Is Damilen Safe in Breastfeeding

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

It is excreted into breastmilk in a clinically non-significant amount (Bader 1980, Brixen 1982, Pittard 1986, Breyer 1995, Yoshida 1999). Plasma levels in the infant have been found undetectable (Ericsson 1979, Bader 1980, Brixen 1982, Breyer 1995) or very low (Yoshida 1997) and no side effects being observed even at maternal doses as high as 150-175 mg / day (Brixen 1982 , Misri 1991, Yoshida 1999, Nulman 2002).However, one published case of sedation on a 15-day-old infant that occured within few days after taken just 10 mg daily of Damilen by her mother because of insomnia and anxiety (Oguz 2016). Levels were not measured in either milk or plasma of the infant and the mother. Damilen may produce galactorrhoea by prolactin stimulation.

Milk levels of Damilen and its metabolites are low. Immediate side effects have not been reported and a limited amount of follow-up has found no adverse effects on infant growth and development. Damilen use during breastfeeding would usually not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. However, rare sedation has been reported in a neonate. Other agents with fewer active metabolites may be preferred when large doses are required or while nursing a newborn or preterm infant.

At least 23 infants have been reported to have been exposed to Damilen in breastmilk with no reports of adverse reactions with maternal dosages from 75 to 175 mg daily.[3][6][9][10] Follow-up for 1 to 3 years in a group of 20 breastfed infants whose mothers were taking a tricyclic antidepressant found no adverse effects on growth and development. One of the mothers whose infant was followed up at 18 months of age was taking Damilen 150 mg daily.[9] Two small controlled studies indicate that other tricyclic antidepressants have no adverse effect on infant development.[8][11] In one of the studies, 2 mothers were taking amitriptyine 100 and 175 mg daily. One of the infants tested in the low normal range from birth and on repeat testing.[8] In another study, 25 infants whose mothers took a tricyclic antidepressant during pregnancy and lactation were tested formally between 15 to 71 months and found to have normal growth and development. Some of the mothers were taking Damilen.[10] A nursing mother was prescribed Damilen 10 mg daily for insomnia. After 3 days of the medication, her 15-day-old infant developed severe sedation and an estimated 80% decrease in breastfeeding because of the sedation. The infant was otherwise normal on examination. The drug was discontinued and symptoms decreased within 24 hours and were absent after 48 hours. Damilen was restarted at 10 mg daily. The same effects reappeared in the infant and again disappeared by 48 hours after discontinuation of the drug.[12]

Damilen has caused increased prolactin levels in nonpregnant, nonnursing patients.[13][14][15] The clinical relevance of these findings in nursing mothers is not known. The prolactin level in a mother with established lactation may not affect her ability to breastfeed. 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.[16] 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; Damilen n = 30) 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.[17]