A "black box" warning on the risk of suicidality in
pediatric patients should be added to antidepressant drug
labeling, a joint FDA advisory committee
concluded.
The black box warning "won't make prescribing [in
children] more difficult," Psychopharmacologic Drugs Advisory
Committee Chair Wayne Goodman, MD, University of Florida
McKnight Brain Institute, maintained. However, he added, "I
anticipate there will be alarm from parents and the
child."
"I think that it is worth that complication because it
will raise the threshold to prescribing and force an
engagement of a discussion not only about the risk but the
potential benefits and alternatives to medication," Goodman
said.
The committee members and consultants voted 15 to eight
in favor of a black box warning.
Voting consultant Matthew Rudorfer, MD, National
Institute of Mental Health, opposed the black box. "I believe
that while we're concerned about a 2%-3% increase of risk of
suicidality, I think the underlying illness carries a 15% risk
of suicide if left untreated and I fear that the black box
will impede access to treatments," he said.
"I think the appropriate warnings could be conveyed in
bolded language that would more likely both be appreciated by
prescribers without scaring off patients and families and
clinicians," Rudorfer added.
FDA's psychopharm committee and new Pediatric Advisory
Committee met for two days to review re-analyzed and
re-classified data initially presented at a February meeting
held by FDA.
Direct-to-consumer advertising for antidepressants will
likely be affected if FDA follows the committee recommendation
to add a black box warning.
"An incidental consequence of that is that products
that carry box warnings also have to carry that in their
advertising and quite frequently that makes it quite difficult
to explicitly advertise that product in direct-to-consumer
advertising," Office of Drug Safety Deputy Director Anne
Trontell, MD/MPH, said.
"You can't use reminder ads either," Office of Drug
Evaluation I Director Robert Temple, MD,
added.
The box warning should include information on suicidal
behavior risk as well as note lack of efficacy seen in
antidepressants not approved for any use in the pediatric
population, committee members said. Lilly's Prozac
(fluoxetine) is the only antidepressant approved for treatment
of children with major depressive disorder.
A patient medication guide was also recommended by the
committees as a way to convey information to pediatric
patients and their parents.
The committee members agreed that a contraindication
for antidepressants against use in children was unnecessary
and would withhold potentially beneficial therapy from
pediatric patients.
The committee members and consultants voted unanimously
that the suicidality signal seen in the studies reviewed could
be generalized across all of the antidepressant drugs
studied.
Any warning should be considered class labeling rather
than lead to different labeling for each antidepressant based
on the specific risk shown in the studies with the particular
drug, the committees said.
"It is premature to identify a drug that should be
exempted from this warning," Goodman said.
The committees further agreed that any warning of
suicidal behavior risk should be applied to older
antidepressants not included in the studies and any new agents
approved by FDA.
That would mean Lilly's recently approved serotonin and
norepinephrine reuptake inhibitor Cymbalta
(duloxetine) would be required to carry the same boxed
warning. Cymbalta was approved for major depressive disorder
Aug. 3 and received an indication for diabetic neuropathic
pain one month later.
To
watch an archived webcast of this meeting, click the
button below. To order videotapes & DVDs, email webcasthelp@elsevier.com
or call
800-627-8171. 
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