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CHILDREN
TAKING ANTIDEPRESSANTS: What are the
risks?
15-year-old
boy's murder trial adds fuel to debate
over use of 'Zoloft defense.'
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STAFF
PHOTO BY DAVID BERGELAND
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Activist
Lisa Van Syckel of
Raritan
Township
sits with pictures of
Christopher Pittman, who
was convicted of murdering
his grandparents but said
Zoloft caused him to do
it. After her daughter
attempted suicide in 2000
after she stopped taking
Paxil, Van Syckel started
fighting to spread the
word about the potentially
dangerous effects of
antidepressants on
children.
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RECOMMENDED
PRECAUTIONS WARNING SIGNS DRUGS
APPROVED FOR CHILDREN'S USE THE
RISK OF SUICIDAL THOUGHTS OR
ACTIONS
Pay close attention to changes in
your child's moods or actions,
especially if the changes occur
suddenly. Other important people
in your child's life can help by
paying attention as well (e.g.,
brothers and sisters, teachers and
other important people).
Whenever an antidepressant is
started or its dose is changed,
pay close attention to your child.
After starting an antidepressant,
your child should generally see
his or her health-care provider:
·
Once
a week for the first four weeks
·
Every
two weeks for the next four weeks
·
After
taking the antidepressant for 12
weeks
·
After
12 weeks, follow your health-care
provider's advice about how often
to come back
·
More
often if problems or questions
arise
You should call your child's
health-care provider between
visits if needed.
Source:
Medication Guide approved by the
U.S.
Food and Drug Administration
If your child is taking an
antidepressant, contact your
health-care provider right away if
he or she exhibits any of the
following signs for the first
time, or if they seem worse, or
worry you, your child or your
child's teacher:
·
Thoughts
about suicide or dying
·
Attempts
to commit suicide
·
New
or worse depression
·
New
or worse anxiety
·
Feeling
very agitated or restless
·
Panic
attacks
·
Difficulty
sleeping (insomnia)
·
New
or worse irritability
·
Acting
aggressive or being angry or
violent
·
Acting
on dangerous impulses
·
An
extreme increase in activity and
talking
·
Other
unusual changes in behavior or
mood
Never let your child stop taking
an antidepressant without first
talking to his or her health-care
provider. Stopping an
antidepressant suddenly can cause
other symptoms.
Source:
Medication Guide approved by the
U.S.
Food and Drug Administration
Of all antidepressants, only
fluoxetine (Prozac) has been
FDA-approved to treat pediatric
depression.
For obsessive compulsive disorder
in children and teenagers, the FDA
has approved fluoxetine (Prozac),
sertraline (Zoloft), fluvoxamine,
and clomipramine (Anafranil).
Your health-care provider may
suggest other antidepressants
based on the past experience of
your child or other family
members.
Source:
Medication Guide approved by the
U.S.
Food and Drug Administration
Children
and teenagers sometimes think
about suicide, and many report
trying to kill themselves.
Antidepressants increase suicidal
thoughts and actions in some
children and teenagers.
But suicidal thoughts and actions
can also be caused by depression,
a serious medical condition that
is commonly treated with
antidepressants. Thinking about
killing yourself or trying to kill
yourself is called suicidality or
being suicidal.
A large study combined the results
of 24 different studies of
children and teenagers with
depression or other illnesses. In
these studies, patients took
either a placebo (sugar pill) or
an antidepressant for one to four
months.
No one committed suicide in these
studies, but some patients became
suicidal. On sugar pills, two out
of every 100 became suicidal. On
the antidepressants, four out of
every 100 patients became
suicidal.
For some children and teenagers,
the risks of suicidal actions may
be especially high. These include
patients with:
·
Bipolar
disorder (sometimes called
manic-depressive illness)
·
A
family history of bipolar disorder
·
A
personal or family history of
attempting suicide
If any of these are present, make
sure you tell your health-care
provider before your child takes
an antidepressant.
Source:
Medication Guide approved by the
U.S.
Food and Drug Administration
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ASSOCIATED
PRESS PHOTO
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Pittman,
15, listens to his
sentencing Tuesday in a
Charleston
,
S.C.
, court. He received 30
years in prison for
killing his grandparents.
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STAFF
PHOTO BY DAVID BERGELAND
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Lisa
Van Syckel of
Raritan
Township
sorts through paperwork
related to antidepression
drugs at her home. Van
Syckel is one of several
advocates who are pushing
health officials,
drug-makers and parents to
be aware of the
potentially dangerous
effects of antidepressants
on children.
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By
STEFANIE MATTESON
Staff Writer
RARITAN
TWP. -- On Mother's Day, it was Lisa Van
Syckel who Christopher Pittman called.
When he went to court, it was Lisa Van
Syckel who bought him an oxford-cloth
shirt and khakis to wear. And when he was
convicted of murdering his grandparents,
it was Lisa Van Syckel who cried like the
mother he never had.
An
activist who has fought the
overprescribing of antidepressants to
children, Van Syckel, of
Raritan
Township
, has served as a surrogate mother to
15-year-old Pittman for 18 months, talking
with him at least once a day. She
maintains it wasn't Pittman who killed his
grandparents -- it was Zoloft, the
antidepressant he had been prescribed.
"I
just can't believe it," she said
tearfully after his conviction Tuesday.
"It's a very sad story. A child was
convicted when it is the pharmaceutical
company that should have been
convicted."
The
Charleston
,
S.C.
, trial of Pittman, who was sentenced to
30 years in prison, is the first case
involving a youngster who said an
antidepressant caused him to kill -- the
so-called Zoloft defense. Pittman was
charged as an adult for shooting his
grandfather in the mouth and his
grandmother in the head as they lay
sleeping.
He
had been taking Paxil and then Zoloft for
mild depression for about four weeks
before the murders, with the dose being
doubled from 100 milligrams to 200
milligrams three days before, Van Syckel
said.
But
prosecutors called the Zoloft defense a
smoke screen, saying Pittman, who was 12
at the time, knew what he was doing when
he shot his grandparents three years ago,
then set fire to their house and drove off
in their car, allegedly in anger at their
disciplining of him for choking a younger
student on a school bus.
New
developments
While
the Pittman trial may have heightened
general awareness of the issue,
antidepressant safety has long been the
subject of vigorous debate among
mental-health professionals, patients,
parents and advocates. New developments
appear to guarantee that the controversy
will continue:
·
The FDA's "black box warning,"
its most severe, on drugs known as
selective seratonin reuptake inhibitor (SSRI)
antidepessants goes into effect this
month. The warning says that the risk of
suicidal thoughts and behavior in children
and adolescents during the first few
months of treatment is 4 percent -- twice
the placebo risk of 2 percent.
·
The British Medical Journal, in an
editorial published Saturday, concluded
the "balance between benefits and
harms seems to be negative," that
there is "little evidence of
efficacy" and that physicians should
be discouraged from routinely prescribing
the drugs to children and adolescents.
·
A new 17-member state Teen Suicide
Advisory Council, which met for the first
time last month, has been formed to
educate teenagers and their parents about
suicide. Another aim is to collect
concrete data on how many teenagers in the
state attempt suicide and how many
complete it.
·
In an effort to quell mounting parental
anxiety, a coalition of 13 mental-health
organizations, including the American
Psychiatric Association, launched an
online resource center,
ParentsMedGuide.org, on Feb. 1 to answer
questions on the risks of antidepressant
use among children and adolescents.
The
recent events have stiffened the resolve
of parents such as Van Syckel to spread
the message of the drugs' dangers. Their
efforts have already been partly
responsible for the new black box warning,
which was ordered in October.
Though
the risks described in the warning are
small, parents such as Laurie Yorke of
Clark, whose son, Ryan, then 16, attempted
suicide when coming off the antidepressant
Paxil, point out that with 11 million
prescriptions for antidepressants being
written out for children under 18 in 2002,
the risk translates to "a lot of
kids."
Despite
the fact that the warning hasn't yet
started to appear, it is already reducing
demand. During the last three months of
2004, the rate of patients under 18 who
were prescribed antidepressants dropped 16
percent compared with the same time period
in 2003, according to pharmacy benefit
managers Medco Health Solutions.
Parents
get involved
Van
Syckel became involved in 2000 after her
daughter, Michelle, then 15, attempted
suicide after she had stopped taking Paxil
for symptoms diagnosed as depression and
anorexia that turned out to be Lyme
disease. Michelle, 19, is now a college
student who wants to put the episode
behind her, her mother said.
Paxil,
made by GlaxoSmithKline, is an SSRI
antidepressant, a subset that also
includes Zoloft, made by Pfizer, and
Prozac, made by Eli Lilly & Co.. The
drugs act by increasing levels of
serotonin, a chemical that is linked with
mood, in the brain and body.
And
while the FDA has ordered the warning,
parents such as Van Syckel say it isn't
enough. They have formed an informal
network whose goal is to educate the
public about the perils of the drugs.
"Parents are desperate for
answers," she said.
Yorke
is a parent who wishes she had known more.
She wrote off the changes in her son's
behavior -- insomnia, aggression, a
decline in his grades -- to being a
teenage boy. Despite being a nurse, she
didn't realize Ryan's changes could be due
to the Paxil he had been prescribed for a
panic attack until she started doing
research.
Her
discovery that Paxil might be causing the
symptoms led her -- at the advice of his
doctor -- to wean him from the drug. On
March 3, 2004, three weeks into the
weaning schedule, Ryan, 16, emerged from
his bedroom wielding a knife in a
"full-blown Paxil rage," she
said. "I want everybody dead,"
he said before slashing his wrists.
"I'm
lucky, because he's alive," she said.
Ryan
has been off the drug for nearly a year.
"He's my kid again," his mother
said, referring to the teenager he was
before he started taking Paxil. Though he
has been receiving home instruction since
he started the weaning process, he hopes
to return to
Arthur
L.
Johnson
High School
in September for his senior year.
He
has never had another panic attack.
"Paxil
has taken a lot away from him," she
said. "He'll be stronger in the end,
but it's been a hell of a couple of years.
No child should have to go through
this."
"My
position is that the FDA is still dragging
its feet, that they're not protecting the
citizens and that they're kowtowing to the
drug companies," said Robert Scott
Fritz, of Long Beach Township, whose
daughter, Stephanie, committed suicide in
2003 at age 16 after taking Zoloft for 10
weeks.
Although
Stephanie was unhappy, she wasn't
suffering from major depression, he said.
She swam on the varsity swim team, played
junior varsity tennis, was a member of
three youth groups and was taking voice
and guitar lessons. She was scheduled to
sing at The Stone Pony in Asbury Park
shortly after her suicide.
"She
never should have been on
medication," he said.
"Unfortunately, we bought the line:
you take a pill, and you feel
better."
The
activists say the drugs are prescribed to
teenagers to lift their mood and for
reasons unrelated to depression by
primary-care physicians who aren't
knowledgeable about the risks. The APA
confirms that 70 percent of such
prescriptions are written by primary-care
physicians rather than psychiatrists.
The
activists also say that physicians aren't
monitoring their patients -- not only for
suicidal thoughts and behavior, but also
for agitation, irritability and other
changes in behavior -- nor are parents
being warned to do so. They say such
agitation can lead to violence among those
who take the drugs, as in Christopher
Pittman's case.
Moreover,
they say these risks are being incurred
for drugs whose effectiveness in treating
depression in children has never been
demonstrated. They say the studies that do
indicate the drugs are effective have been
compromised by the researchers' links with
the pharmaceutical companies that
manufacture them.
Risks
of depression
The
drug companies and many mental-health
professionals, on the other hand, argue
that the risk of suicide for teenagers
taking SSRIs is smaller than it would be
without them and that the drugs save lives
by treating depression. Suicide is the
third leading cause of death among
teenagers, after homicide and accidents.
Matthew
Rudorfer of the National Institute of
Mental Health, who was among those on an
FDA advisory panel who voted against the
warning, pointed out that while the risk
of being suicidal is increased 2 to 3
percent among children and adolescents
taking the drugs, the underlying illness
carries a 15 percent risk of suicide if
left untreated.
"As
part of a comprehensive treatment plan,
antidepressants can be extremely helpful
for many young people struggling with
depression, an illness with significant
long-term consequences, including an
increased risk for suicide," the APA
has said in a formal statement.
The
APA has said the warning may have a
chilling effect on appropriate
prescribing, thus putting seriously ill
patients at risk. They have also said the
negative publicity may prompt some
patients to stop taking the drugs, with an
abrupt withdrawal potentially causing
serious side effects.
"We
believe the biggest threat to a depressed
child's well-being is to receive no care
at all," APA spokesman Jason Young
said.
The
APA points to a recent federally-funded
study of adolescents with depression,
which found in part that patients
responded positively to a combination
treatment -- an SSRI plus
Cognitive-Behavior Therapy, a form of talk
therapy, at a rate of 71 percent -- double
the 35-percent response rate for patients
taking a placebo.
But
Vera Sharav, president of the Alliance for
Human Research Protection, a watchdog
group that tracks the results of clinical
trials, points out that six patients who
were taking Prozac attempted suicide
during the trial, compared to one on the
placebo.
