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| Most
Antidepressants Deemed Unsafe for Children |
Posted:
04.26.04 | |
| Most
antidepressants are ineffective and may actually be unsafe for children and adolescents,
according to a study published in the April 24 edition of the British medical
journal Lancet.
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| With
the widespread use of drugs like Prozac and Paxil to treat depression, government
agencies and scientists have been studying whether children and adolescents who
use certain antidepressants are more likely to have suicidal thoughts or behaviors.
In the United States, the Food and Drug Administration is reviewing the issue
but has yet to reach any conclusions. | |
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| The
Lancet study | |
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| The
British study is a "meta-analysis" -- the first comprehensive scientific
review of both published studies and unpublished data that pharmaceutical companies
have said they own and have  the
right to withhold. The British government allowed the scientists access to the
unpublished, largely negative, data. The report concluded that young patients,
aged 5-18, should not take four popular antidepressants -- Paxil, Zoloft, Effexor
and Celexa -- because there was a clear risk of suicidal behavior among those
taking the drugs and no benefit. The fifth drug studied -- Prozac -- was found
to be effective for depressed children and did not have an elevated risk of suicide. The authors of the study
said the unpublished research had a major impact on the report's findings. "In
each of the published articles, the authors concluded the drug was either effective,
safe or both," said Tim Kendall, one of the authors of the study. "When
you look at the combined evidence, it is ineffective, unsafe or both." The
drug companies contend that their products are safe and deny they are risking
the lives of younger patients in order to sell more prescriptions. "The
use in children of our drug in particular, is a very, very, very small percentage
of the overall total prescriptions of this product," Mariann Caprino, spokeswoman
for Pfizer Inc., which makes Zoloft, told The Washington Post. "To suggest
that we are motivated by profiting off of children is ludicrous." | |
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| What
is depression? | |
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| It
is estimated that between 2 percent and 6 percent of all children and adolescents
suffer from depression. Depression is 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 in an upcoming report.
There isn't
a medical test for depression but researchers have discovered that those with
depression often have an imbalance of neurotransmitters -- the chemical messengers
that allow brain cells to communicate with each other. One class of antidepressant
drugs are known as selective serotonin reuptake inhibitors (SSRIs). They work
by increasing the levels of serotonin, a neurotransmitter, in the brain. These
increases can change a person's mood. All five antidepressants in the Lancet study
are 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 surrounding antidepressants and children is that few of the
drugs are specifically created for them. Instead, physicians prescribe them for
"off-label" use. Off-label means the drugs have not been systematically
studied  for
safety and effectiveness for the purpose the doctors prescribe them -- for example,
to treat depression in children or adolescents -- but can be given to patients
based on clinical experience and medication knowledge. Only Prozac is approved
for use in children to treat some forms of depression, which was the only issue
the researchers examined in the Lancet study. 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, the Lancet researchers
said. | |
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| Governments
respond | |
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| In
England studies like the one in Lancet and the growing concern of a link between
the antidepressants and suicide caused the British government to recommend against
most depressants, except Prozac, for children. On Thursday European Union
regulators recommended that Paxil not be given to children and adolescents.  In
the United States, the FDA has been more cautious. In March the agency requested
that drug manufacturers strengthen their warnings about the possible links between
the drug use by adolescents and suicidal thoughts and behaviors.
The agency
also asked an expert committee at Columbia University to review drug-company data
and to create a definition of what is suicidal thinking and suicidal behavior.
The report, due this summer, could influence any final FDA decision. --
Annie Schleicher, Online NewsHour | |
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