tumors. Duloxetine was stopped and she was treated with escitalopram 20 mg daily and cabergoline 0.5 mg twice weekly for one month. At this time her serum prolactin was normal and the galactorrhea had stopped.[ 10 ] In a study of cases of hyperprolactinemia and its symptoms (e.g., gynecomastia) reported to a French pharmacovigilance center, duloxetine was not found to have an increased risk of causing hyperprolactinemia compared to other drugs.[ 11 ] A woman taking duloxetine 60 mg daily for depression complained of a milky breast discharge, breast fullness, and breast pain, after taking the drug for a total of 10 weeks. Duloxetine was discontinued

Levels in milk

Maternal Levels. Six lactating women who were at least 12 weeks postpartum and weaning their infants were given duloxetine 40 mg with food every 12 hours for 3.5 days. Milk samples from both breasts were obtained before and at 1, 2, 3, 6, 9 and 12 hours after the dose on day 4. Peak milk duloxetine levels occurred at an average of 6 hours after the dose. The amount of duloxetine excreted into breastmilk was approximately 7.4 mcg (range 3.6 to 15 mcg) daily in these women. The normalized milk excretion corresponded to a daily infant dosage of 0.2 mcg/kg or 0.14% (maximum 0. 0.25%) of the weight-adjusted maternal dosage. The excretion of duloxetine metabolites, which are inactive, into breastmilk was not studied.[ 3 ] A woman took oral extended-release duloxetine 60 mg (868 mcg/kg) daily during pregnancy and breastfeeding. On day 32 postpartum, milk samples were obtained 10 minutes and 6 hours after the dose. The first (trough) sample contained 31 mcg/L of duloxetine and the second (peak) sample contained 64 mcg/L. The authors calculated that an exclusively breastfed infant would receive a dose of 7.1 mcg/kg daily at this maternal dosage, corresponding to 0.82% of the weight-adjusted maternal dosage.[ 4 ] A woman with recurrent depression took duloxetine 60 mg daily throughout pregnancy and breastfeeding. At 18 days postpartum, the mother collected milk samples before the daily dose and at 8 more times during the next 22.5 hours. The peak milk concentration occurred at about 7 hours after the dose. The average milk concentration over the 24-hour dosage interval was 51 mcg/L. Hindmilk concentrations were somewhat higher than foremilk concentrations at the 2 times when they were measured separately. The authors estimated that the infant received a duloxetine dose of 0.81% of the mothers weight-adjusted dose via breastmilk.[ 5 ] A partially nursing mother was taking duloxetine 90 mg and extended-release methylphenidate (Concerta) 36 mg daily for ADHD, generalized anxiety

Alternatives LactMed lists

• Sertraline
• Nortriptyline
• Paroxetine