CONTENTS HOME
HOME
Resources
Archive of Brown Newsletter


NEWS LETTER HEADER
Vol. 20, No. 11, November 2004
1. Editor's Commentary FDA decision on SSRIs oversimplifies suicide risk

Editor's Commentary
FDA decision on SSRIs oversimplifies suicide risk
By Gregory K. Fritz, M.D., Editor

No child and adolescent mental health issue has ever captured the nation's attention like the current controversy around the use of selective serotonin reuptake inhibitors (SSRIs) in youngsters. Congressional bills, FDA hearings, front page stories in major newspapers - even Consumer Reports is weighing in with advice for parents. A Google search reveals thousands of websites dealing with aspects of the controversy, each with their own perspective and biases. Reportedly, Michael Moore's next documentary will deal with aspects of pediatric psychopharmacology, and drug companies are running drills to teach their representatives what to do if approached by a large man in a baseball cap wielding a microphone.

As a child and adolescent psychiatrist, I find myself in the middle of the controversy whether I like it or not. My own bias is to be pretty conservative when prescribing medications to children. At Bradley Hospital, where I am medical director, many inpatients are discharged on fewer medications and lower doses than they were taking at the time of admission. To make sure we are not unduly influenced by pharmaceutical advertising, we do not allow drug representatives in the hospital to meet with physicians. Despite my pharmaceutical conservatism, I am dismayed about the decision that a "black box warning" is being applied to all SSRIs and other antidepressants for the treatment of depression in children and adolescents. Such a warning is the highest level of alert short of removing a drug from the market, and functionally it has the potential to eliminate or drastically curtail the use of antidepressants in patients under 19 years of age. I believe that, given the available data, the benefits of carefully prescribed and monitored antidepressant treatment far exceed the risk that taking one of these medications will precipitate suicide.

A recent "squeaky clean" panel of experts reviewing FDA-provided data on 4,400 children and adolescents who had participated in clinical trials of SSRI antidepressants concluded that 78 subjects had increased suicidal ideation or behavior while taking the medications. Fortunately, there were no deaths associated with the suicidality. The panel could not determine who, why or how these 2 - 3% of patients were at increased risk of suicide during treatment, but clinical experience provides several possibilities. First, all psychiatrists have had the experience of profoundly depressed patients becoming actively suicidal as they recovered and began to regain sufficient energy to take action on suicidal thoughts. Second, an unpleasant (but not dangerous) side effect of SSRIs is akathesia, the sense the one can't keep still. Perhaps the emergence of this side effect early in treatment, combined with ongoing depression, made some children suicidal. The medications can also precipitate mania in depressed patients who have unrecognized bipolar disorder, which in turn could lead to self-destructive behavior. Finally, the low side effect profile of SSRIs compared to earlier antidepressants has been extensively marketed to all physicians.

Primary care physicians (who prescribe up to 80% of psychoactive medications) have little training and less time than psychiatrists to adequately diagnose and closely monitor patients whom they treat with antidepressants. Inadequate follow-up could lead to the worsening of unrecognized problems, including suicidality.

Balanced against these risks are the very real dangers of untreated depression in children and adolescents. Over 500,000 adolescents attempt suicide each year, and depression is most often the cause. Impaired learning, emotional misery and parental agony are all a part of depression when it occurs in youngsters. While certainly treatable, depression is a serious problem and optimal treatment includes both psychosocial and biological interventions. An intriguing pattern reported in 2003 showed that suicide in 10 - 19 year olds decreased in regions of the country where SSRI prescriptions increased in recent years. These large scale epidemiologic data only point to associations and cannot explain causation or mechanisms. However, one would still expect the opposite pattern if the medications caused significant suicidal behavior.

The most salient issue, as yet unanswered to my satisfaction, is how well do the SSRIs work in the treatment of depression in children and adolescents? Clearly, efficacy data from adults cannot blithely be extrapolated to children (a realization that may be one of the most important outcomes of this controversy). Existing research seems to offer some support for SSRI's efficacy, but the pharmaceutical industry's practice of sponsoring research but burying unfavorable results appropriately engenders skepticism. It is my hope that all the media glare will lead to: 1) the funding of more, independent research on antidepressants (and other psychoactive drugs used in children); 2) comprehensive reporting of research results and open access to all data; 3) a reduction in casual prescribing of SSRIs and more careful monitoring of treatment; and 4) an increase in the number of child and adolescent psychiatrists so that lack of access does not result in inferior care for complicated patients. These changes will constitute a big net gain for children with psychiatric illness.



The Brown University Child and Adolescent Behavior Letter, November 2004
Reproduced with permission of Manisses Communications Group, Inc
For subscription information contact Manisses at:
208 Governor St Providence, RI02906 USA
Phone 1-401-861-6020
Fax 1-401-861-6370
E-mail: manissescs@manisses.com.



Source: The Brown University Child and Adolescent Behavior Letter
Copyright (c) 2004, Child Research Net, All Rights Reserved.