Is Aripiprazole safe while breastfeeding?

Effects on the breastfed infant

A woman took aripiprazole 15 mg daily by mouth during pregnancy and postpartum. She breastfed her infant (amount not stated) and at 3 months of age, the infant was growing normally.[ 3 ] A woman took aripiprazole 10 mg daily by mouth beginning in week 9 of pregnancy and continuing postpartum. She exclusively breastfed her infant for 6 weeks, then was partially breastfed. At 4 months of age the infant was still breastfeeding and had normal psychomotor and behavioral development and had reached the expected milestones for her age.[ 5 ] A 12-day-old exclusively breastfed male infant presented with severe weight loss and hypernatremic dehydration because of inadequate milk intake and a 30% weight loss since birth. The infant's mother was being treated for bipolar disorder with lamotrigine 250 mg orally once daily, aripiprazole 15 mg orally once daily, and sertraline 100 mg orally once daily. She was also taking levothyroxine 50 mcg once daily, a prenatal multivitamin, and folic acid. On initial evaluation in the emergency department, he was pale, with marbled skin, dry mucous membranes, decreased skin turgor, and bluish feet with prolonged capillary refill. The right foot eventually became darker with blackened toes, and he developed gangrene of the right lower limb, which did not respond to medical therapy and required amputation of all five toes and surgical debridement of the metatarsals. Necrosis was attributed to arterial microthrombi caused by disseminated intravascular coagulation after severe dehydration. The authors considered the mother's medications as a possible cause of the dehydration and related problems.[ 8 ] A woman with paranoid schizophrenia had been receiving long-acting injectable aripiprazole 400 mg every 28 days for 32 months when pregnancy was confirmed. The dose was lowered to 300 mg every 28 days and after delivery she breastfed her infant (extent and duration not stated). At 3 years of age, the infant s growth and development were normal.[ 9 ]

Effects on milk supply

Unlike the phenothiazines, aripiprazole has a minimal effect on serum prolactin levels and it has been used to reverse hyperprolactinemia in nonlactating patients taking other antipsychotics.[ 11 - 22 ] Case reports of both decreased lactation in nursing mothers and cases of hyperprolactinemia and galactorrhea in patients taking aripiprazole have been reported.[ 23 - 32 ] The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed. One woman began taking aripiprazole 10 mg daily at week 20 of pregnancy. She underwent a cesarean section delivery at term, but was unable to establish lactation. The authors suggested that more data are needed to determine if aripiprazole adversely affects lactation.[ 33 ] A woman took aripiprazole 10 mg daily by mouth beginning in week 9 of pregnancy and continuing postpartum. She exclusively breastfed her infant for 6 weeks, but then began supplementation because of insufficient milk production. Her serum prolactin was 35 to 40 mcg/L, which is lower than expected for a nursing mother. The authors speculated that the aripiprazole might have been the cause of her low serum prolactin and diminished her milk supply.[ 5 ] A woman with bipolar disorder was taking lithium during pregnancy and postpartum. At 10 days postpartum, her infant's serum lithium level was 0.26 mmol/L, so lithium was discontinued. Quetiapine was begun, but discontinued because of maternal sedation. Aripiprazole 2.5 mg daily was begun and within 24 hours, the mother noted a marked decrease in milk supply. After 2 weeks of working with a lactation consultant, she continued to have lactation difficulties, and she switched back to lithium. Within 48 hours, her milk supply improved markedly.[ 34 ] A retrospective study of outpatients receiving an average aripiprazole dose of 17.3 mg daily (n = 20) or another antipsychotic (n = 141) found that those receiving such high-dose aripiprazole had an 81% chance of having hypoprolacti

Levels in milk

Maternal Levels. A woman who was 6 months postpartum was taking aripiprazole 15 mg by mouth daily. Milk levels after 11 and 12 days of therapy (times not stated) at that dose were 13 and 14 mcg/L.[ 2 ] A woman took aripiprazole 15 mg daily by mouth during pregnancy and postpartum. At 3 days postpartum, aripiprazole was not detectable in colostrum because of an unknown substance that interfered with the assay. On day 27 postpartum, 3 additional milk samples were collected 30 minutes before the dose (24 hours after the last dose), and 4 and 10 hours after the dose. The drug and its metabolite were undetectable ( 10 mcg/L) in all samples. The authors estimated that a fully breastfed infant would receive less than 0.7% of the maternal weight-adjusted dosage.[ 3 ] A woman was taking aripiprazole 18 mg daily. On day 6 postpartum, a breastmilk sample (time not reported) contained a concentration of aripiprazole of 38.7 mcg/L.[ 4 ] A woman took aripiprazole 10 mg daily by mouth beginning in week 9 of pregnancy and continuing postpartum. Mid-nursing milk samples were obtained at 8 and 10 weeks postpartum over a 24-hour period after the dose. Aripiprazole and dehydroaripiprazole were measured in the milk. On the first sampling day, mean milk concentrations were 52.6 mcg/L of aripiprazole and 8.8 mcg/L for the metabolite. On the second day, mean milk concentrations were 53.6 and 6.3 mcg/L, respectively. The authors calculated that a 5 kg infant would receive a daily dose of 47 mcg daily and the weight-adjusted dosage would be 8.3% of the maternal dosage.[ 5 ] An abstract reported that a relative infant dose of 12.7% was found in nursing mother(s) taking aripiprazole who provided 8 milk samples over 24 hours, but other details were not supplied.[ 6 ] Two patients were treated with aripiprazole 5 or 10 mg daily. Aripiprazole concentrations in milk were 9.6 and 28.6 mcg/L at unspecified milk collection times.[ 7 ] Infant Levels. A woman was taking aripiprazole 18 mg daily during

Alternatives LactMed lists

• Haloperidol
• Olanzapine
• Quetiapine
• Risperidone