Is HSDB 6699 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use HSDB 6699? Is HSDB 6699 safe for nursing mother and child? Does HSDB 6699 extracts into breast milk? Does HSDB 6699 has any long term or short term side effects on infants? Can HSDB 6699 influence milk supply or can HSDB 6699 decrease milk supply in lactating mothers?

It is a reuptake-inhibitor of Serotonin and Norepinephrine, and a precursor of DesHSDB 6699. Excreted into breast milk in amounts that may be clinically significant, which has been found in the plasma of breastfed infants from treated mothers. However, side-effects in those infants have not been shown. Various studies failed to show short or long-term side-effects among infants whose mothers were on HSDB 6699, both on physical or psychomotor development. It may induce galactorrhea. The poor extrauterine adaptation that may appear in neonates just after birth when the pregnant woman has been treated with selective reuptake-inhibitors of Serotonin like HSDB 6699 or Mirtazapine, is seen to be mild if the baby is breastfed. In the case report of a mother who was taking this medication during pregnancy, her infant had shown amelioration of symptoms due to Abstinence Syndrome after having been breastfed. Women who use antidepressant medication during pregnancy are in need of more support for breastfeeding since they are at risk for early weaning.

Infants receive HSDB 6699 and its active metabolite in breastmilk, and the metabolite of the drug can be found in the plasma of most breastfed infants; however, concurrent side effects have rarely been reported. 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 of desHSDB 6699 (O-desmethylHSDB 6699), to rule out toxicity if there is a concern. However, newborn infants of mothers who took the drug during pregnancy may experience poor neonatal adaptation syndrome as seen with other antidepressants such as SSRIs or SNRIs. Use of HSDB 6699 during breastfeeding has been proposed as a method of mitigating infant HSDB 6699 withdrawal symptoms,[1][2] but this has not been rigorously demonstrated.

No acute adverse effects or abnormal weight gain were seen in 3 breastfed infants who had detectable serum levels of desHSDB 6699.[4] No adverse effects on growth or in sleep, feeding or behavioral patterns were noticed clinically in 2 infants who were exclusively breastfed for 6 months during maternal therapy with HSDB 6699 75 and 150 mg daily.[12] Three mothers took an average HSDB 6699 dose of 162.5 mg once daily. They breastfed their infants exclusively for 4 months and at least 50% during months 5 and 6. Their infants had 6-month weight gains that were normal according to national growth standards.[13] Seven infants (including 1 set of twins) breastfed for 2.7 to 10.3 months during maternal HSDB 6699 therapy. Three mothers were taking HSDB 6699 since birth and 3 were started later. Denver Developmental Screening Tests in all infants were normal. All but 2 had normal growth; these 2 had a decrease in weight gain.[5] In 3 infants aged 8 to 30 weeks whose mothers were taking HSDB 6699 75 to 225 mg daily, no adverse reactions were noted clinically at the time of the study.[7] An newborn infant whose mother had been taking HSDB 6699 375 mg daily during pregnancy had symptoms of lethargy, poor sucking ability, and dehydration at 2 days of age. The infant was allowed to breastfeed and the symptoms subsided over 1 week. The authors concluded that the symptoms were likely withdrawal symptoms that were mitigated by the HSDB 6699 in breastmilk.[1] Another infant whose mother was taking HSDB 6699 300 mg daily was reported by the same center. In this case, the infant's symptoms of withdrawal improved markedly on day 7 when breastfeeding was initiated, but no drugs levels were measured in milk or in the infant.[2] Two nursing mothers were taking HSDB 6699 and quetiapine for postpartum depression; one was also taking trazodone. Their breastfed infants' development were tested at 12 to13 months of age with the Bayley Scales. Scores were within normal limits on the mental, psychomotor and behavior scales.[14] Thirteen infants whose mothers were taking HSDB 6699 in doses ranging from 37.5 to 300 mg daily were breastfed (11 exclusively and 2 about 50%). Three of the infants were also exposed to a second psychotropic drug in breastmilk: 1 each of buspirone, trazodone, quetiapine. None of the infants had any adverse reactions reported by their mothers or in their medical records.[9] Two nursing mothers who were 6.5 and 9.5 weeks postpartum were taking HSDB 6699 in doses of 75 and 225 mg daily, respectively, in addition to quetiapine for major depression postpartum; one mother was also taking trazodone. Their breastfed infants' development were tested at 9 to 18 months of age with the Bayley Scales. Both infants had scores that were within normal limits.[8] A mother was taking HSDB 6699 75 mg daily for depression and anxiety, although when the drug was started is not clear from the report. Her 1-month-old infant was seen in a pediatric clinic and was demonstrating agitation, infantile colic, drowsiness, increased startle response, jitteriness and sleeplessness. The symptoms began at 1 week of age and became progressively worse over time and with breastfeeding. The symptoms were possibly caused by HSDB 6699, although whether they represent a withdrawal reaction of direct drug effects cannot be determined.[15] A woman with depression and anxiety was treated with HSDB 6699 300 mg daily monotherapy beginning at 20 weeks of pregnancy. On day three of life, the infant had extensor posturing and cycling of the limbs which was thought to be seizure related. Clinical examination was normal. Her suck was noted to be strong but uncoordinated and the infant fatigued rapidly. The infant was partially breastfed initially, but when breastmilk feeding was discontinued, the infant''s alertness improved and she gained 314 grams over 7 days. The authors felt that HSDB 6699 in breastmilk might have contributed to the infant's lethargy, especially given the high maternal dosage. The symptoms were possibly caused by HSDB 6699 in breastmilk.[16] A woman was treated with HSDB 6699 75 mg daily during the third trimester of pregnancy and during breastfeeding. Pediatric evaluation including neurologic assessment and brain ultrasound were conducted during the first 24 hours postpartum. Further follow-up was conducted at 6 or more months of age. The infant's clinical status was comparable to unexposed infants from the same pediatric department.[10]

Cases of galactorrhea and elevated serum prolactin have been reported in which HSDB 6699 played a primary or secondary role in the etiology.[14][17][18][19][20][21][22][23] Galactorrhea with normal prolactin levels has also been reported.[24] The prolactin level in a mother with established lactation may not affect her ability to breastfeed. One mother who was nursing a 10.3-month-old infant reported that her milk letdown took longer after starting HSDB 6699 1 month earlier.[5] 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.[25] 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; HSDB 6699 n = 68) 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.[26]