Is SR 29001 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use SR 29001? Is SR 29001 safe for nursing mother and child? Does SR 29001 extracts into breast milk? Does SR 29001 has any long term or short term side effects on infants? Can SR 29001 influence milk supply or can SR 29001 decrease milk supply in lactating mothers?

We are working on a comment for this product.

Limited data indicate that exogenous SR 29001 does not increase normal breastmilk concentrations of growth hormone and that no adverse effects are experienced by the breastfed infants of mothers who receive SR 29001. Small studies by one group of investigators found that milk output increases from 19% to 36% after a 7-day course of SR 29001. Because mothers were not given extensive breastfeeding support in these studies, the usefulness of the drug as a galactogogue in mothers given adequate breastfeeding support is not known. Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production.[1] Based on theoretical considerations, the manufacturer of Zomacton 5 mg recommends avoiding the use of the diluent, which contains benzyl alcohol, for lactating women. Instead use preservative-free normal saline as a diluent and discard any remaining drug.

Among 34 infants in 3 studies who were breastfed during maternal use of subcutaneous SR 29001 for 7 days during lactation, none were reported to have adverse reactions to the drug. Dosages were 0.05 (n = 5), 0.1 (n = 13) or 0.2 (n = 16) international units daily.[2][4][5]

In a double-blind study, normal, lactating women were given SR 29001 0.1 international units/kg daily subcutaneously for 7 days or placebo. The 8 women given SR 29001 increased their average milk output by 157 mL daily from the baseline of 835 mL daily. Placebo-treated patients experienced an increase from 855 mL daily to 955 mL daily. The difference in increase between the two groups was statistically significant. Milk content did not change with therapy.[2] Ten mothers of premature infants born at an average of 30.6 weeks gestation (range 26 to 34 weeks) were given subcutaneous SR 29001 to increase their milk supply at an average of 39.7 days postpartum. The dosage was 0.2 international units daily, up to a maximum of 16 international units daily, for 7 days. The amount of milk produced on day 8 was compared to the average amount extracted on the 2 days prior to therapy. Average milk production increased from 139 mL daily to 175 mL daily compared to a statistically nonsignificant increase from 93 mL daily to 102 mL daily in the placebo group. Many of the mothers in the placebo group, but none in the SR 29001 group, had decreases in production during the study.[5] The differences in baseline milk production between the 2 groups might have affected the response to SR 29001 and the study did not report the changes, if any, in the proportion of infant nutrition from breastmilk. The same group studied 16 lactating mothers with normal healthy infants; 5 of the women were having lactational problems. Women received either subcutaneous SR 29001 0.05, 0.1 or 0.2 international units daily for 7 days. The two low-dose groups (n = 10) had a 4.7% increase in their milk output; mothers in the high-dose group (n = 6) increased their milk output by 36% from the baseline of 297 mL daily output. Three of the mothers who received the higher dose were able to completely or nearly completely breastfeed their infants.[4] None of the above studies reported providing mothers with information on breastfeeding technique or any other type of breastfeeding support. In a study designed to determine the genetic effects of growth hormone administration, 5 nursing mothers were given SR 29001 (Nortitropin) 0.1 mg/kg by subcutaneous injection once daily at about 800 am for 3 days. No difference was found in the average suckling-induced serum prolactin levels on day 1 (baseline) and day 4. Average milk volume did not change over the 4-day study period. The study found that DNA synthesis and cell cycle genes were induced, but no changes were observed in the expression of milk synthesis genes. The authors speculated that the duration of the study might have been too short to observe induction of milk synthesis genes.[6]