A New Safety Scoring System for the Use of Psychotropic Drugs During Lactation

Am J Ther. 2021 Jan-Feb;28(1):e118-e126. doi: 10.1097/MJT.0000000000000909.


Background: Psychotropic drugs are frequently used to treat postpartum women with psychiatric diagnoses, especially psychotic disorder, major depression, and bipolar mood episodes. Pharmacotherapy in breastfeeding mothers is a major challenge.

Study question: This article presents a new safety scoring system for the use of psychotropic drugs during lactation.

Study design: The scoring system is based on the following 6 safety parameters: reported total sample, reported maximum relative infant dose, reported sample size for relative infant dose, infant plasma drug levels, prevalence of reported any adverse effect, and reported serious adverse effects. The total score ranges from 0 to 10. Higher scores represent a higher safety profile.

Results: According to this scoring system, sertraline and paroxetine, respectively, had the highest scores representing "very good safety profile." Citalopram, olanzapine, and midazolam were assigned to "good safety profile." Among drugs evaluated in this article, trifluoperazine, aripiprazole, amisulpride, clozapine, doxepin, zaleplon, and zolpidem are not recommended owing to safety scores ≤3.

Conclusions: Most psychotropic drugs examined in this article have "moderate" or "low" safety profile.

MeSH terms

  • Antipsychotic Agents* / adverse effects
  • Aripiprazole
  • Breast Feeding*
  • Female
  • Humans
  • Infant
  • Lactation
  • Psychotropic Drugs / adverse effects


  • Antipsychotic Agents
  • Psychotropic Drugs
  • Aripiprazole