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U.S.
Requires New Warning on Antidepressants for Children |
Posted:10.18.04
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Antidepressant drugs can cause increased suicidal thoughts and
behaviors in children and adolescents, according to the Food and
Drug Administration (FDA), and must now contain a special warning.
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The FDA, which watches over the safety of food and medicine,
 ruled
that within the next few months, antidepressant packages must
have a "black box" warning -- the strongest government
alert.
The decision comes after years of research and after the government
in Great Britain warned doctors not to prescribe antidepressants
for teenagers.
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The FDA's
plan |
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According to FDA analysis, two or three of every 100 young people
who are treated with antidepressants may face elevated risk of
suicidal thoughts. No child or teen actually committed suicide
in the nine trials of antidepressants.
The FDA says the black box is only a warning for the potential
risk.
"The new warning language does not prohibit the use of antidepressants
in children and adolescents. Rather it warns of the risk of suicidal
(behavior) and encourages prescribers to balance this risk with
clinical need," the FDA said.
The medication packaging will also contain an information guide
advising parents to look for warning signs in their children.
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Understanding
depression |
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It is estimated that between 2 percent and 6 percent of all children
and adolescents suffer from depression -- a mood disorder in which
sad, lonely, irritable or weary feelings don't go away and prevent
a person from living a productive life.
"All I can see at that moment when I'm feeling depressed
is the problems and how I'm unhappy right now, and it seems like
it's not worth it. So it makes sense at that time, when I'm in
that mind state, to just end life as soon as possible," Chris
Drell, a 24-year old who was first diagnosed with bipolar disorder
when he was 11 years old, told the NewsHour.
 There
isn't a medical test for depression but researchers have linked
it to an imbalance of neurotransmitters -- the chemical messengers
that allow brain cells to communicate with each other.
One class of antidepressant drugs known as selective serotonin
reuptake inhibitors (SSRIs) work by increasing the levels of serotonin,
a neurotransmitter, in the brain. The drugs that were linked to
an increase in suicidal thoughts were all SSRIs.
In 2002 U.S. psychiatrists, as well as pediatricians and family
practitioners, wrote almost 11 million SSRIs and other antidepressant
prescriptions for children ages 1 to 17.
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| 'Off-label'
medications | |
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Much of the controversy stems from the fact that few antidepressants
were created for children. Instead, physicians prescribe them
for "off-label" use, meaning that although the drugs
have not been systematically studied for safety and effectiveness
in treating depression in children or adolescents, doctors still
give them to patients based on experience and medication knowledge.
 Only
Prozac is approved to treat some forms of depression in children.
Zoloft is approved for the treatment of another mental health
problem in children -- obsessive compulsive disorder. The drugs
might be safe and effective in treating children who suffer from
obsessive compulsive disorder, anxiety or other problems, according
to a study published in April by the British medical journal Lancet.
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Concerns
about new warning |
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Following the FDA announcement, the American Psychiatric Association
raised concerns over the new requirement, stating that the warning
may deter patients from using antidepressants.
"We restate our continued deep concern that a 'black box'
warning on antidepressants may have a chilling effect on appropriate
prescribing for patients. This would put seriously ill patients
at grave risk," the statement said.
They added that the number of people taking antidepressants has
decreased due to the recent controversy.
--
Compiled by Sheryl Silverman for NewsHour Extra
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