Is UNII-3A64E3G5ZO Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use UNII-3A64E3G5ZO? Is UNII-3A64E3G5ZO safe for nursing mother and child? Does UNII-3A64E3G5ZO extracts into breast milk? Does UNII-3A64E3G5ZO has any long term or short term side effects on infants? Can UNII-3A64E3G5ZO influence milk supply or can UNII-3A64E3G5ZO decrease milk supply in lactating mothers?

• DrLact safety Score for UNII-3A64E3G5ZO is 5 out of 8 which is considered Unsafe as per our analyses.
• A safety Score of 5 indicates that usage of UNII-3A64E3G5ZO may cause serious side effects in breastfed baby.
• Our study of different scientific research indicates that UNII-3A64E3G5ZO 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-3A64E3G5ZO .
• It is recommended to evaluate the advantage of not breastfeeding while using UNII-3A64E3G5ZO Vs not using UNII-3A64E3G5ZO And continue breastfeeding.
• While using UNII-3A64E3G5ZO 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.

An ergot derivative alkaloid which is a prolactin inhibitor with dopaminergic activity, indicated for the treatment of prolactinomas and Parkinson's disease.Inhibits milk production by lowering prolactin level (Eglash 2014). Severe and frequent side effects, that are even increased in the postpartum, are: hypertension, seizures, stroke, myocardial infarction and psychiatric disorders (Hopp 1996, Iffy 1996, Kirsch 2001, Bernard 2015, Seeman 2015, Fedrizzi 2015, Snellen 2016) and thereof the indication to suppress lactation has been questioned by medical societies (Oladapo 2009-2012 Marcellin 2015, Sénat 2016) withdrawn in many countries (Nguyen 2015), switching to cabergoline has been proposed (Eglash 2014) along with non-pharmacological measures (Wong 1985 , Prescrire Int. 2013) Pharmacokinetic data (moderately high molecular weight and high binding capacity to plasma proteins) explain the observed almost zero excretion into breastmilk (Peters 1985) or below detection limits (<0.2 micrograms / L).In addition, a low oral bioavailability makes insignificant its absorption from breastmilk to the infant’s plasma. A successful breastfeeding has been described on about 30 cases of galactorrhea-prolactinoma-hyperprolactinemia that were treated with a daily dose of 2.5 to 5 mg of UNII-3A64E3G5ZO with no effects noticed on the infants (Canales 1981, Cheng 1996, Verma 2006). Nor side effects occurred on 14 infants whose mothers received 2.5 mg of UNII-3A64E3G5ZO from 5th to 8th day after birth to treat an alleged galactorrhea (Peters 1985). The risk on breastfeeding would be due to its ability for suppression of milk production, but not to a possible effect on the infant which is considered very unlikely. If UNII-3A64E3G5ZO was eventually administered to suppress lactation but afterwards the mother is willing to resuming breastfeeding, the mother can do it immediately, trying to minimize the drug effect by frequent suckling the child to stimulate milk production.

UNII-3A64E3G5ZO is usually not used during breastfeeding because it suppresses lactation. The indication of lactation suppression has been withdrawn in the U.S. and discouraged in other countries because it increases the risk of maternal stroke, seizures, cardiovascular disorders, death and possibly psychosis.[1][2][3][4] A low dose of 2.5 mg once daily has been used for 3 days to decrease overproduction of milk. The drug was undetectable in milk with this dosage and infants had no adverse reactions, but the safety of this use is not established. Case reports and series also exist of mothers treated with UNII-3A64E3G5ZO for amenorrhea-galactorrhea syndrome or prolactinoma during pregnancy and lactation who successfully breastfed their infants. UNII-3A64E3G5ZO has been used to treat persistent galactorrhea following breast augmentation surgery.[5]

