Dr. Henry Paul, MD

Psychiatrist, Author and Educator

ANTIDEPRESSANT DRUGS – THE BLACK BOX WARNING

January 23rd, 2014

The use of antidepressants has come under great scrutiny in the past six years due to warnings that were issued by the Federal Drug Administration. A 2003 report and another started in 2005 found that antidepressants possibly lead to increased suicidal thinking and even suicidal behavior in young people. In 2007, the FDA decided to mandate the following black box warning, so called because it is printed in a black box on the medication:

WARNINGS: SUICIDALITY AND ANTIDEPRESSANT DRUGS

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. Anyone considering the use of [drug name] 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. 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.

This was put on all antidepressants although the studies had only been done for some SSRI depressants (Selective serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed antidepressants). This warning and the accompanying publicity scared parents and led to a marked decrease (up to 50 percent) of antidepressant prescription for young people, Prozac excluded (this was the only antidepressant approved for children). This happened in spite of the fact that it was stated that no one should stop their antidepressant and that there had been no suicides in the group studied.

After the black box warnings had come out, much was written about the fact that it was almost impossible to know if the depression itself caused the suicidal trends and not the medication. The study showed that possibly 4 percent of young people developed these suicidal trends (no actual suicide) compared to 2 percent amongst those who were not treated. Many psychiatrists, including me, appeared on national news shows emphasizing that if, in fact, this was a risk, it was so rare that most of us had never even seen it and that proper monitoring by the prescribing physician would be, in all probability, enough to ward off any tragedy. Despite this, the new prescribing of antidepressants dropped markedly. Tragically, the suicide rate increased in teenagers. No scientific correlation was made, but it seems that this was related to less use of the antidepressants which could have treated the depression and prevented the suicide.

As it stands now, the anxiety about antidepressants has decreased. To my knowledge, there have been no further studies leading to alarm. Prescribing has increased again, and it appears that most prescribers are more vigilant about monitoring for this side effect. If prescribed correctly, under the guidance of an experienced professional, I do not think there is a particularly significant increased risk of suicide. Further studies about particular drugs with proper control groups will clarify the situation. I would not advise any parent to withhold antidepressants based on what we know so far, but be cautious and make sure your child is being monitored for every possible side effect.

DISCLAIMER
Information contained in this blog is intended for educational purposes only. It is not intended as medical or psychiatric advice for individual conditions or treatment and does not substitute for a medical or psychiatric examination. A psychiatrist must make a determination about any treatment or prescription. Dr. Paul does not assume any responsibility or risk for the use of any information contained within this blog.