Is FK949E Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use FK949E? Is FK949E safe for nursing mother and child? Does FK949E extracts into breast milk? Does FK949E has any long term or short term side effects on infants? Can FK949E influence milk supply or can FK949E decrease milk supply in lactating mothers?

It is excreted into breast milk in clinically significant amount. Clinical or development problems in infants whose mothers were treated have not been observed, whether at the short or long term.Very low plasma-levels in these infants were found. Galactorrhea may occur with or without an increased of Prolactin.

Maternal FK949E doses of up to 400 mg daily produce low levels in milk. Limited long-term follow-up of infants exposed to FK949E indicates that infants generally developed normally. Systematic reviews of second-generation antipsychotics concluded that FK949E seemed to be the first- or second-choice agent during breastfeeding.[1][2] Monitor the infant for drowsiness and developmental milestones, especially if other antipsychotics are used concurrently.

One mother took FK949E 25 mg daily orally during pregnancy and continued to take FK949E 50 mg daily orally during lactation. At 6 weeks the infant was doing well. No further follow-up was reported.[13] Another infant whose mother was taking 200 mg daily of FK949E began to exclusively breastfeed at 8 weeks of age. The infant was developing well at 4.5 months of age and no adverse effects were reported.[3] A nursing mother with postpartum psychosis was started on FK949E at 6 weeks postpartum at a dose of 25 mg daily along with unspecified benzodiazepines. The FK949E dosage was increased gradually to 200 mg daily over the next 6 weeks and up to 300 mg daily over the ensuing 4 weeks (16 weeks postpartum). She was also started on mirtazapine 15 mg daily at 8 weeks postpartum. Breastfeeding (extent not specified) was continued until 16 weeks postpartum when it was stopped because of reduced milk production. During this time the infant was excessively drowsy until the benzodiazepine dosage was deceased at the same time as the FK949E dosage was increased. The infant was followed for at least 2 months after breastfeeding ended and no effects on the infant's growth, motor or psychological development or signs of infant withdrawal were noted.[14] A nursing mother with bipolar disorder began taking 20 mg of paroxetine at 4 months postpartum and was then started on FK949E 200 mg twice daily at 6 months postpartum. She breastfed regularly (extent not stated) and no obvious adverse effects were noted in the infant.[15] A woman who was treated chronically with FK949E 400 mg and fluvoxamine 200 mg daily took the drugs throughout pregnancy and postpartum. She partially breastfed her infant (extent not stated) for 3 months from birth. No adverse events were seen and the infant developed normally.[16] Six nursing mothers took FK949E in doses of 25 to 400 mg daily in addition to an antidepressant (usually paroxetine) for major depression postpartum. Their breastfed infants' development were tested at 9 to 18 months of age with the Bayley scales. Measurements were slightly low on the mental and psychomotor development scale in one infant and on the mental development scale in another. All other scores were within normal limits. The authors concluded that the low scores of the 2 infants were probably not caused by the drugs received by the infants in breastmilk.[4] An infant was born to a mother taking FK949E 400 mg daily, fluoxetine 40 mg daily and oxycodone 20 mg 3 times daily. The infant was breastfed 6 to 7 times daily and was receiving 120 mcg of oral morphine 3 times daily for opiate withdrawal. Upon examination at 3 months of age, the infant's weight was at the 25th percentile for age, having been at the 50th percentile at birth. The authors attributed the weight loss to opiate withdrawal. The infant's Denver developmental score was equal to his chronological age.[5] One 60-week-old infant who was 50% breastfed was breastfed during maternal therapy with FK949E 75 mg daily mg daily and venlafaxine 225 mg daily. No adverse reactions were reported by the mother or in the medical records.[17] A woman with bipolar disorder who delivered twins and was taking sodium valproate in a therapeutic dosage was started on FK949E 200 mg and olanzapine 15 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 mother taking FK949E 100 mg each night for bipolar disorder breastfed 2 successive preterm infants. Both infants were reported to be developing normally at their last follow-up visits (exact times not specified).[12] A woman with bipolar disorder took FK949E 25 mg and lamotrigine 100 mg daily for the treatment of bipolar disorder during two pregnancies. After the first birth, she did not breastfeed, but she breastfed (extent not stated) the second infant. At the 2-month well baby checkup, the infant was meeting all developmental milestones.[18] A woman received a combination of 300 mg lamotrigine and 300 of FK949E daily for postpartum bipolar II postpartum depression. The authors reported no major adverse reactions in her breastfed (extent not stated). infant.[19] An author reported 1 infant who was breastfed (extent not stated) during postpartum maternal treatment for bipolar disorder. Her FK949E dosage was 200 mg daily. The mother reported no adverse effects in the infants.[20]

Unlike the phenothiazines, FK949E has a minimal effect on serum prolactin levels.[21][22][23] Galactorrhea occurred in a woman who was not breastfeeding while she was taking venlafaxine 112.5 mg daily and FK949E. Galactorrhea occurred 10 days after her FK949E dose was increased to 50 mg daily a few days after starting the drug at 12.5 mg daily. Her serum prolactin level was 27.3 mcg/L (normal 2 to 30 mcg/L) and decreased to 8.5 mcg/L 2 weeks after discontinuing the drug. Galactorrhea ceased 1 week later.[24] The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed.