Neonatal Hypotonia, Antidepressant Drug Adverse Reaction, Pregnancy Related
Conditions
Brief summary
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.
Interventions
DRUGAntidepressant
Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of neonatal hypotonia newborns following in utero exposure to antidepressant drugs, with a chronology compatible with the drug toxicity
Sponsors
University Hospital, Caen
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| neonatal hypotonia | Case reported in the World Health Organization (WHO) pharmacovigilance database to April 1st 2021 | Identification and extractions of cases of neonatal hypotonia newborns following in utero exposure to antidepressant drugs |
Countries
France
Outcome results
None listed