TY  - JOUR
PY  - 2019//
TI  - The FDA "black box" warning on antidepressant suicide risk in young adults: more harm than benefits?
JO  - Frontiers in psychiatry
A1  - Fornaro, Michele
A1  - Anastasia, Annalisa
A1  - Valchera, Alessandro
A1  - Carano, Alessandro
A1  - Orsolini, Laura
A1  - Vellante, Federica
A1  - Rapini, Gabriella
A1  - Olivieri, Luigi
A1  - Di Natale, Serena
A1  - Perna, Giampaolo
A1  - Martinotti, Giovanni
A1  - di Giannantonio, Massimo
A1  - De Berardis, Domenico
SP  - e294
EP  - e294
VL  - 10
IS  - 
N2  - 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.<p />  <p>Language: en</p>
LA  - en
SN  - 1664-0640
UR  - http://dx.doi.org/10.3389/fpsyt.2019.00294
ID  - ref1
ER  -