Is Anafranil (free base) Safe in Breastfeeding

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

Excreted into breast milk in a clinically non-significant amount with no problems observed in breastfed infants from treated mothers. Levels found in the plasma of those infants were very low or undetectable. Because of a tiny excretion into the milk, symptoms due to deprivation syndrome would not be avoided by breastfeeding the infants whose mothers were taking this medication during pregnancy. Galactorrhea out of the breastfeeding period has been described.

Limited evidence indicates that use of Anafranil (free base) during breastfeeding is acceptable. For women who were taking Anafranil (free base) during pregnancy, the amount of drug in breastmilk may be insufficient to prevent neonatal withdrawal symptoms in breastfed infants. For use as an antidepressant, Anafranil (free base) may be less desirable than other antidepressants that have been studied more thoroughly.

Follow-up for 1 to 3 years in a group of 20 breastfed infants whose mothers were taking various tricyclic antidepressants found no adverse effects on growth and development. One of the mothers whose infant was followed up at 24 months of age was taking Anafranil (free base) 175 mg daily.[5] Two small controlled studies indicate that other tricyclic antidepressants have no adverse effect on infant development.[2][6] In one of the studies, 2 mothers were taking Anafranil (free base) 100 mg daily in one and 75 to 125 mg daily in the other.[2] 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 Anafranil (free base).[7] An infant was born to a mother who had taken Anafranil (free base) 25 mg daily during pregnancy. The infant exhibited inadaptation syndrome for the first few days of life. However, the infant was exclusively breastfed while the mother continued Anafranil (free base) at the same dose postpartum. At 33 days of life, the infant exhibited no clinical signs of Anafranil (free base) side effects.[3] In an observational case series of 10 infants whose mothers were taking Anafranil (free base) in daily dosages ranging from 37.5 to 125 mg daily throughout pregnancy, all infants exhibited withdrawal symptoms after birth. Five of the 10 infants were breastfed, but no difference in withdrawal symptoms was seen between breastfed and non-breastfed infants. In 5 of the infants, 4 of who were breastfed, the half-life was calculated to average 42 hours (range 27 to 68 hours). The half-life in the non-breastfed infant was 35 hours, which was not statistically different from the breastfed infants. The authors attribute the lack of differences in withdrawal and half-life between breastfed and non-breastfed infants to the small amount of drug that is excreted into breastmilk.[8]

Anafranil (free base) has caused increased prolactin levels and galactorrhea in nonpregnant, nonnursing patients.[9][10][11][12] 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.[13] 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.[14] None of the mothers were taking Anafranil (free base).