ArticleFrontiers in psychiatry2019
The FDA "Black Box" Warning on Antidepressant Suicide Risk in Young Adults: More Harm Than Benefits?
Article in Frontiers in psychiatry, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
47 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Systematic Review and Meta-analysis: International Prevalence of Suicidal Ideation and Attempt in Youth.Journal of the American Academy of Child and Adolescent Psychiatry · 2023Pooled it
- Efficacy of interventions for suicide and self-injury in children and adolescents: a meta-analysis.Scientific reports · 2022Pooled it
- Antidepressants and Risk of Sudden Cardiac Death: A Network Meta-Analysis and Systematic Review.Medical sciences (Basel, Switzerland) · 2021Pooled it
- Antidepressants in Children and Adolescents: Meta-Review of Efficacy, Tolerability and Suicidality in Acute Treatment.Frontiers in psychiatry · 2020Pooled it
- Repetitive transcranial magnetic stimulation frequency effects on suicidal ideation in adolescents with major depressive disorder.Journal of affective disorders · 2025Trial
- The effectiveness of behavioral activation and antidepressant medication on the reduction of suicidality in patients with major depressive disorder.BMC psychiatry · 2025Trial
- The Critical Role of Pharmacists in Addressing the Pediatric Mental Health Crisis: A Pediatric Pharmacy Association Position Paper.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- Population-Based Trends in Antidepressant Dispensing Among Children and Adolescents in Manitoba, Canada.Pharmacoepidemiology and drug safety · 2026Article
- A bibliometric analysis of global research trends and emerging hotspots on suicide and depression among children and adolescents.Discover mental health · 2026Review
- Antidepressant Augmentation of Antipsychotic Treatment in Schizophrenia: A Narrative Review.Medical science monitor : international medical journal of experimental and clinical research · 2026Review
- Prescriber-recorded indications for antipsychotic use in children and adolescents in Spain, 2015-2023: a population-based, real-world study.European child & adolescent psychiatry · 2026Article
- Antidepressant use among American adults in a 50-state survey.BMJ mental health · 2026Article
- Unveiling the Complex Interplay: Sudden Emergence of First-Rank Schneiderian Symptoms Following TMS in a Patient With Severe Depression and Complex Trauma.Case reports in psychiatry · 2026Article
- Genetic variability and response to sertraline in pediatric populations: a review on pharmacogenetics, pharmacokinetics, and the risk of adverse events.Frontiers in child and adolescent psychiatry · 2026Review
- The vicious cycle of neuroinflammation and ferroptosis in depression: mechanisms and therapeutic targets.Frontiers in neuroscience · 2026Review
- Fluoxetine Use for Very Young Children with Major Depression Disorder: A Pilot Randomized Clinical Trial.Advanced biomedical research · 2026Article
- Relationship between hippocampal volume and treatment response before and after escitalopram administration in patients with depression.Translational psychiatry · 2025Article
- Article
- Impact of diclofenac risk minimization measures addressing cardiovascular risk on analgesic use in musculoskeletal disorders.British journal of clinical pharmacology · 2025Article
- Exploring the Link Between Suicidal Concern and Pharmacotherapy in Adolescents: Evidence from a Clinical Cohort.Journal of clinical medicine · 2025Article
Corrections and comments
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The decision made in the year 2004 by the U.S. Food and Drug Administration (FDA) to require a boxed warning on antidepressants regarding the risk of suicidality in young adults still represents a matter of controversy. The FDA warning was grounded on industry-sponsored trials carried one decade ago or earlier. However, within the past decade, an increasing number of reports have questioned the actual validity of the FDA warning, especially considering a decline in the prescription of the antidepressant drugs associated with an increase in the rate of suicidal events among people with severe depression. The present report provides an overview of the FDA black box warning, also documenting two Major Depressive Disorder patients whose refusal to undergo a pharmacological antidepressant treatment possibly led to an increased risk for suicidal behaviors. The concerns raised by the FDA black box warning need to be considered in real-world clinical practice, stating the associated clinical and public health implications.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.