Is Ro 11-1163 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Ro 11-1163? Is Ro 11-1163 safe for nursing mother and child? Does Ro 11-1163 extracts into breast milk? Does Ro 11-1163 has any long term or short term side effects on infants? Can Ro 11-1163 influence milk supply or can Ro 11-1163 decrease milk supply in lactating mothers?

Excreted into breast milk in a clinically non-significant amount. No clinical untoward effects on the physical and psychomotor development of the infants at both short and long-term basis. Some reports of galactorrhea have been described. Because there is less published experience with this drug than with others, an alternative known to be safer should be preferred mostly during the neonatal period or prematurity.

Ro 11-1163 is not approved for marketing in the United States by the U.S. Food and Drug Administration, but is available in other countries. Limited information indicates that maternal doses of Ro 11-1163 up to 900 mg daily produce low levels in milk. Although several breastfed infants apparently experienced no adverse effects during maternal use of Ro 11-1163, no rigorous, long-term data are available. Until more data are available, Ro 11-1163 should only be used with careful monitoring during breastfeeding, especially while nursing a newborn or preterm infant.

Nine women were being treated for postpartum depression with Ro 11-1163 in daily dosages ranging from 150 mg to 900 mg. All breastfed (extent not stated) their infants during therapy, but the duration of infant exposure to Ro 11-1163 in breastmilk was not stated. Maternal reports of infant weight gain, milestones and behavioral effects as well as clinical observation by the authors indicted no adverse effects in the breastfed infants.[2] Four women who took Ro 11-1163 in dosages of 300 mg to 1200 mg daily during pregnancy were followed up in the neonatal period and at 1 year postpartum. All women breastfed (extent not stated) their infants. One woman ceased breastfeeding at 2 months postpartum because of severe gastroesophageal reflux in the infant; two other mothers breastfed beyond 12 months. The duration of breastfeeding in the fourth infant was not sated. All infants achieved developmental milestones.[3]

Ro 11-1163 increases serum prolactin in males[4][5][6] and has caused galactorrhea in women.[7] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.