Is Duloxetine Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Duloxetine? Is Duloxetine safe for nursing mother and child? Does Duloxetine extracts into breast milk? Does Duloxetine has any long term or short term side effects on infants? Can Duloxetine influence milk supply or can Duloxetine decrease milk supply in lactating mothers?

It is a reuptake-inhibitor of Serotonin and Norepinephrine. Excreted into breast milk in clinically non-significant amount with no side-effects being observed in breastfed infants from treated mothers. Plasma level in those infants was very low or undetectable. Because there is less experience published than with other antidepressants of the same pharmacological group, it should be preferred the use of an alternative drug that is known to be safer in the neonatal period or prematurity. Galactorrhea has been observed but less frequently than with other antidepressants. Women who use antidepressant medication during pregnancy are in need of more support for breastfeeding since they are at risk for early weaning.

Little published information is available on the use of duloxetine during breastfeeding; however, the dose in milk is low and serum levels were low in two breastfed infants. An alternate drug that has been better studied may be preferred, especially while nursing a newborn or preterm infant. If duloxetine is required by the mother, it is not a reason to discontinue breastfeeding. Monitor the infant for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of psychotropic drugs. Galactorrhea has been reported in women taking duloxetine.

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.[4]

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.[5] 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.[6] 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.[7] 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.[8] 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 and bupropion was started. Two weeks after stopping duloxetine, galactorrhea improved. Six weeks after stopping duloxetine, her serum prolactin had dropped from the previous level of 37.9 mcg/L to 20.2 mcg/L.[9] Her galactorrhea was probably caused by duloxetine. A woman being treated for migraine with duloxetine 30 mg daily began to have bilateral galactorrhea during the tenth week of treatment. At that time and on repeated measurements, her serum prolactin level was within the normal range. Her galactorrhea ceased 3 days after discontinuation of duloxetine. The authors found that her galactorrhea was probably caused by duloxetine.[10] An observational study looked at outcomes of 2859 women who took an antidepressant during the 2 years prior to pregnancy. Compared to women who did not take an antidepressant during pregnancy, mothers who took an antidepressant during all 3 trimesters of pregnancy were 37% less likely to be breastfeeding upon hospital discharge. Mothers who took an antidepressant only during the third trimester were 75% less likely to be breastfeeding at discharge. Those who took an antidepressant only during the first and second trimesters did not have a reduced likelihood of breastfeeding at discharge.[11] The antidepressants used by the mothers were not specified. A retrospective cohort study of hospital electronic medical records from 2001 to 2008 compared women who had been dispensed an antidepressant during late gestation (n = 575) to those who had a psychiatric illness but did not receive an antidepressant (n = 1552) and mothers who did not have a psychiatric diagnosis (n = 30,535). Women who received an antidepressant were 37% less likely to be breastfeeding at discharge than women without a psychiatric diagnosis, but no less likely to be breastfeeding than untreated mothers with a psychiatric diagnosis.[12] None of the mothers were taking duloxetine.