suicide risk and antidepressants. background 1990 case reports 2003 advisory: pediatric patients...
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Suicide Risk and Antidepressants
Background
1990
• Case reports
2003
• Advisory: pediatric patients
2004
• Warning: children and adolescents
2005
• Advisory: suicidality in adults
2007
• Current black box warning
The Warning
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. (Continues)
The Warning
Anyone considering the use of [brand name here] or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.
(Continues)
The Warning
Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
Defining Suicidality
Suicidal ideation Preparatory act
Nonfatal selfharm or
attempt Death
More about the black box warning
9 antidepressants 24 short term placebo controlled trials
N=4587
Hammad TA, Laughren T, Racoosin J. Suicidality in pediatric patients treated with antidepressant drugs. Arch Gen Psychiatry 2006; 63:332.
More about the warning
N=4587 Antidepressant
• 4% suicidality
Placebo
• 2% suicidality
No completed suicides
Hammad TA, Laughren TP, Racoosin JA. Suicide rates in short-term randomized controlled trials of newer antidepressants. J Clin Psychopharmacol 2006; 26:203.
What Should We Do?
MonitorInform
Age Specific Effect
Children and Adolescents
Young Adults: 18-25 25-64 YO 65 or older
Small increase in suicidality
Small increase in suicidality
No detectable effect
Probably protective
Leon AC. The revised warning for antidepressants and suicidality: unveiling the black box of statistical analyses. Am J Psychiatry 2007; 164:1786.
Is there any difference between antidepressants?
No difference in risk between classes: SSRIs, SNRIs, TCAs, MAOIs and other antidepressants.
Khan A, Khan S, Kolts R, Brown WA. Suicide rates in clinical trials of SSRIs, other antidepressants, and placebo: analysis of FDA reports. Am J Psychiatry 2003; 160:790.
Effects of the Black Box Warning
• Decline in:• rates of diagnosis of pediatric depression.• treatment with SSRIs.
Libby AM, Orton HD, Valuck RJ. Persisting decline in depression treatment after FDA warnings. Arch Gen Psychiatry 2009; 66:633.
Key points
• The FDA warning alerts about increased risk of suicidality• Age specific effect: increased risk in children, adolescents and adults
18 – 25 years.• No actual suicides were completed in the studies reviewed• The FDA recommends monitoring during the first few weeks of
treatment• No difference between antidepressant classes
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