Reports of suicidal ideation and suicide attempts in
pediatric patients receiving antidepressants for major
depressive disorder will be discussed at a Feb. 2, 2004 joint
meeting of FDA’s Psychopharmacologic Drugs Advisory Committee
and the Pediatric Subcommittee of the Anti-Infective Drugs
The committee will review the reports of suicidality
from clinical trials of antidepressants and consider optimal
approaches to analysis of the data and what further research
is needed to address questions on the topic.
The group was also to consider what regulatory action
may be needed for clinical use of these products in pediatric
patients. However, that discussion has been postponed to allow
for further analysis of the data. FDA said it will
schedule another meeting by summer 2004.
In August, labeling for Wyeth’s Effexor
(venalafaxine) was revised to add a precaution based on
reports of hostility and suicide-related adverse events in
pediatric clinical trials with the serotonin and
norepinephrine reuptake inhibitor.
Wyeth submitted several Effexor studies in children and
adolescents to FDA at its request. In pediatric patients
treated with major depressive disorder, 2% of Effexor XR
patients discontinued treatment due to hostility (versus
<1% on placebo), and 2% stopped treatment as a result of
suicidal ideation (versus 0% on placebo).
In children and adolescents with generalized anxiety
disorder, 1% of Effexor patients discontinued treatment due to
abnormal/changed behavior compared to zero patients on
placebo. There were no suicides during the pediatric clinical
Data from pediatric studies with Glaxo SmithKline’s
Paxil (paroxetine) have also shown
increases in suicidality. In a June "Talk Paper", FDA said
that it was reviewing reports of a possible increased risk of
suicidal thinking and suicide attempts in children and
adolescents for the treatment of MDD with Paxil.
The data came from three well-controlled pediatric major
depression studies that fulfilled the pediatric study
requirement for Paxil CR as well as IR Paxil. FDA reported
that the risk of suicidal events ‘was about three times
greater with Paxil compared to placebo.’ Further, the studies
‘failed to show that the drug was more effective than
placebo,’ FDA said.
The U.K.’s Medicines & Healthcare Products Regulatory
Agency changed paroxetine (Seroxat in the U.K.)
labeling June 10 to reflect its conclusion that 'the balance
of risks and benefits of [paroxetine] is unfavorable when used
to treat depressive illness in [children and adolescents under
the age of 18].'
Lilly’s Prozac is approved for use in
pediatric patients with major depressive and obsessive
compulsive disorders. Pfizer’s Zoloft is
indicated for pediatric patients with OCD and is "approvable"
for pediatric depression. The drugs contain general warnings
of suicide ideation associated with depression.
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