Is Spiron Safe in Breastfeeding

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

Spiron 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 Spiron doses of up to 6 mg daily produce low levels in milk. Because there is little published experience with Spiron 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 Spiron 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 Spiron 4 mg daily during breastfeeding. Her infant showed no developmental abnormalities on examinations up to 9 months of age. Another mother took Spiron 6 mg daily during breastfeeding. Her infant showed no developmental abnormalities on examinations up to 12 months of age.[7] Two women taking Spiron 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 Spiron 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 Spiron, the mother and infant were judged to be well.[5] An infant had been exclusively breastfed for 3 months during maternal therapy with Spiron 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 Spiron daily, flurazepam 15 mg daily, clonazepam 0.25 mg twice daily, and 1 mg of bupropion daily reported sedation in her breastfed infant.[8]

Spiron 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.