Food and Drug Administration (FDA) asks manufacturers of all
antidepressant drugs to include in their labeling a boxed warning
and expanded warning statements that alert health care providers to
an increased risk of suicidality (suicidal thinking and behavior) in
children and adolescents being treated with these agents, and
additional information about the results of pediatric studies.


Text of the "black box" warning that the Food and Drug
Administration ordered included on all antidepressants:

Antidepressants increase the risk of suicidal thinking and behavior
(suicidality) in children and adolescents with major depressive
disorder (MDD) and other psychiatric disorders. Anyone considering
the use of (drug name) or any other antidepressant in a child or
adolescent must balance this risk with the clinical need. Patients
who are started on therapy should be 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. (Drug name) is not approved for
use in pediatric patients except for patients with (approved
pediatric claim).

Pooled analyses of short-term (four to 16 weeks) placebo-controlled
trials of nine antidepressant drugs (SSRIs and others) in children
and adolescents with MDD, obsessive compulsive disorder (OCD), or
other psychiatric disorders (a total of 24 trials involving over
4,400 patients) have revealed a greater risk of adverse events
representing suicidal thinking or behavior (suicidality) during the
first few months of treatment in those receiving antidepressants.
The average risk of such events on drug was 4 percent, twice the
placebo risk of 2 percent. No suicides occurred in these trials.

http://www.fda.gov/cder/drug/antidepressants/default.htm

---------------
Paul Marshall
editor@...

http://www.tourettes-disorder.com

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