Table 3.
Pediatric Labeling Aproval Date | Pharmaceutical Substance | Indication | Therapeutic Category | Weight Gain Risk |
---|---|---|---|---|
28/1/2022 | ziprasidone | BD-I (10 to 17 years) | SGA | Low |
27/12/2021 | brexpiprazole | Schizophrenia (13 to 17 years) | SGA | Low |
5/3/2018 | lurasidone | Treatment of MDE associated with BD-I | SGA | Low |
27/1/2017 | lurasidone | Treatment of schizophrenia in adolescents and irritability associated with autistic disorder in pediatric patients | SGA | Low |
12/3/2015 | asenapine | Schizophrenia and Acute Manic or Mixed Episodes Associated with BD-I | SGA | Moderate |
31/10/2014 | escitalopram | MDD | SSRI | Moderate |
16/10/2014 | duloxetine | GAD | SNRI | Low |
26/7/2013 | olanzapine/fluoxetine | Depressive episodes associated with BD-I | SGA/ SSRI | High |
30/4/2013 | quetiapine | Bipolar depression | SGA | Moderate |
18/10/2012 | duloxetine | MDD | SNRI | Moderate |
2/12/2009 | quetiapine | Schizophrenia (13 to 17 years) and bipolar mania (10 to 17 years) | SGA | Moderate |
19/3/2009 | escitalopram | MDD in adolescents | SSRI | Moderate |
14/8/2008 | olanzapine | schizophrenia; BD | SGA | High |
27/2/2008 | aripiprazole | BD-I | SGA | Moderate |
29/10/2007 | aripiprazole | Schizophrenia | SGA | Moderate |
22/8/2007 | risperidone | Schizophrenia;short-term treatment of acute manic or mixed Episodes associated with BD-I | SGA | High |
18/2/2005 | citalopram | MDD | SSRI | Moderate |
18/2/2005 | sertraline | MDD & OCD | SSRI | Low |
12/1/2005 | paroxetine | MDD | SSRI | Low |
12/1/2005 | mirtazapine | MDD | NaSSA | High |
12/1/2005 | nefazodone | MDD | SARI | Low |
5/5/2004 | venlafaxine | MDD | SNRI | Low |
3/1/2003 | fluoxetine | MDD & OCD | SSRI | Low |
19/7/2001 | buspirone | GAD | Anti-Anxiety Agents/Anxiolytics | Low |
ABBREVIATIONS: BD-I = Bipolar Disorder I; MDE = Major Depressive Episode; MDD = Major Depressive Disorder; OCD = Obsessive Compulsive Disorder; GAD = Generalized Anxiety Disorder; SGA = Second-generation antipsychotic; SSRI = Selective serotonin reuptake inhibitor; SNRI = Serotonin and norepinephrine reuptake inhibitor; NaSSA = Noradrenergic and specific serotonergic antidepressant. NOTES: Data on medication have been drawn from the FDA (https://www.fda.gov/science-research/pediatrics/pediatric-labeling-changes). Weight gain risk was assessed based on studies on underaged populations. When these were not available, assessment was based upon adult populations.