Is Zypadhera Safe in Breastfeeding

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

It is excreted in breast milk in clinically non-significant amount without problems observed in infants whose mothers were receiving this treatment, whether on psychomotor development, speech improvement and weight gaining.Drug plasma levels in these infants were undetectable or very low. In the neonatal period, isolated cases of sedation and / or withdrawal symptoms have been reported, possibly by accumulative mechanism during pregnancy or added effect from another drug. Some experts think that Zypadhera would be the one of choice during lactation among second-generation antipsychotic drugs (Uguz 2016). May induce increased plasma levels of Prolactin but less frequently and lower than other antipsychotic drugs.

Maternal doses of Zypadhera up to 20 mg daily produce low levels in milk and undetectable levels in the serum of breastfed infants. In most cases, short-term side effects have not been reported, but sedation has occurred. Limited long-term follow-up of infants exposed to Zypadhera indicates that infants generally developed normally. Systematic reviews of second-generation antipsychotics concluded that Zypadhera seemed to be a first-line agent during breastfeeding.[1][2] Monitor the infant for drowsiness and developmental milestones, especially if other antipsychotics are used concurrently.

The manufacturer compiled reports of adverse effects reported in breastfed infants whose mothers were taking Zypadhera.[13] Reports were compiled from spontaneous reports from physicians and mothers, clinical trials and published papers. Details of the exposures were not provided. Some of the infants reported appear to be the same as those reported in references [4][5][6][7][13] below. Overall, 102 breastfed infants were identified whose mothers were taking Zypadhera. Of these, 62 reported dosage taken during pregnancy that averaged 7.4 mg daily by mouth. The duration of exposure to Zypadhera was reported in 30 nursing mothers with a median of 30 days and mean of 74 days. Of the infants exposed to Zypadhera via breastmilk, 15.6% reportedly experienced adverse effects, primarily somnolence, irritability, tremor and insomnia.[13] It appears that at least some of the adverse effects may have been a result of prenatal exposure to Zypadhera. One infant was breastfed for 2 months during maternal intake of Zypadhera 10 mg daily. No abnormalities were found in growth and development during 11 months of follow-up.[12] Five infants aged 3 weeks to 6 months were breastfed during maternal Zypadhera 2.5 to 10 mg daily. No adverse health or developmental effects were noted during the observation period of 5 days to 8 weeks.[4] One infant was breastfed from birth during maternal use of Zypadhera 5 mg daily orally. The infant was healthy at 6 months of age.[14] Six breastfed infants with an average age 2.4 months (range 0.1 to 4.3 months) whose mothers were taking Zypadhera 2.5 to 20 mg daily had no adverse effects reported by their mothers or found on detailed medical testing. Development was deemed normal in 4 infants after extensive testing. A fifth had a somewhat decreased intellectual development on testing, but her mother had also taken clonazepam, droperidol, sertraline, thioridazine and valproic acid while breastfeeding. Four of the infants' body weight were maintained, one fell slightly and one dropped from the 97th percentile at birth to the 50th percentile upon later measurement. One of the infants reportedly had drowsiness during maternal intake of 10 mg daily, but it was not evident 3 weeks after reducing the dose to 5 mg daily. The drowsiness was possibly related to Zypadhera in milk.[5] A 5-month-old infant was breastfed (extent not stated) by a mother who took Zypadhera 5 mg 3 times daily for 13 days, then 5 mg twice daily. The infant was followed up after 2 months. The infant gained weight steadily and no jaundice or motor function impairment were noted.[6] A case-control study compared mothers who took Zypadhera 2.5 to 10 mg daily during breastfeeding to those who took the drug and did not breastfeed, and nursing mothers who took acetaminophen which is thought to be safe during breastfeeding. Mothers filled out a questionnaire regarding adverse infant outcomes at 1 to 2 years postpartum. The percentage of adverse outcomes in the breastfed infants who were exposed to Zypadhera in breastmilk (n = 22) was greater (14%), than those in the nonbreastfed (n = 15; 7%) and breastfed infants without Zypadhera exposure (n = 51; 8%), but these differences were not statistically significant. Long-term adverse outcomes seen included speech delay in 1 infant, motor development delay in 1 infant and failure to gain weight in 2 infants (one infant experienced 2 adverse outcomes).[15] A woman took 10 mg of Zypadhera (0.18 mg/kg) daily during pregnancy and postpartum She began breastfeeding at 7 days postpartum and continued to breastfeed for an unstated period. At 12 weeks of age, a pediatric examination was normal. Another woman who took Zypadhera throughout pregnancy was taking Zypadhera 0.17 mg/kg daily while she partially breastfed her infant. The total duration of breastfeeding was not stated, but the infant had developed normally at 20 months of age.[9] A woman with bipolar disorder who delivered twins and was taking sodium valproate in a therapeutic dosage was started on Zypadhera 15 mg and quetiapine 200 mg at 11 pm daily after 20 days postpartum. She withheld breastfeeding during the night and discarded milk pumped at 7 am. She then breastfed her infants until 11 pm. The mother continued feeding the infants on this schedule for 15 months. Monthly follow-up of the infants indicated normal growth and neither the pediatricians nor the parents noted any adverse effects in the infants.[10] A woman with bipolar disorder was treated with Zypadhera 10 mg and haloperidol 5 mg daily at the end of pregnancy and during breastfeeding (extent not stated). Follow-up of the breastfed infant for 11 months found no adverse effects and normal development of the infant.[16] A woman with bipolar disorder was treated with Zypadhera 10 mg and haloperidol 5 mg daily at the end of pregnancy and during breastfeeding (extent not stated). Follow-up of the breastfed infant for 11 months found no adverse effects a

Unlike the phenothiazines, Zypadhera has a minimal effect on serum prolactin levels.[18][19][20][21][22] However, Zypadhera-induced hyperprolactinemia and galactorrhea have been reported rarely. One patient was also taking venlafaxine and interferon beta-1b which can increase serum prolactin; however, galactorrhea began only after Zypadhera was started.[23] In 2 studies, some patients who were taking a conventional antipsychotic agent or risperidone had their medication changed to Zypadhera. Previously elevated prolactin levels normalized and galactorrhea diminished or stopped.[22][24] The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed.