New data suggest that black box warnings of suicidality risk are associated with a decline in mental health care and an increase in suicides among young people.
Black box warnings added to antidepressant medications on increased risk for suicidality were associated with a decline in mental health treatment and an increase in suicide attempts and deaths in young people, a new analysis suggests.
In May 2007, the FDA expanded the 2005 black box warning to include young adults through age 24, and this broader warning remains in effect today. Seven studies revealed evidence that the FDA warnings were followed by abrupt reductions in antidepressant treatment and use, ranging from 20% to 50%. Most of these studies showed increasing use of antidepressants in the years before the FDA warnings, followed by abrupt and sustained reductions in use afterward.
Less than 5% of pediatric patients were monitored in accordance with FDA's recommended contact schedule recommendations after the warnings were issued. This low rate was unchanged from the rate before the warnings.
Antidepressant Antidepressant Drug Suicide Children Child Childhood Pediatrics Kids Mental Illness Mental Disorder Psychiatric Disorder Psychiatric Illness Psychotropic Psychoactive Canada Canadian U.S. Food And Drug Administration United States Food And Drug Administration Fda Mood Disorder Peer Review Psychopharmacology Psychotherapy Young Adult
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