Is aripiprazole (Abilify) safe to use while breastfeeding?

Aripiprazole (Abilify) and Breastfeeding Safety

Aripiprazole is generally not recommended for breastfeeding due to limited safety data, reports of poor infant weight gain, inadequate milk supply in mothers, and relative infant doses that may exceed safety thresholds.

FDA Drug Label Information

The FDA label for aripiprazole provides critical safety concerns 1:

• Aripiprazole is present in human breast milk at relative infant doses ranging between 0.7% to 8.3% of the maternal weight-adjusted dosage 1
• Reports of poor weight gain in breastfed infants exposed to aripiprazole have been documented 1
• Reports of inadequate milk supply in lactating women taking aripiprazole 1
• The label states that "the development and health benefits of breastfeeding should be considered along with the mother's clinical need for aripiprazole and any potential adverse effects on the breastfed infant" 1

Expert Consensus and Clinical Recommendations

Breastfeeding is not currently recommended for mothers taking aripiprazole according to systematic reviews of antipsychotic safety data 2:

• A comprehensive 2013 review analyzing prospective studies, case series, and case reports categorized aripiprazole as "not recommended" for breastfeeding 2
• This categorization was based on insufficient safety data and concerns about infant exposure 2

However, some sources provide more nuanced guidance:

• A 2014 review noted that aripiprazole demonstrates "no known developmental dangers" but this was based on very limited data 3
• A 2018 systematic review concluded that while definitive evidence is lacking, the decision requires careful risk-benefit assessment 4

Key Safety Concerns

Relative Infant Dose (RID) considerations:

• The upper range of RID (8.3%) approaches or may exceed the generally accepted safety threshold of 10% 1
• RID values <10% are typically considered compatible with breastfeeding, but aripiprazole's range extends beyond this in some cases 1

Clinical manifestations in exposed infants:

• Poor weight gain has been specifically reported 1
• Maternal milk supply issues may compound feeding difficulties 1

Clinical Decision Algorithm

If aripiprazole treatment is essential during breastfeeding:

1. Consider alternative antipsychotics first - Olanzapine and quetiapine are categorized as acceptable for breastfeeding with better safety profiles 2

2. If aripiprazole must be continued:

   • Use the lowest effective dose 3
   • Monitor infant weight gain closely at every visit 1
   • Assess for signs of sedation, poor feeding, or developmental concerns 1
   • Monitor maternal milk supply adequacy 1

3. Document informed consent discussing the specific risks: poor weight gain, potential inadequate milk supply, and limited long-term safety data 1

Common Pitfalls to Avoid

• Do not assume all antipsychotics have equivalent breastfeeding safety - Olanzapine and quetiapine have substantially more reassuring data 2
• Do not rely solely on M/P ratios - The RID and clinical reports of adverse effects are more clinically relevant 1
• Do not dismiss maternal milk supply concerns - This is a documented issue specific to aripiprazole that can undermine breastfeeding success 1