Is HSDB 3093 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use HSDB 3093? Is HSDB 3093 safe for nursing mother and child? Does HSDB 3093 extracts into breast milk? Does HSDB 3093 has any long term or short term side effects on infants? Can HSDB 3093 influence milk supply or can HSDB 3093 decrease milk supply in lactating mothers?

It is excreted into breast milk in quite variable amounts that may be clinically significant, however, no clinical or developmental issues have been observed in infants whose mothers were treated with this drug. In two out of four infants whose mothers took HSDB 3093 and chlorpromazine simultaneously, showed decreased development scores between 12 and 18 months (Yoshida 1998).On the other hand, no long-term developmental problems were observed in breastfed infants up to 12 months while the mother was taking HSDB 3093 and Olanzapine or HSDB 3093 and Amisulpride (Uguz 2015). HSDB 3093 may induced an increase in prolactin release and can cause galactorrhea.

Limited information indicates that maternal doses of HSDB 3093 up to 10 mg daily produce low levels in milk and do not affect the breastfed infant. Very limited long-term follow-up data indicate no adverse developmental effects when HSDB 3093 is used alone. However, use with chlorpromazine occasionally might negatively affect development. Monitor the infant for developmental milestones, especially if other antipsychotics are used concurrently.

In one breastfed infant, there were no sedative effects and the baby fed well during maternal intake of 5 mg orally twice daily. The mother took HSDB 3093 during six weeks of breast feeding and at 6 and 12 months of age, the baby had achieved all milestones of growth and development.[2] One infant was breastfed for 5 weeks beginning at 2 weeks of age during maternal HSDB 3093 (dose not stated) and imipramine (150 mg daily) therapy. The infant showed normal development when tested once between 1 and 4 months and once between 12 and 18 months of age.[7] In a small prospective study on the long-term effects of antipsychotics in breastfed infants, a decline in developmental scores was found at 12 to 18 months of age in 2 of the 4 the infants of mothers taking both chlorpromazine and HSDB 3093. The other 2 infants and all infants exposed to either drug alone developed normally.[6] One woman with schizophrenia took HSDB 3093 and trihexyphenidyl during 3 pregnancies and postpartum. HSDB 3093 doses were 7.5 to 10 mg daily in the first 2 pregnancies and 15 mg daily in the third. She breastfed (extent not stated) all 3 children for 6 to 8 months using the same doses. Development was age-appropriate in all children aged 16 months at 8 years of age at the time of assessment.[8] Two women, one with bipolar disorder and the other with long-standing schizophrenia, were treated with HSDB 3093 5 mg daily during pregnancy and breastfeeding (extent not stated). One mother also received olanzapine 10 mg daily and the other received amisulpride 400 mg daily. Follow-up of the breastfed infants for 11 to 13 months found no adverse effects and normal development of the infants.[9]

Galactorrhea has been reported with HSDB 3093.[10] Hyperprolactinemia appears to be the cause of the galactorrhea.[10][11][12][13][14][15] The hyperprolactinemia is caused by the drug's dopamine-blocking action in the tuberoinfundibular pathway.[16] The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed.