Antidepressants do more good than harm when it comes to
treatment of pediatric depression and anxiety disorders, according to a study
by researchers from the Center fro Innovation in Pediatric Practice (CIPP) at
Columbus Children's Hospital.
The study published in the April 18, 2007 issue of the
Journal of the American Medical Association (JAMA) found that the overall
benefits of antidepressants outweighed the risks of suicidal attempts in
children aged 19 or younger when they were treated with the medications for
pediatric major depressive disorder or MDD, obsessive-compulsive disorder or
OCD and non-OCD anxiety disorders or ANX.
Suicidal attempts associated with pediatric use of
antidepressants are a serious concern to the Food and Drug Administration.
The agency's Psychopharmacologic Drugs and
Pediatric Advisory Committees made recommendations in 2004 that the FDA require
black-box warning for an increased risk of suicidality (suicidal thoughts and
actions) associated with the use of certain antidepressants in pediatric
patients.
"Although our findings regarding suicidal thoughts and
attempts are in the same direction as the Food and Drug Administration (FDA)
meta-analysis, we found a much lower overall risk and we added analyses of the
potential benefit of these medications," said lead author Jeff Bridge, Ph.D.,
CIPP principal investigator and assistant professor of pediatrics at The Ohio
State University College of Medicine.
"This is good news for parents because it gives them
more information for discussions with their family's physician about their
child's treatment options."
What the new study found is that the risk of
antidepressants-associated suicidal attempts is lower than previously
estimated.
Specifically, the researchers
found that 1 out of 100 pediatric patients who were treated with
antidepressants for MDD, OCD and ANX would have thought of suicide or attempt
suicide beyond the risk associated with the condition itself.
This is compared to 2 out of 100 children and adolescents
younger than 19 years who were treated with antidepressants would have thought
of suicide, according to the FDA study, which included seven fewer trials, the
authors pointed out.
"Our findings mean that antidepressants should be
considered as a first-line treatment option for pediatric depression and
anxiety disorders, with the recognition that these medications are more
effective for anxiety disorders, including OCD, and modestly effective for
MDD," said Bridge.
The study also found that fluoxetine or PROZAC was the only
antidepressant that was found effective in treating depression in children
younger than 12 years, Bridge said.
For
children aged 12 years or older, several antidepressants were effective in
treating depression.
The results were derived from a meta-analysis of
twenty-seven published and unpublished randomized controlled trial reports that
looked at both the benefits and risks of antidepressants in treating children
younger than 19 years for MDD, OCD and ANX.
"We recognize that there are other therapies, aside
from antidepressants, to treat pediatric depression and anxiety disorders
including psychotherapies," said Bridge.
"While there is a small overall increased risk of
suicidal thoughts and attempts with antidepressants, the risk-benefit ratio
appears favorable."
The FDA has not reviewed the new study and the early
recommendations regarding pediatric use of antidepressants have not been
updated.
On Sept. 16, 2004, the FDA issued a statement to disclose
what the Psychopharmacologic Drugs and Pediatric Advisory Committees reported
to the agency.
According to the
statement, the members of the advisory committees:
* endorsed FDA's
approach to classifying and analyzing the suicidal events and behaviors
observed in controlled clinical trials and expressed their view that the new
analyses increased their confidence in the results;
* concluded that
the finding of an increased risk of suicidality in pediatric patients applied
to all the drugs studied (Prozac, Zoloft, Remeron, Paxil, Effexor, Celexa
Wellbutrin, Luvox and Serzone) in controlled clinical trials;
* recommended that
any warning related to an increased risk of suicidality in pediatric patients
should be applied to all antidepressant drugs, including those that have not
been studied in controlled clinical trials in pediatric patients, since the
available data are not adequate to exclude any single medication from an
increased risk;
* reached a split
decision (15-yes, 8-no) regarding recommending a "black-box" warning
related to an increased risk for suicidality in pediatric patients for all
antidepressant drugs;
* endorsed a
patient information sheet ("Medication Guide") for this class of
drugs to be provided to the patient or their caregiver with every prescription;
* recommended that
the products not be contraindicated in this country because the Committees
thought access to these therapies was important for those who could benefit;
and
* recommended that
the results of controlled pediatric trials of depression be included in the
labeling for antidepressant drugs.
