Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant

Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant-Analysis of Two Pharmacovigilance Databases

To better characterize the neonatal hypotonia associated with in utero exposure to antidepressants, so far limited to clinical cases, we will perform an observational retrospective pharmacovigilance study, using two databases. First, disproportionality analysis in Vigibase®, the World Health Organization global database, will be perform between antidepressant drugs and neonatal hypotonia . Second, narratives from the French National Pharmacovigilance Database will be extracted.

Inclusion Criteria:

• neonatal hypotonia newborns cases associated with in utero exposure to antidepressant drugs

Exclusion Criteria:

• Reports with maternal suicide, congenital malformation and hypotonia occurring only during breastfeeding