1. Suicide Risk and Antidepressants

2. Background 1990 Case reports 2003 Advisory: pediatric patients 2004 Warning: children and adolescents 2005 Advisory: suicidality in adults 2007 Current black box warning

3. 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)

4. 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)

5. 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.

6. Defining Suicidality Suicidal ideation Preparatory act Nonfatal selfharm or attempt Death

7. 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.

8. 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.

9. What Should We Do? MonitorInform

10. Age Specific Effect Children and Adolescents Young Adults: 18-2525-64 YO65 or older 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.

11. 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.

12. 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.

13. 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