Is HSDB 7037 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use HSDB 7037? Is HSDB 7037 safe for nursing mother and child? Does HSDB 7037 extracts into breast milk? Does HSDB 7037 has any long term or short term side effects on infants? Can HSDB 7037 influence milk supply or can HSDB 7037 decrease milk supply in lactating mothers?

Excreted in tiny amounts into breast milk. Serum levels of breastfed infants whose mothers are on HSDB 7037 are usually undetectable or very low. No harm effect has been observed on health and short or long term development of infants. Transient troubles in the early neonatal period like drug withdrawal syndrome among newborn or premature infants with high serum levels as a result of treatment with HSDB 7037 to the mother during pregnancy have been observed. HSDB 7037 causes fewer problems related to galactorrhea than other antidepressant drugs. It is probably the safest antidepressant medication while breastfeeding. Mothers who are treated with antidepressant medicaction are in need of stronger support for a higher risk of early breastfeeding failure.

Because of the low levels of HSDB 7037 in breastmilk, amounts ingested by the infant are small and is usually not detected in the serum of the infant, although the weakly active metabolite norHSDB 7037 (desmethylHSDB 7037) is often detectable in low levels in infant serum. Rarely, preterm infants with impaired metabolic activity might accumulate the drug and demonstrate symptoms similar to neonatal abstinence. Most authoritative reviewers consider HSDB 7037 a preferred antidepressants during breastfeeding.[1][2][3][4][5][6][7] Mothers taking an SSRI during pregnancy and postpartum may have more difficulty breastfeeding, although this might be a reflection of their disease state.[8] These mothers may need additional breastfeeding support. Breastfed infants exposed to an SSRI during the third trimester of pregnancy have a lower risk of poor neonatal adaptation than formula-fed infants.

