EudraVigilance insights: Suspected adverse drug reactions in infants through breastfeeding.

ABSTRACT:

Aims

We aimed to describe suspected adverse drug reactions (ADRs) in infants resulting from medications transmitted through mothers' milk, as reported to the European ADR database, EudraVigilance. The research sought to understand the frequency, seriousness and nature of these ADRs to assess potential risks associated with maternal medication use during breastfeeding.

Methods

Data from EudraVigilance were analysed. The study included all reported ADRs suspected to be related to medications transmitted through mothers' milk from 1 January 2013 to 1 July 2023. The data were categorized by reporting time, infant age and sex, seriousness and type of ADR, and the medications involved.

Results

A total of 922 suspected ADRs were reported in breastfed infants. Serious ADRs ac

SUBMITTER: Heerfordt IM 

PROVIDER: S-EPMC12304791 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature