Is HSDB 7580 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use HSDB 7580? Is HSDB 7580 safe for nursing mother and child? Does HSDB 7580 extracts into breast milk? Does HSDB 7580 has any long term or short term side effects on infants? Can HSDB 7580 influence milk supply or can HSDB 7580 decrease milk supply in lactating mothers?

HSDB 7580 and its metabolite (Paliperidone) are excreted into breast milk in non-significant amount. Untoward effect has not been observed on breastfed infants of treated mothers. Serum levels were very low or undetectable in these infants. May be a cause of galactorrhea.

Limited information indicates that maternal HSDB 7580 doses of up to 6 mg daily produce low levels in milk. Because there is little published experience with HSDB 7580 during breastfeeding and little long-term follow-up data, other agents may be preferred, especially while nursing a newborn or preterm infant. Systematic reviews of second-generation antipsychotics concluded that HSDB 7580 seemed to be a second-line agent during breastfeeding because of the limited data available and higher excretion into milk relative to other agents.[1][2]

One woman took HSDB 7580 4 mg daily during breastfeeding. Her infant showed no developmental abnormalities on examinations up to 9 months of age. Another mother took HSDB 7580 6 mg daily during breastfeeding. Her infant showed no developmental abnormalities on examinations up to 12 months of age.[7] Two women taking HSDB 7580 4 mg and 1.5 mg daily breastfed their infants of 3.3 months and 6 weeks of age, respectively, were achieving normal developmental milestones and had no adverse effects reported.[4] A 1 week postpartum woman was started on HSDB 7580 2 mg daily and increased after 10 days to a dosage of 3 mg daily. She breastfed her infant 6 times daily. The infant was observed for 5 weeks of inpatient therapy and judged normal by a pediatric neurologist. No sedation or other adverse effects were observed in the infant. After 3 months of treatment with HSDB 7580, the mother and infant were judged to be well.[5] An infant had been exclusively breastfed for 3 months during maternal therapy with HSDB 7580 1 mg daily. A pediatric examination found the infant to have no neurological or physical abnormalities, and appeared to interact appropriately.[6] 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 0.75 mg of HSDB 7580 daily, flurazepam 15 mg daily, clonazepam 0.25 mg twice daily, and 1 mg of bupropion daily reported sedation in her breastfed infant.[8]

HSDB 7580 has caused elevated prolactin serum levels, gynecomastia, and galactorrhea in patients taking the drug.[9][10][11][12][13][14][15] In one case, euprolactinemic gynecomastia and galactorrhea occurred in a 19-year-old man who was also taking fluvoxamine.[16] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.