The Food and Drug Administration
(FDA) now requires drug manufacturers
to place a “black box”
warning, the federal agency’s
most serious warning, on all
antidepressant medication labels.
The message:
There is an increased risk for
suicidal thoughts and behavior—
known together as “suicidality”
—in children and adolescents
who are being treated with
antidepressant medications.
The FDA recognizes that depression
and other psychiatric disorders
in pediatric patients can result in
serious consequences if not treated
appropriately, so it is not prohibiting
the use of all antidepressants. However,
the pooled results of 24 different
placebo-controlled trials of nine
different drugs involving more
than 4,400 patients concluded the
average risk for suicidal thinking or
behavior doubled, from 2 percent of
the patients receiving a placebo to
4 percent of those actually taking
an antidepressant.
No suicides occurred during these
trials, but the FDA urges parents and
physicians to be alert for suicidal
thinking or behavior. The risk
appears to be greatest during the
first few months of treatment, or
when there is a dosage change.
If your child is on an antidepressant
medication, be alert daily for abrupt
signs of behavioral change, such as:
- Anxiety
- Agitation
- Panic attacks
- Insomnia
- Irritability
- Hostility
- Aggressiveness
- Impulsiveness
- Restlessness characterized by fidgeting and constant motion (i.e., rocking, pacing, crossing and uncrossing legs)
- Mania or hypomania (mild mania)
- Worsening of depression
- Suicidal ideas
If you detect any of the above symptoms
or any other unusual changes,
call your child’s doctor immediately.
Close monitoring or a change in
medication may be indicated.
