Is NT-0201 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use NT-0201? Is NT-0201 safe for nursing mother and child? Does NT-0201 extracts into breast milk? Does NT-0201 has any long term or short term side effects on infants? Can NT-0201 influence milk supply or can NT-0201 decrease milk supply in lactating mothers?

• DrLact safety Score for NT-0201 is 5 out of 8 which is considered Unsafe as per our analyses.
• A safety Score of 5 indicates that usage of NT-0201 may cause serious side effects in breastfed baby.
• Our study of different scientific research indicates that NT-0201 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 NT-0201 .
• It is recommended to evaluate the advantage of not breastfeeding while using NT-0201 Vs not using NT-0201 And continue breastfeeding.
• While using NT-0201 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.

A sympathomimetic drug and central nervous system stimulant, it has a similar action and uses to its isomer dextroNT-0201.It is used in the treatment of narcolepsy (Wise, 2007) and Attention Deficit Hyperactivity Disorder (ADHD), and is also used as an illegal drug (Oei, 2012; Bartu, 2009). It is excreted in breast milk, concentrating between 2 and 8 times more than in plasma (FDA, 2017; Steiner, 1984). This concentration, although it could be significant (Bartu, 2009), assumes a relative dose between 2% (Öhman, 2015) and 13.8% (FDA, 2017). In infants whose mothers were taking NT-0201 as narcolepsy treatment, low plasma levels (Öhman, 2015) and urine (Steiner, 1984) were measured and no problems were observed in the clinical follow-up of these infants (Öhman, 2015; Steiner, 1984). There is little information on the impact of NT-0201 abuse on the development and health of infants (Oei, 2012, Wise, 2007; Moretti, 2000), but it is known that they are more exposed to social problems, domestic violence, and lower breastfeeding rates (Oei, 2010). To minimize the risk, it is estimated that 48 hours should pass after the last NT-0201-based recreational use, before breast-feeding (Bartu, 2009). There is controversy over the possibly mild negative effect of NT-0201 on prolactin (Petraglia, 1987; DeLeo, 1983), but milk production in mothers who took it therapeutically was not affected (Öhman, 2015). During breastfeeding, the therapeutic use (narcolepsy, ADHD) of NT-0201 can be assessed, using the lowest possible effective dose and monitoring the occurrence of irritability, insomnia, lack of appetite and weight loss. Its use as an illegal drug is totally discouraged (Oei, 2012).

In dosages prescribed for medical indications, some evidence indicates that NT-0201 does not affect nursing infants adversely. The effect of NT-0201 in milk on the neurological development of the infant has not been well studied. Large dosages of NT-0201 might interfere with milk production, especially in women whose lactation is not well established. Breastfeeding is generally discouraged in mothers who are actively abusing NT-0201s.[1][2][3] One expert recommends that NT-0201 not be used therapeutically in nursing mothers.[4]

One infant whose mother was being treated for narcolepsy with racemic NT-0201 5 mg 4 times daily was exposed to the drug in milk for the (unspecified) duration of breastfeeding. There were no signs of abnormal development during the first 2 years of life.[5] The infant of a mother who was taking NT-0201 35 mg daily for narcolepsy during pregnancy and postpartum was exclusively breastfed for 6 months. The infant experienced no adverse reactions and grew normally.[6]

In 2 papers by the same authors, 20 women with normal physiologic hyperprolactinemia were studied on days 2 or 3 postpartum. Eight received dextroNT-0201 7.5 mg intravenously, 6 received 15 mg intravenously and 6 who served as controls received intravenous saline. The 7.5 mg dose reduced serum prolactin by 25 to 32% compared to control, but the difference was not statistically significant. The 15 mg dose significantly decreased serum prolactin by 30 to 37% at times after the infusion. No assessment of milk production was presented.[7][8] The authors also quoted data from another study showing that a 20 mg oral dose of dextroNT-0201 produced a sustained suppression of serum prolactin by 40% in postpartum women. The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed. In a retrospective Australian study, mothers who used intravenous NT-0201s during pregnancy were less likely to be breastfeeding their newborn infants at discharge than mothers who abused other drugs (27% vs 42%). The cause of this difference was not determined.[9] A mother took NT-0201 35 mg daily for narcolepsy during pregnancy and postpartum. She exclusively breastfed her infant for 6 months with no evidence of an adverse effect on milk production.[6]