Is UNII-2X585M1M3T Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use UNII-2X585M1M3T? Is UNII-2X585M1M3T safe for nursing mother and child? Does UNII-2X585M1M3T extracts into breast milk? Does UNII-2X585M1M3T has any long term or short term side effects on infants? Can UNII-2X585M1M3T influence milk supply or can UNII-2X585M1M3T decrease milk supply in lactating mothers?

• DrLact safety Score for UNII-2X585M1M3T is 5 out of 8 which is considered Unsafe as per our analyses.
• A safety Score of 5 indicates that usage of UNII-2X585M1M3T may cause serious side effects in breastfed baby.
• Our study of different scientific research indicates that UNII-2X585M1M3T may cause moderate to high side effects or may affect milk supply in lactating mother.
• Our suggestion is to use safer alternate options rather than using UNII-2X585M1M3T .
• It is recommended to evaluate the advantage of not breastfeeding while using UNII-2X585M1M3T Vs not using UNII-2X585M1M3T And continue breastfeeding.
• While using UNII-2X585M1M3T Its must to monitor child for possible reactions. It is also important to understand that side effects vary largely based on age of breastfed child and time of medication in addition to 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.

Compound of cough and pain medication. The cytochrome P450-CYP2D6 enzyme catalyzes morphine. It is excreted in breast milk in small amounts, much lower than the dose used for newborns and infants. The plasma levels of infants whose mothers take them are very low, less than usual therapeutic levels and assuming an insignificant relative dose, less than 1.5% (Meny 1993, Naumburg 1988, Findlay 1981), so it was considered safe for use during breastfeeding (Bar-Oz 2003, WHO 2002, AAP 2001, Moretti 2000, Spigset 2000, Mitchell 1999, Meny 1993). However, excessive sedation in the mother or infant may occur if they are rapid metabolizers of codeine to morphine due to an excess of the gene linked to the P450-2D6 enzyme: this occurs in <1% of Chinese, Japanese and Hispanic people; 3% African Americans; 1-10% of Caucasians and 16-29% of North Africans, Ethiopians and Saudis (Halder 2015, Sachs 2013). The genetic diagnosis of this characteristic is not available in usual clinical practice (Madadi, 2011). Codeine through breast milk has been linked to the appearance of neonatal apnea (Naumburg, 1988), drowsiness (Ito, 1993), neurological depression (Madadi, 2008) and, above all, a fatal outcome: a newborn whose mother had this genetic abnormality died at 13 days; the mother was taking 60 mg of codeine twice daily, morphine levels were normal in breast milk, but very high in the child's plasma (Madadi 2007, Koren 2006). Subsequently, the causality of codeine in this case has been called into question (Bateman 2008, Ferner RE 2008, Young 2007). A link has been found between the use of codeine during pregnancy and breastfeeding and the risk of developing neuroblastoma in the infant (Cook, 2004). Because of all this, and with newborns having a limited capacity for opioid elimination (Willmann, 2009) and the existence of more effective alternatives, many authors and institutions advocate completely discouraging its use in infants and breastfeeding mothers (FDA 2017, Al-Adhami 2016, Lazaryan 2015, AEMPS 2015, Sachs 2013, EMA 2013). Other authors advocate cautious use (some even in the case of rapid metabolizers), using the lowest possible effective dose and for no more than 4 days and monitoring for signs of sedation in mother and infant (Royal Berkshire-NHS 2016, Halder 2015, Reece-Stremtan-ABM Protocol#21 2015, Chow 2015, Kelly 2013, UKMi NHS 2013, Rowe 2013, Montgomery-ABM protocol#15 2012, Amir 2011, Madadi 2009, Madadi 2007, FDA 2007). The use of non-steroidal anti-inflammatory drugs (NSAIDs) better controls pain and with fewer side effects than codeine alone or in combination with paracetamol (Palanisamy 2014, Hendrickson 2012, van den Anker 2012, Madadi 2009, Nauta 2009, Willmann 2009), and codeine is not included either in international consensus on the treatment of migraines (Bordini 2016, Worthington 2013). Follow WHO standards for childbirth attendance, reduce cesarean sections and episiotomies, and therefore the need for analgesics in the first few days.

