Is HSDB 7993 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use HSDB 7993? Is HSDB 7993 safe for nursing mother and child? Does HSDB 7993 extracts into breast milk? Does HSDB 7993 has any long term or short term side effects on infants? Can HSDB 7993 influence milk supply or can HSDB 7993 decrease milk supply in lactating mothers?

It is a reuptake-inhibitor of Serotonin and Norepinephrine, and active metabolite of Venlafaxine. It is excreted in low amount into breast milk. The amount detected in the infant's plasma is in the range of 2% - 6% respective to the amount found in the mother's plasma that is considered to be much lower than that found when the mother takes Venlafaxine. Not relevant side-effects have been found in such infants.

Modest doses of HSDB 7993 are excreted into breastmilk, but serum drug levels of breastfed infants are less than 10% of simultaneous maternal levels. Total drug exposure of breastfed infants is about half of that experienced by breastfed infants whose mothers are taking venlafaxine.[1] Breastfed infants, especially newborn or preterm infants, should be monitored for excessive sedation and adequate weight gain if this drug is used during lactation, possibly including measurement of serum levels to rule out toxicity if there is a concern. With the related drug venlafaxine, newborn infants of mothers who took the drug during pregnancy sometimes experienced poor neonatal adaptation as seen with other antidepressants such as SSRIs or SNRIs. Similar effects may occur with HSDB 7993.

Ten infants ranging in age from 0.9 to 12.7 months were breastfed (8 exclusively) during maternal use of HSDB 7993 in doses of 50 to 150 mg daily or an average of 1.2 mg/kg daily. Mothers were also taking lorazepam (n = 6), quetiapine (n = 5), lamotrigine (n = 2), levonorgestrel (n = 2), domperidone (n = 1), and temazepam (n = 1). Infants were studied after an average of 9 days of exposure (range 4 to 35 days) of HSDB 7993 exposure via breastmilk. At the time of the study, 7 of the 10 infants were at a lower growth percentile than at the time of birth. Examination by a pediatrician found that all infants were healthy and had Denver developmental scores that matched their age on the day of the study.[1]

In an outpatient study that followed 1395 patients who received long-term HSDB 7993ne therapy, 2 patients developed elevated serum prolactin levels and one developed galactorrhea.[4] 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.[5] 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.[6] None of the mothers were taking HSDB 7993.