Antidepressants and Risk of Suicidal Thoughts, Behaviors in Children

[Guest guest]

An analysis of data from 24 clinical trials suggests that

antidepressant medications may be linked to a modest increase in the

risk of suicidal thoughts and behaviors in children, according to an

article.

http://www.newswise.com/articles/view/518479/

Newswise — An analysis of data from 24 clinical trials suggests that

antidepressant medications may be linked to a modest increase in the

risk of suicidal thoughts and behaviors in children, according to an

article in the March issue of Archives of General Psychiatry, one of

the JAMA/Archives journals.

For decades, some physicians have suspected that patients' risk of

suicidality (suicidal thoughts and behavior) increased when

pediatric patients first began taking antidepressants, according to

background information in the article. Research indicates that there

is no such association in adults. In 2003, a report submitted to the

Food and Drug Administration (FDA) suggested a link between the

antidepressant paroxetine and suicidality in pediatric patients. The

FDA then requested pediatric data from the manufacturers of eight

other antidepressant drugs, the authors report.

Tarek A. Hammad, M.D., Ph.D., and colleagues at the FDA performed a

meta-analysis of data from 23 short-term clinical trials received in

response to the request, as well as one trial funded by the National

Institute of Mental Health (NIMH). The 24 studies included 4,582

pediatric patients taking one of nine antidepressant medications for

depression, anxiety or other psychiatric disorder.

No children committed suicide in any of the trials. Although the

NIMH-funded trial was the only individual trial to show a

significant increase in suicidality among children taking

antidepressants, the analysis of all the trials together showed a

higher risk of suicidal ideation and behavior for children taking

the drugs compared with those who were not. " When considering 100

treated patients, we might expect one to three patients to have an

increase in suicidality beyond the risk that occurs with depression

itself owing to short-term treatment with an antidepressant, " the

authors write.

The FDA now requires warnings regarding the risk of suicidality in

children on antidepressant labeling and the distribution of a

patient medication guide to patients, families and caregivers, the

authors write. " Although there remain differences of opinion in the

clinical community about the strength of this signal for

antidepressant drug–induced suicidality in pediatric patients and

the implications for clinical practice, it is important to be clear

that the FDA has not contraindicated any of the antidepressant drugs

for pediatric use, " they conclude. " The FDA recognizes that

depression and other psychiatric disorders in pediatric patients can

have significant consequences if not appropriately treated. The new

warning language recognizes this need but advises close monitoring

of patients as a way of managing the risk of suicidality. "

(Arch Gen Psychiatry. 2006;63:332-339. Available pre-embargo to the

media at http://www.jamamedia.org.)

Editorial: Suicidal Behavior Different from Suicide Attempts

The small number of suicide attempts across the trials make the

results of the meta-analysis difficult for physicians and

policymakers to use, write Ross J. Baldessarini, M.D., of McLean

Hospital, Belmont, Mass., and colleagues in an accompanying

editorial.

Measuring suicidality rather than suicides or suicide attempts may

not paint an accurate picture of the risk associated with the drugs,

they continue. " Only a small fraction of patients with suicidal

thoughts attempt suicide, few attempts prove to be fatal and risk

factors for suicide attempts (e.g., younger, female) and completions

(e.g., older, male) differ markedly, " they write. " Moreover,

suicidal ideation, but usually not suicidal behavior, has been

reduced with antidepressant drug treatment. "

" When adverse responses do occur, they are often detectable with

close clinical follow-up and psychological support, especially early

in treatment, as recommended in recent FDA clinical advisories, "

they conclude. " Moreover, they may be reversed with appropriately

modified treatment. "

(Arch Gen Psychiatry. 2006;63:127-128. Available pre-embargo to the

media at http://www.jamamedia.org.)

Editor's Note: This commentary was supported, in part, by a grant

from the Bruce J. Foundation, Boston, and the McLean

Private Donors Bipolar Disorders and Psychopharmacology Research

Fund, Boston (Dr. Baldessarini), by a University of Rome fellowship

and by National Alliance for Research on Schizophrenia and

Depression, Great Neck, N.Y. Full financial disclosures are

available in the article.