Is Pendramine Safe in Breastfeeding

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

A chelating agent that helps remove heavy metals such as copper, lead and mercury from the body.Used to treat Wilson's disease, cystinuria, severe rheumatoid arthritis and chronic active hepatitis. It is excreted in breast milk in clinically insignificant amounts (undetectable levels: Izumi 2012) and no problems have been observed in infants whose mothers have taken it (Sternlieb 2000, Messner 1998, Gregory 1983). Oral bioavailability decreases by half in the presence of food, so its passing to the infant’s plasma via ingested breast milk would be very difficult Copper and zinc levels in breast milk of mothers treated with Pendramine, trientine or zinc are normal according to more recent studies (Izumi 2012) and lower than normal according to older ones (Bunke 1989). Cases of breast hyperplasia and hyperprolactinemia have been reported in patients treated with Pendramine (Craig 1988, Kahl 1985, Thew 1980).

Limited information indicates that Pendramine is not detectable in breastmilk. Copper and zinc levels in breastmilk are reduced in mothers receiving Pendramine.[1][2][3][4][5] Pendramine has been used with apparent safety during nursing of 3 infants. In infants who breastfeed infrequently, taking the drug right after nursing and waiting 4 to 6 hours before nursing again should minimize the amount of Pendramine in breastmilk. Copper and zinc levels in breastmilk are reduced in patients taking Pendramine. The implications for infants of this effect are not known.

One woman taking Pendramine 1500 mg daily for cysteinuria breastfed her infant for 3 months with no apparent adverse effects in her infant.[6] Another woman breastfed 2 infants after 2 pregnancies while being treated for Wilson's disease with penicilliamine 750 mg daily. One infant had prolonged icterus that was unlikely to have been related to the Pendramine.[7] A center in Turkey reported 23 infants born to mothers with Wilson's disease over a 20-year period. Twenty-one were treated with Pendramine 600 mg and zinc 100 mg daily. All of the infants were breastfed (extent and duration not specified). One premature infant died at 3 weeks of age (maternal drug not specified), but the other infant had no apparent complications over a median of 51 months (range 13 to 105 months) of follow-up.[8]

Milk concentrations of zinc and copper are reduced during therapy of Wilson's disease with Pendramine.[3][7][8][9]