Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antidepressant | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| neonatal hypotonia | Identification and extractions of cases of neonatal hypotonia newborns following in utero exposure to antidepressant drugs | Case reported in the World Health Organization (WHO) pharmacovigilance database to April 1st 2021 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
all neonatal hypotonia newborns cases associated with in utero exposure to antidepressant drugs retrived in the two pharmacovigilance database
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital | Caen | Normandy | 14000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009123 | Muscle Hypotonia |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000928 | Antidepressive Agents |
| ID | Term |
|---|---|
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
Not provided
Not provided
Not provided
Not provided
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020164 | Chemical Actions and Uses |