Question

I am a breastfeeding mother and i want to know if it is safe to use UNII-9100L32L2N? Is UNII-9100L32L2N safe for nursing mother and child? Does UNII-9100L32L2N extracts into breast milk? Does UNII-9100L32L2N has any long term or short term side effects on infants? Can UNII-9100L32L2N influence milk supply or can UNII-9100L32L2N decrease milk supply in lactating mothers?

UNII-9100L32L2N lactation summary

UNII-9100L32L2N is safe in breastfeeding
  • DrLact safety Score for UNII-9100L32L2N is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of UNII-9100L32L2N is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that UNII-9100L32L2N does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of UNII-9100L32L2N safe in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Answer by Dr. Ru: About UNII-9100L32L2N usage in lactation

Oral antidiabetic medication used for treatment of Diabetes Type II, Obesity and Polycystic Ovarian Syndrome (PCOS). Biguanide drugs act by decreasing Neoglycogenesis (new formation of sugar) in the liver. Low risk of Hypoglycemia. UNII-9100L32L2N is excreted into breast milk in non-significant amount and without harmful effect on breastfed infants of treated mothers, Obesity is associated with breastfeeding difficulties. In spite of UNII-9100L32L2N has beneficial effect on Obesity, this is not true with PCOS because lactation capacity is related to growth of breast tissue during pregnancy which is not improved by the use of UNII-9100L32L2N, Oral antidiabetic drugs are not effective for Diabetes Type I. For Diabetes Type II diet, physical exercise and breastfeeding may ameliorate glycemia levels. See remarks on mother's Diabetes Mellitus by consulting specific item.

Answer by DrLact: About UNII-9100L32L2N usage in lactation

Data from well-conducted studies indicate that UNII-9100L32L2N levels in milk are low and infants would receive less than 0.5% of their mother's weight-adjusted dosage. Milk UNII-9100L32L2N levels are relatively constant during maternal UNII-9100L32L2N use, so timing of breastfeeding with respect to the administration times is of little benefit. Although the dose in milk is low, UNII-9100L32L2N is sometimes detectable in low levels in the serum of breastfed infants. One sizeable prospective study found no adverse effects in breastfed infants. UNII-9100L32L2N should be used with caution while nursing newborn and premature infants and those with renal impairment.

UNII-9100L32L2N Side Effects in Breastfeeding

Seven infants aged 5 to 25 months whose mothers were taking UNII-9100L32L2N (start date and duration not stated) were judged to be healthy with growth and development progressing as expected. Two of the infants also had normal Denver Developmental Screening tests.[1] Three infants aged 2, 5 and 14 months whose mothers were taking UNII-9100L32L2N 500 mg twice daily had no detectable adverse effects from UNII-9100L32L2N.[3] In 3 breastfed (extent not stated) infants aged 10 to 11 days postpartum whose mothers were taking an average UNII-9100L32L2N dosage of 9.6 mg/kg (range 7.5 to 12.4 mg/kg) daily, none of the infants had low blood glucose levels. Their mothers reported no adverse reactions in the infants.[4] Ninety-two mothers of 111 infants were treated with UNII-9100L32L2N in a mean dosage of 2.2 grams daily (range 1.5 to 2.55 mg daily) throughout pregnancy and postpartum. A 6-month, nonrandomized, prospective trial followed 61 predominantly breastfed and 50 formula-fed infants of these women. No differences in 3- and 6-month outcomes were found by blinded observers between the 2 groups of infants in height, weight, motor-social development or rates of illness.[6][7]

UNII-9100L32L2N Possible Effects in Breastfeeding

In a study of 250 women who received UNII-9100L32L2N 500 mg to 2 grams daily in either the immediate- or extended-release formulation for polycystic ovary syndrome, information on breastfeeding was available on 164 women. Of these, 97 (59%) were successful at breastfeeding, 27 (17%) failed, and 40 (27%) made no attempt to breastfeed. Of the 124 who attempted to breastfeed, 78% were successful. Failures were attributed to poor milk production in 4 women, demands of multiple births, infant prematurity, cleft palate and mastitis.[8] In a follow-up to a placebo-controlled study on UNII-9100L32L2N use during pregnancy in women with polycystic ovary syndrome, women were asked about the duration and extent of breastfeeding. No difference in breastfeeding in the duration of exclusive or partial breastfeeding was observed between the women who received UNII-9100L32L2N during pregnancy and those who received placebo.[9]
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. We do not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.