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 Antidepressant
Use in Children: Help or Hindrance
Suicide is the third leading cause of death
for those between the ages of 15-24. Further,
the number one cause of suicide in young adults
is untreated depression. In 2003, the FDA formally
approved the first antidepressant for use in
children with depression. The drug that was approved
was Prozac. Prozac is a serotonin re-uptake inhibitor
(SSRI).
Not long after another SSRI manufacturer sought
FDA approval for administration in this age group,
but their application was denied. The rationale
cited by the FDA was from initial reports from
clinical trials that the risk of suicidal thoughts
and actions of the trail group was twice that
of the placebo group. During that same time period,
the United Kingdom banned the prescription of
all SSRI’s for treatment of depression
in children. As a result, the level of concern
was raised even more in the U.S. prompting a
FDA investigation.
The FDA commissioned researchers to analyze
twenty-four clinical trials involving over 4,000
children. The children analyzed were taking antidepressants
for various psychiatric illnesses. The FDA’s
reported indicated that the group taking the
antidepressants had a four percent rate of suicidal
thoughts or behaviors compared to two percent
for the placebo group. It is important to note
that none of the children in these trials committed
suicide.
These findings were so disturbing to the FDA
that they released a public health advisory in
October of 2004. They went further and required
that manufacturers of antidepressants include
strong warnings in their product labels about
the administration of their product to children.
The labels on these antidepressants must carry
a “black box” warning. These warnings
are the strongest that the FDA can mandate – they
are printed near the top of package inserts in
bold type framed in a black border so that they
will easily stand out.
Sudden discontinuation of antidepressants can
leave children in a devasting circumstance. Not
to mention the physical side effects that are
associated with rapid discontinuation of these
medications. Such decisions need to be made under
the guidance of a practicing healthcare provider.
Please contact our office regarding more information
including a in house presentation on this topic.
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related to this matter are:
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locate, review and interpret relevant medical
records
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records for easy reference
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and clarify medical records
- Identify causation
issues
- Consult with healthcare providers
regarding causation and damages
- Assess damages
and injuries
- Construct written reports for attorney-client
privilege
- Research medical and nursing literature
for integration into case analysis
- Identify and
locate experts needed
References:
Mayo Clinic. Children and antidepressants:
Sorting through the warnings. Retrieved October 2006
from http://www.mayoclinic.cim/health/antidepressants/MH00059.
Marano, Hara Estroff. Antidepressants: The
Kid Question. Retrieved October 2006 from http://www.psychology.com/articles/index.php?term=pto-20040308-00000308.
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