The
APA also points to data from the Centers
for Disease Control and Prevention showing
a 25 percent decline in the suicide rate
among American youths ages 10 to 19
between 1992 and 2001 -- a 10-year period
that corresponds to a marked increase in
the prescribing of SSRI antidepressants to
that age group.
But
Sharav takes issue with those figures,
saying that evidence of a correlation is
not evidence of causation.
"It's
junk science," she said, pointing out
that the decline in suicide rates could be
linked with any number of factors other
than the increase in the use of
antidepressants, including the restriction
on handguns imposed by the Brady bill,
which took effect in 1994.
More
children taking antidepressants
Though
the issue of children and antidepressants
is fraught with controversy, what is not
in dispute is the growth in the numbers of
children taking such drugs.
Between
1994-96 and 2000-02, the annual number of
doctor visits by children between 5 and 17
at which an antidepressant was prescribed
nearly tripled -- from 1.1 million to 3.1
million with the rate for adolescents
twice as high as for younger children,
according to a 2004 National Center for
Health Statistics report.
The
report, "Health, United States,
2004," which contains a special
section on prescription drug use, said
that in 2000-02, 8.8 percent of
adolescents ages 12 to 17 were prescribed
antidepressants. Nearly 70 percent of
those prescriptions were for SSRIs, the
report said.
The
report also pointed out that pediatric use
of such drugs is often "off
label," which means that because of
the limited number of studies on children,
physicians prescribe them on the basis of
studies in adults. Only Prozac has been
approved by the FDA for use in children.
Though
Van Syckel settled a lawsuit with Paxil's
manufacturer, GlaxoSmithKline, in
December, she isn't stopping there. Armed
with stacks of pharmaceutical company
documents describing the drugs' side
effects, she is accusing the companies of
putting children's lives in danger by
withholding vital information from the
public.
"I
say I have ODD -- oppositional defiance
disorder," she says. "I'm
fighting everyone on this issue."
Van
Syckel has written the president, the
governor and her congressman and senators.
She testified at FDA hearings on SSRIs
last February and September and attended
Congressional hearings in September in
which pharmaceutical company executives
and FDA officials were grilled about a
possible cover-up. She also took up the
cause of Pittman, who refers to her as
"Mrs. Lisa."
"I
wanted to know what the pharmaceutical
companies knew, when they knew it and what
kind of tactics they're using (to suppress
information)," she said. "The
fact that they would withhold from the
American public the fact that these drugs
can cause someone to kill themselves is
horrific."
With
other parents who testified at the FDA
hearings, including Yorke, Syckel has
formed the International Coalition for
Drug Awareness, an activist group that
keeps in touch via the Internet. Members
wear silver ribbons with a rose
symbolizing the children who have been
harmed or died from SSRI use.
Fritz
has also become an activist -- for suicide
prevention. His daughter is one of eight
teenagers in Monmouth County who have
committed suicide in the last 16 months --
an average of one every two months --
compared to two in the previous four
years. He believes the increase is linked
to antidepressant use.
With
a close friend whose son also committed
suicide while on antidepressants, Fritz
has brought the suicide prevention
program, Yellow Ribbon International, to
New Jersey. The organization aims to
educate teenagers and their parents about
what to do if they feel they want to harm
themselves.
He
has also been appointed to the New Jersey
Teen Suicide Advisory Council. The aim of
the council is to educate families about
what to do if a teenager expresses
suicidal thinking -- talk therapy being
the first step -- and what to look for if
a teenager is prescribed antidepressants.
"Some
docs aren't telling parents what they need
to know," Fritz said, referring to
the changes in mood and sleep patterns and
especially the violent dreams that
preceded his daughter's suicide.
The
council is also trying to get firm figures
on how many teenagers in the state attempt
suicide and how many complete it. The
establishing legislation says that fewer
than 25 percent of suicide attempts are
reported, diminishing the accuracy and
amount of the information available.
"Suicide
is a taboo subject," Fritz said.
·
Stefanie
Matteson can be reached at (908) 707-3136
or smatteson@c-n.com.
AT
A GLANCE: For
more information on adolescents and
antidepressants, visit www.drugawareness.com
or e-mail Lisa Van Syckel at lvansyckel61@yahoo.com.
For Yellow Ribbon International, visit www.yellowribbon.org.
from
the Courier News website www.c-n.com
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