No adverse effects were noticed in 14 breastfed infants of mothers who were given oral UNII-3A64E3G5ZO 2.5 mg once daily for 3 days beginning on day 5 postpartum to decrease overproduction of milk.[6] In a case series of 40 women with pituitary adenoma and hyperprolactinemia, 30 of the women took UNII-3A64E3G5ZO 2.5 or 5 mg daily during pregnancy. Thirty of the 40 women breastfed their infants, although it is not clear from the paper how many of the mothers continued to take UNII-3A64E3G5ZO during nursing. The authors reported that there were no abnormal findings in any of the breastfed infants. In an unstated number of infants who had their serum prolactin measured, it took 6 to 9 weeks for their elevated serum prolactin levels to return to baseline values.[7] A mother who was receiving UNII-3A64E3G5ZO (dosage not stated) for hyperprolactinemia from a pituitary macroadenoma breastfed her infant partially for 2 days and then exclusively from the third day onward (duration not sated). The infant had no observable side effects. She had regained her birthweight on day 10 and had gained weight adequately at 5 months.[8]

With doses of 2.5 mg 1 to 3 times daily (usually twice daily), there is a marked reduction in serum prolactin, no increase in serum prolactin following nipple stimulation and little or no breast engorgement. Treatment is usually given for 14 days. A meta-analysis of published studies found evidence that UNII-3A64E3G5ZO is more effective than placebo for lactation suppression during the first week postpartum, but evidence is insufficient to comment on the acceptability of such therapy.[9] Rebound lactation after cessation of therapy may be controlled with a dose of 2.5 mg once daily for 1 additional week.[10] UNII-3A64E3G5ZO also prevents puerperal fever caused by either breast engorgement or infection among women who do not nurse their newborn infants.[11] The indication of postpartum breast engorgement was removed in the United States in 1994 because of serious maternal toxicity, including stroke (some fatal), convulsions, myocardial infarction (some fatal) and severe hypertension.[12] One study found that seizure risk was decreased in the early puerperium, but increased slightly later.[13] Cerebral angiopathy, stroke and seizures continue to be reported from countries where UNII-3A64E3G5ZO is still used to suppress lactation.[14][15][16] An early double-blind study in 60 women who were less than 24 hours postpartum found UNII-3A64E3G5ZO to be as effective as diethylstilbestrol in suppressing postpartum lactation. UNII-3A64E3G5ZO was given in a dosage of 5 mg twice daily for 6 days followed by 5 mg three times daily for 3 days. Diethylstilbestrol dosage was 20 mg twice daily for 3 days, followed by 10 mg twice daily for 3 days, then 10 mg daily for 3 days.[17] Hyperprolactinemia and galactorrhea have been reported occasionally after withdrawal of long-term therapy with high doses (5 to 10 mg 3 times daily) of UNII-3A64E3G5ZO for treatment of parkinsonism.[18] In women given UNII-3A64E3G5ZO immediately postpartum, the composition of milk is altered from the milk of normal lactation. Most protein constituents (e.g., total protein, albumin, alpha-lactalbumin, lactoferrin, IgA and IgG) appear in higher concentrations than normal, similar to those of colostrum. Lactose levels are suppressed.[19] A study in 14 women who were overproducing milk on day 3 postpartum found that oral UNII-3A64E3G5ZO 2.5 mg once daily for 3 days reduced serum prolactin to subnormal levels, but rebounded to control levels by 36 hours after the last dose. In contrast, the milk yield decreased by 25% from baseline and the decrease persisted for at least 12 days afer the last dose.[6] A woman who was treated with UNII-3A64E3G5ZO 5 mg daily for the amenorrhea-galactorrhea syndrome during pregnancy continued taking the drug in the same dosage after delivery and successfully breastfed her infant.[20] In a case series of 40 women with pituitary adenoma and hyperprolactinemia, 30 of the women took UNII-3A64E3G5ZO 2.5 or 5 mg daily during pregnancy. Thirty of the 40 women were able to breastfeed successfully, although it is not clear from the paper how many of the mothers continued to take UNII-3A64E3G5ZO during nursing.[7] A mother who was receiving UNII-3A64E3G5ZO (dosage not stated) for hyperprolactinemia from a pituitary macroadenoma successfully breastfed her infant partially for 2 days and exclusively from the third day postpartum onward (total duration not stated). She received support from professionals and a relative who was nursing.[8] A mother with a prolactinoma took UNII-3A64E3G5ZO during pregnancy and postpartum. She was able to breastfeed her infant.[21]