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.
Study Type
OBSERVATIONAL
Enrollment
10,000
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
Caen University Hospital
Caen, Normandy, France
neonatal hypotonia
Identification and extractions of cases of neonatal hypotonia newborns following in utero exposure to antidepressant drugs
Time frame: Case reported in the World Health Organization (WHO) pharmacovigilance database to April 1st 2021
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