Question

I am a breastfeeding mother and i want to know if it is safe to use UNII-644VL95AO6? Is UNII-644VL95AO6 safe for nursing mother and child? Does UNII-644VL95AO6 extracts into breast milk? Does UNII-644VL95AO6 has any long term or short term side effects on infants? Can UNII-644VL95AO6 influence milk supply or can UNII-644VL95AO6 decrease milk supply in lactating mothers?

UNII-644VL95AO6 lactation summary

UNII-644VL95AO6 is safe in breastfeeding
  • DrLact safety Score for UNII-644VL95AO6 is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of UNII-644VL95AO6 is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that UNII-644VL95AO6 does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of UNII-644VL95AO6 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-644VL95AO6 usage in lactation

It is excreted in breast milk in clinically non-significant amount without problems in the short or long term in infants whose mothers were treated. Plasma levels of these infants were undetectable or very low. Cognitive development did not suffer any alteration. An infant was presented with thrombocytopenic purpura and anemia who recovered after removing valproate in the mother. However, doubts were raised on whether it was instead a post-viral reaction that led to idiopathic thrombocytopenic purpura. The administration of valproic acid does not affect prolactin levels. The American Academy of Pediatrics rates it as usual compatible with breastfeeding medication.WHO List of Essential Medicines 2002: compatible with breastfeeding.

Answer by DrLact: About UNII-644VL95AO6 usage in lactation

UNII-644VL95AO6 is converted to valproic acid in the body. Breastfeeding during valproic acid monotherapy does not appear to adversely affect infant growth or development, and breastfed infants had higher IQs and enhanced verbal abilities than nonbreastfed infants at 6 years of age in one study.[1] If UNII-644VL95AO6 is required by the mother, it is not necessarily a reason to discontinue breastfeeding. Because of the low levels of UNII-644VL95AO6 and valproic acid in breastmilk and infant serum, no definite adverse reactions to either drug during breastfeeding have been reported. Theoretically, breastfed infants are at risk for valproic acid-induced hepatotoxicity, so infants should be monitored for jaundice and other signs of liver damage during maternal therapy. A questionable case of thrombocytopenia has been reported with valproic acid, so monitor the infant for unusual bruising or bleeding. One author recommends monitoring infant serum valproate levels, platelets and liver enzymes during therapy.[2] Combination therapy with sedating anticonvulsants or psychotropics may result in infant sedation or withdrawal reactions.

UNII-644VL95AO6 Side Effects in Breastfeeding

An mother with epilepsy was taking valproic acid 2.4 g daily and primidone 250 mg 3 times daily during pregnancy and postpartum. During the second week postpartum, her breastfed infant was sedated. Breastfeeding was stopped and the drowsiness cleared.[3] The sedation was possibly caused by primidone in breastmilk although valproic acid might have contributed by increasing primidone levels. Petechiae, thrombocytopenia, anemia, and mild hematuria occurred in a 2.5-month-old breastfed infant whose mother was taking valproic acid 600 mg twice daily. The petechiae resolved 8 days after discontinuing breastfeeding. The authors believed the adverse effect to be caused by valproic acid in breastmilk.[14] However, other authors believe that these symptoms were more likely caused by idiopathic thrombocytopenic purpura following a viral infection.[17] Two breastfed infants aged 1 and 3 months whose mothers were taking valproic acid monotherapy 750 and 500 mg daily developed normally and had no abnormal laboratory values. Their plasma levels were 6% and 1.5% or their mother's serum levels, respectively.[15] Six breastfed infants whose mothers were taking valproic acid 750 or 1000 mg daily had no adverse reactions to valproic acid in breastmilk.[17] An exclusively breastfed infants whose mother was taking valproate 1.8 g, topiramate 300 mg, and levetiracetam 2 g, daily during pregnancy and lactation appeared healthy to the investigators throughout the 6- to 8-week study period.[18] In a long-term study on infants exposed to anticonvulsants during breastfeeding, no difference in average intelligence quotient at 3 years of age was found between infants who were breastfed (n = 11) and those not breastfed (n = 24) when their mothers were taking valproate.[19]
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