Two side effects possibly related to HSDB 7037 in breastmilk have been reported to the Australian Adverse Drug Reaction Advisory Committee. Benign neonatal sleep myoclonus occurred in one 4-month-old infant[20] and agitation that spontaneously resolved was reported in another infant.[21] None of 26 infants with an average age of 16.6 weeks (range 4 to 28 weeks) whose mothers were receiving an average of 124 mg HSDB 7037 daily had any detectable acute adverse reactions to HSDB 7037 in breastmilk. All had been breastfeeding for at least 3 weeks.[9] Whole blood serotonin levels were measured in 14 mothers and their breastfed infants after 6 to 16 weeks of HSDB 7037 therapy. Maternal dosages ranged from 25 to 200 mg daily. Although maternal serotonin levels were decreased from 159 mcg/L to 19 mcg/L by HSDB 7037 therapy, infant serotonin levels averaged 227 mcg/L before and 224 mcg/L after maternal therapy. The authors concluded that these findings indicate that the amount of HSDB 7037 ingested by the infants was not sufficient to affect platelet serotonin uptake in breastfed infants. Platelets and neurons both have the same serotonin transporter, so this lack of effect was seen as indirect evidence of safety of HSDB 7037 use during breastfeeding. None of the infants experienced any adverse effects from HSDB 7037 in breastmilk, including 6 exclusively breastfed infants under 3 months of age.[22] Twenty-five mothers who took an average HSDB 7037 dosage of 82.4 mg daily breastfed their infants exclusively for 4 months and breastfed at least 50% during months 5 and 6. Their infants had 6-month weight gains that were normal according to national growth standards and the mothers reported no abnormal effects in their infants.[23] In 6 infants aged 5 to 34 weeks whose mothers were taking HSDB 7037 50 to 100 mg daily, no adverse reactions were noted clinically at the time of the study.[10] No adverse effects were seen in 7 infants who were 4 weeks old and whose mothers had been taking HSDB 7037 50 mg daily since day 4 postpartum.[18] One study of side effects of SSRI antidepressants in nursing mothers found no adverse reactions that required medical attention among 2 infants whose mother was taking HSDB 7037. No specific information on maternal HSDB 7037 dosage, extent of breastfeeding or infant age was reported.[24] A small study compared the reaction to pain in infants of depressed mothers who had taken an SSRI during pregnancy alone or during pregnancy and nursing, to a control group of unexposed infants of nondepressed mothers. Infants exposed to an SSRI either prenatally alone or prenatally and postnatally via breastmilk had blunted responses to pain compared to control infants. Four of the 30 infants were exposed to HSDB 7037. Because there was no control group of depressed, nonmedicated mothers, an effect due to maternal behavior caused by depression could not be ruled out. The authors stressed that these findings did not warrant avoiding drug treatment of depression during pregnancy or avoiding breastfeeding during SSRI treatment.[11] An uncontrolled online survey compiled data on 930 mothers who nursed their infants while taking an antidepressant. Infant drug discontinuation symptoms (e.g., irritability, low body temperature, uncontrollable crying, eating and sleeping disorders) were reported in about 10% of infants. Mothers who took antidepressants only during breastfeeding were much less likely to notice symptoms of drug discontinuation in their infants than those who took the drug in pregnancy and lactation.[25] In a telephone follow-up study, 124 mothers who took a benzodiazepine while nursing reported whether their infants had any signs of sedation. One mother who was taking HSDB 7037 50 mg daily, zopiclone 2.5 mg about every 3 days as needed, and also took alprazolam 0.25 mg on 2 occasions, reported sedation in her breastfed infant.[26] A mother was taking HSDB 7037 150 mg daily during gestation, at delivery and postpartum while exclusively breastfeeding her infant. Her preterm infant born by cesarean section at 33 weeks gestation developed hyperthermia, muscle tone regulation disorders, and high-pitched crying during the first 24 hours after birth. The symptoms worsened on the 4th day of life, but breastfeeding was continued. On day 5, the infant had serum concentrations of HSDB 7037 and its metabolite that are in the reported therapeutic range in adults. Breastfeeding was discontinued on day 9 postpartum and the infant's symptoms dissipated, serum drug levels decreased and the infant thrived over several months. The infant was later found to have genetically intermediate metabolism of two of the CYP450 enzymes involved in HSDB 7037 metabolism. The authors attributed the infant's symptoms to serotonergic overstimulation caused by persistently high HSDB 7037 levels from breastfeeding and reduced metabolism.[12] The reaction was probably caused by HSDB 7037. An infant was bei

HSDB 7037 has caused galactorrhea in nonpregnant, nonnursing patients.[34][35][36][37] However, in a study of cases of hyperprolactinemia and its symptoms (e.g., gynecomastia) reported to a French pharmacovigilance center, HSDB 7037 was not found to have an increased risk of causing hyperprolactinemia compared to other drugs.[38] The prolactin level in a mother with established lactation may not affect her ability to breastfeed. A midwife observed 6 patients who reported a decrease in milk supply after starting HSDB 7037 (dosages not reported). One of the mothers had been taking HSDB 7037 since the 6th month of pregnancy. She reported an increase in milk supply when she stopped HSDB 7037 for one week at 4 months postpartum. When she restarted HSDB 7037, her milk supply reportedly decreased. In all of the women, the milk supply increased in 2 to 3 days after increasing fluid and the frequency of nursing.[39] 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 HSDB 7037) 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 in 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.[40] A case control study compared the rate of predominant breastfeeding at 2 weeks postpartum in mothers who took an SSRI antidepressant throughout pregnancy and at delivery (n = 167) or an SSRI during pregnancy only (n = 117) to a control group of mothers who took no antidepressants (n = 182). Among the two groups who had taken an SSRI, 33 took citalopram, 18 took escitalopram, 63 took fluoxetine, 2 took fluvoxamine, 78 took paroxetine, and 87 took HSDB 7037. Among the women who took an SSRI, the breastfeeding rate at 2 weeks postpartum was 27% to 33% lower than mother who did not take antidepressants, with no statistical difference in breastfeeding rates between the SSRI-exposed groups.[41] 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.[42] 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 7037 n = 200) 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.[43]