Maternal use of codeine during breastfeeding can cause infant drowsiness, central nervous system depression and even death, with pharmacogenetics possibly playing a role.[1][2] Newborn infants seem to be particularly sensitive to the effects of even small dosages of narcotic analgesics. Once the mother's milk comes in, it is best to provide pain control with a nonnarcotic analgesic and limit maternal intake of oral codeine to 2-4 days at a low dosage with close infant monitoring, especially in the outpatient setting.[2][3][4][5] If the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately.[6] Excessive sedation in the mother often correlates with excess sedation in the breastfed infant. Following these precautions can lower the risk of neonatal sedation.[7] Numerous professional organizations and regulatory agencies recommend that other agents are preferred over codeine or to avoid codeine completely during breastfeeding;[8][9][10][11][12] however, other opioid alternatives have been studied less and may not be safer.[13]

Codeine was reported to be the possible cause of asymptomatic bradycardia 6 days following a 30 mg single maternal codeine dose in a week-old, term, exclusively breastfed infant.[21] Four probable cases of apnea associated with maternal codeine intake of 60 mg every 4 to 6 hours were reported in 4- to 6-day-old term and near-term breastfed infants. Apnea resolved 24 to 48 hours after withholding breast feeding and discontinuation of maternal codeine.[22] In a case-control study of 12 breastfed term newborns with unexplained episodes of apnea, bradycardia or cyanosis during the first week of life, maternal oral codeine use was determined to be the probable cause. A higher proportion of newborns with episodes, 83 vs 31%, had mothers using opiates, including codeine, for postpartum analgesia. The mean number of doses taken was also higher with mothers of case newborns taking a mean of 10 doses (range 4 to 22) vs. 5 doses (range 1 to 13) in the control group. There were no differences in other perinatal and demographic factors between cases and controls.[23] The authors recommended discontinuation of breastfeeding if infants of mothers taking opiate analgesics have unexplained negative cardiorespiratory symptoms. No apnea, bradycardia, or color changes occurred in 11 healthy, term, 1- to 3-day-old newborn breastfed infants exposed to codeine in milk. Their mothers had taken an average of 4 doses of oral codeine 60 mg every 4 to 6 hours prior to breastfeeding.[17] In one telephone follow-up study, 19% (5 of 26) of breastfeeding mothers taking multiple doses of codeine reported drowsiness in their infants. All infants were younger than 1 month.[24] The authors added that the elimination half-life of codeine's metabolite, morphine, is prolonged in the newborn period which may explain why the adverse reaction was reported in only infants younger than 1 month. A heroin-dependent mother was taking 625 mg of codeine daily as a replacement. Her infant (age and extent of nursing not stated) was described as cyanotic and apneic.[20] A large case-control study of 504 children with neuroblastoma found a statistically significant 2.4-fold association of the disease with maternal use of opioid agonists during pregnancy and lactation. This finding was largely attributable to a 3.4-fold association with maternal codeine use. Opioid exposure during lactation had a 3.5-fold association while codeine exposure had a 5.1-fold association. Because neuroblastoma is a sympathetic nervous system tumor arising from the progenitor cells of the sympathetic ganglia and adrenal medulla, and because codeine does cross the placenta and is transferred to milk, the authors of this study speculate that codeine's neuroendocrine effects could disrupt adrenal gland development in the fetus and neonate thus contributing to neuroblastoma.[25] A breastfed infant became increasingly sleepy and lethargic starting on day 7 of life. The infant developed gray skin and decreased milk intake on day 12 of life and died on day 13 of life. The infant's mother was taking acetaminophen with codeine prescribed for post-episiotomy pain at a codeine dose of 60 mg every 12 hours on days 1 and 2 postpartum, and 30 mg every 12 hours for 2 weeks. The mother was found to be a ultrarapid metabolizer of codeine who excreted very large amounts of morphine into her breastmilk.[18] The authors later conducted a retrospective case-control study of 72 women who had taken codeine while breastfeeding found that 24% of the mothers reported decreased alertness in their infants which improved after codeine or breastfeeding discontinuation. The affected infants were more likely to have visited an emergency room for symptoms such as lethargy, poor feeding or breathing difficulties. Mothers with affected infants took an average of 1.62 mg/kg daily or codeine compared to an average of 1.02 mg/kg daily in mothers of unaffected infants. The lowest maternal dose reported cause symptoms in the breastfed infant was 0.63 mg/kg daily. Usually the mothers of affected infants also had signs of central nervous system depression. Another woman was also an ultrarapid codeine metabolizer in addition to the first case reported. She took 120 mg of codeine daily and her infant was very drowsy and fed poorly and the mother was sedated, nauseated, dizzy, and weak during codeine use. The mother transitioned to complete formula feeding by day 7 postpartum and noted a complete reversal of her infant's symptoms although she remained symptomatic.[26] A study compared the frequency of drowsiness in breastfed infants whose mothers took acetaminophen plus codeine to infants whose mothers took acetaminophen alone. Infants exposed to codeine had a 16.7% frequency of drowsiness compared to 0.5% of those exposed to acetaminophen alone. Mothers having infants with drowsiness took about 50% higher doses of codeine than those with no drowsiness.[27] In a retrospective study, nursing mothers who were taking eit

Narcotics can increase serum prolactin.[31] However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed.