Transcript Document

Antidepressants and Teen Suicide
By: Ann Kuharevicz
PHY111
Fall 2004
http://wildcat.arizona.edu/papers/97/124/03_2.html
The debate over the safety of antidepressants for children and
adolescents has raised considerable controversy. After years of
concerns about adequate testing of the effects of antidepressants
on minors, in June 2003, the FDA cautioned about the use of
antidepressants in children. This came only after British officials
noted an increased suicide risk among teens taking these drugs.
Since then, FDA officials have worked to assess the risk of teen
suicide from a number of antidepressants, and then determine
how to communicate those findings to doctors and patients. The
debate has provoked powerful opinions on both sides. What is
your opinion?
http://sfgate.com/cgi-bin/article.cgi?file=/c/a/2004/01/04/CM118608.DTL
Antidepressants & Teenagers: More
harm than good?
Facts and Stats
http://www.zoloft-side-effectslawyer.com/akathesia.htm
radio.cbc.ca/.../ archives/03-04/feb07.html
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Since the early 1990’s, the number of children in the U.S. taking
antidepressants has more than doubled.

It is estimated that children and adolescents make up about 8% of
patients prescribed antidepressant drugs in the U.S., constituting
over ten million prescriptions dispensed in 2003 for patients
younger than 18 years old.

Antidepressant prescription drugs developed for adults are
regularly prescribed to young people even though most have
never been specifically approved for use by depressed children
and adolescents.
Facts and Stats
price-rx.com/ order-effexor-37.5.shtml
price-rx.com/ order-paxil-10.shtml

Prozac is the only antidepressant approved by the FDA for use for
treating depression in pediatric patients.

The FDA denied manufacturers’ applications for approval to
prescribe Celexa, Effexor, Paxil, or Zoloft for patients under 18
years old because studies showed they were not effective.

Anafranil, Prozac, Luvox and Zoloft are approved for treating
obsessive compulsive disorder in pediatric patients.
There is no correlation
One side of the argument contends that there is no relationship
between the use of antidepressants and the risk of suicidal
thoughts and behavior in adolescents.
The depression itself is the fundamental cause of suicide in
teenagers. Prescribing antidepressants reduces the risk of
suicidality, suicidal thoughts and behavior.
http://www.zoloft.com/index.asp?pageid=7
Antidepressants have
reduced teen suicides
www.cnn.com/.../02/ 02/antidepressants.kids.ap/
In the last decade, a fall in adolescent suicide rates in the U.S. has
coincided with an increase in the use of drugs to treat depression.
Now, new study findings strengthen this association by showing
that these changes often occurred in the same geographical
regions.
"Suicide rates tended to be high in regions with high antidepressant
use," says lead author Dr. Mark Olfson, from Columbia University
in New York. "However, when we looked at changes that occurred
with time, a decrease in suicide rates in a particular region often
paralleled an increase in antidepressant use."
Overall, a 1% rise in antidepressant use by teens was accompanied
by a drop of 0.23 suicides per 100,000 adolescents per year.
Antidepressants have
reduced teen suicides
http://www.reuters.com/newsArticle.jhtml?type=topNews&storyID=6518050
A psychiatry professor at the University of Texas Southwest Medical
Center in Dallas, Dr. Graham Emslie, who conducted early studies
that found Prozac and Paxil effective in depressed teens and
children is not impressed with the published statistics. "It's not
convincing yet. There were no deaths in any of the clinical trials."
Postmortem studies also found that the "majority of kids who killed
themselves had no blood levels of medicine in them," the Dallas
professor added.
Moreover, Dr. Emslie said British authorities say the drugs have only
a 2 – 3% efficacy in minors. In contrast, his study found that 60%
of adolescents on antidepressants improved compared with a
40% improvement rate in those on placebos.
Antidepressants plus
therapy aid teen depression
www.windchimesyogafarm.com/
Therapy.htm
Researchers say that combining antidepressants with psychotherapy
(talk therapy) works best in treating depressed teens.
A study involving one of four treatments for 12 weeks was performed
on 439 depressed adolescents: 1) the combined treatment of
Prozac plus a form of psychotherapy, 2) Prozac-only, 3) behavior
therapy-only, and 4) placebos. Overall, 71% of patients on the
combined treatment, 61% of Prozac-only patients, 43% of
behavior therapy-only patients, and 35% of patients on placebos
had scores showing substantial improvement on a depression
rating scale.
Antidepressants plus
therapy aid teen depression
www.buddhanet.net/
psyche.htm
24 out of 439 patients exhibited suicidal tendencies. Study co-author
John Curry of Duke University said too few patients exhibited
suicidality to determine whether there truly are differences among
the treatments studied. "The first thing that needs to be clear is
that the overall rates are low" and that combining Prozac with talk
therapy seems to mitigate any suicidal risks, Dr. Curry said.
The study makes "a very important contribution" by showing that
there is effective treatment, said Dr. Thomas Insel, director of the
National Institute of Mental Health, which funded the study. "I
wouldn't in any way downplay the adverse events," Dr. Insel said.
But "just because a few kids develop this doesn't mean that you
don't treat anybody."
SSRIs are effective
www.chmeds.ac.nz/ research/gsfl/genetics.htm
An American College of Neuropsychopharmacology task force
concluded that SSRIs, selective serotonin reuptake inhibitors, do
not increase teens' risk of suicidal thinking or suicide attempts and
are effective in treating depression in this population.
The task force determined that SSRIs are the only antidepressant
drugs effective in treating depression in children and adolescents.
If anything, the panel concluded, the increased use of SSRIs
appears to have lowered the risk of suicide worldwide based on a
review of epidemiological studies from several countries. The
group noted that the rate of youth suicide in 15 countries had
declined by about 33% over the past 15 years, a period of time
that coincides with increases in SSRI prescribing rates.
SSRIs are effective
www.bbc.co.uk/wiltshire/ weather/sad3.shtml
Dr. Suzanne Vogel-Scibilia, a psychiatrist and mother of a teenager
on antidepressants, credits the drug Wellbutrin and another drug
for her son to handle mood swings and the anger that can
accompany them.
To Dr. Vogel-Scibilia, "the bottom line is that drugs to treat mental
illness, not to mention research to improve the drugs, are
important and that depression and other mental health problems
are under-diagnosed." She fears the suicide controversy will
simply scare more people away from getting care. "If you look at
suicides, the majority of them are not in treatment," she said.
"What's the cost of untreated mental illness?"
Her 15 year-old son, Tony, pleaded before an advisory committee for
the U.S. Food and Drug Administration, "Help me preserve my
future -- don't take away my medication.''
It’s not the drugs
"The most likely explanation for the episodes of attempted suicide
while taking SSRIs is the underlying depression," said Dr. Graham
Emslie.
Suicide is the third leading cause of death among young people and
depression and other psychiatric disorders are major causes of
suicide.
www.baltimorepsych.com/
cmbi.bjmu.edu.cn/ news/0402/24.htm
There is a correlation
Clinical studies revealed that various antidepressants do increase
suicidal thinking and suicide attempts in pediatric patients with
major depressive disorder (MDD).
In October 2004, the FDA ordered new warning labels for
antidepressants to explain the risk of suicidal behavior in youth.
The information must also state whether the drug has been
approved for use by children.
http://www.zoloft.com/index.asp?pageid=2
Violence and death
www.nature.com/nsu/ 030804/030804-11.html
www.irvingstudios.com/.../
MonumentLessons.htm
In 1990, Harvard researcher Martin Teicher and two colleagues
published a study in the American Journal of Psychiatry about six
patients who developed "violent suicidal preoccupation" after
taking Prozac for two to seven weeks. "It was remarkable how
violent these thoughts were," the authors reported. "Two patients
fantasized, for the first time, about killing themselves with a gun,"
they wrote, while one placed a loaded gun to her head. Another
had to be restrained to prevent self-mutilation, and another
fantasized about killing himself in a gas explosion. None of the
patients was suicidal when they started taking Prozac, the
researchers reported, and their obsession with violence and death
ended when they stopped.
The UK speaks out
http://www.paxil.com/about/nw_int.html
In June 2003, researchers in the United Kingdom issued a warning
urging doctors not to prescribe the antidepressant drug Paxil to
children and teenagers based on results of clinical trials.
A study of 1,100 children enrolled in clinical trials of Paxil showed
those taking the drug were nearly three times as likely to consider
or attempt suicide as children taking placebos. "There is an
increase in the rate of self-harm and potentially suicidal behavior
in this age group," said a statement from the British Medicines and
Healthcare Products Regulatory Agency (MHRA). "It has become
clear that the benefits (of Paxil) in children for the treatment of
depressive illness do not outweigh these risks."
The U.S. listens
www.exn.ca/Stories/ 2002/02/14/52.asp
Approximately one week later, the United States FDA warned that no
one under age 18 should be prescribed the drug for major
depression. It also announced that it would conduct a detailed
review of pediatric trials of Paxil. This review soon broadened to
include other antidepressants, including top sellers Prozac, Zoloft,
and Effexor.
In August, Wyeth Pharmaceuticals warned doctors that its drug,
Effexor, triggered hostile behavior or suicidal thinking in children at
twice the rate as the sugar pills taken as placebos.
The UK acts
http://www.msnbc.msn.com/id/6027819/
One month later, the MHRA announced that it was urging doctors to
stop prescribing a group of six antidepressants, including Paxil,
Zoloft, and Effexor because they caused an increase in suicidal
thoughts and actions. "These products should not be prescribed
as new therapy for patients under 18 years of age with depressive
illness," wrote Gordon Duff, chairman of the MHRA's Committee
on Safety of Medicines.
Prozac, the only SSRI approved for use in depressed children, was
not included in the new warning. The British review did not find a
significant increase in the risk of suicide-related events among
children taking the drug.
The U.S. follows
www.corporatemofo.com/
After 24 trials involving more than 4,400 patients taking
antidepressants, researchers found a greater risk of increased
suicidality during the first few months of treatment.
In these clinical trials, of nine antidepressants, none of the more than
4,400 children or teens actually committed suicide, but 4%
reported suicidality, compared with 2% of those who were given a
placebo.
Based on these findings, in October 2004, the FDA announced that
all nine of these drugs must carry a “black box” warning, the
strongest warning the United States can put on prescription drugs.
Drug companies & the FDA
www4.xpresssites.com/.../
hw/prescript3.gif
To understand how it got to this point, it is important to know how
the drug approval process works. When a drug company applies
to the FDA for approval to sell a medication, it must demonstrate
that the drug is safe and effective for a particular population, such
as adults, and a specific condition, such as depression. Once the
drug has been cleared by the FDA and is on the market, doctors
are free to prescribe it to anyone for any reason. "Off-label"
prescribing, is quite common. The only real restriction is that drug
companies cannot market drugs to unapproved groups. From
1987, when Prozac was first approved for adults, until early last
year, when Prozac became the first SSRI approved for use in
depressed children 7 and older, all antidepressants used by
depressed children were prescribed off-label.
Critics say the widespread use of antidepressants by children
amounts to an uncontrolled national experiment. The physicians
prescribing the drugs are often pediatricians or family doctors with
little or no training in psychopharmacology. The drugs are
frequently given in the absence of therapy. The subjects of the
experiment, the children, are too young to give meaningful
consent. There is little understanding of the long- term effect these
medications have on the structure of children's developing brains.
And the evidence that the drugs are effective is less than
impressive.
Biological solutions to behavioral problems have become increasingly
acceptable, even fashionable. It's simply become more acceptable
to see behavior as a reflection of an imbalance in chemistry rather
than an imbalance in life.
www.healingwithnutrition.com/ adisease/arthrit...
An uncontrolled experiment
SSRIs have been proven to cause a medical condition called
akathisia that is best described as severe agitation and a
compelling need to be in constant motion as well as by actions
such as rocking while standing or sitting, lifting the feet as if
marching on the spot, and crossing and uncrossing the legs while
sitting. People with akathisia are unable to sit or keep still,
complain of restlessness, fidget, rock from foot to foot, and pace.
This can be an extremely distressing experience and can lead
directly to mental confusion and suicidality.
David Healy, an internationally known psychopharmacologist from the
University of Wales College of Medicine, believes akathisia is the
principal trigger for impulsive violence in some people taking
SSRIs. "They became anxious, agitated, terrified, unable to sleep
at night and restless."
http://sfgate.com/cgi bin/article.cgi?file=/c/a/2004/01/04/CM118608.DTL
The side effects of SSRIs
Support works – drugs don’t
www.healthyplace.com/
newsletters/2.02.04.asp
Clinical trials, in both the U.S. and Britain, of Wellbutrin, Lexapro,
Paxil, Zoloft, and Effexor found these drugs to be no more
effective than placebos in treating depressed children.
Perhaps the most notable finding from clinical trials of
antidepressants is how many children respond well to placebos as many as 59 percent in some studies. This high placebo
response rate is a common finding in pediatric drug trials, in which
children are generally seen once or twice a week by clinicians.
“This suggests that simple support can help children in many
cases," Healy says.
What do you think?
www.gcrweb.com/.../ pages/falls-risks-intr.html
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There currently is no ban in the U.S. on prescribing
antidepressants to minors. Should there be?
If a ban were to be established, how do the children
get the help they need?
Would untreated depression, which itself is a risk factor
for suicide, possibly raise the rate higher than if treated
with antidepressants?
Could antidepressants lower the suicide risk in some
people while raising it in others?
Biblography
www.ijmt.net/ 3_4/3_4_26.html
www.toxlab.co.uk/SSRI.htm
Antidepressants and adolescent suicide. (October 2004.) Retrieved October 24, 2004 from
http://www.consumerreports.org-detailv4.jsp?-%3C%3Ecnt_id479121&FOLDER%3C%3Efolder_id162687&ASSORTMENT%3C%3East_id-333141
The Associated Press. (October 15, 2004.) New warning label ordered for antidepressants. Retrieved October 15, 2004
from http://www.msnbc.msn.com/id/625450/.
Johnson, Carolyn Y. What’s next for depressed kids? The Boston Globe. October 20, 2004.
Landers, Susan J. (Feburary 9, 2004.) Panel: SSRIs don't increase teen suicide risk. Retrieved October 24, 2004 from
http://www.ama-assn.org/amednews/2004/02/09/hlsb209.htm
Biblography
www.ijmt.net/ 3_4/3_4_26.html
www.toxlab.co.uk/SSRI.htm
Price, Joyce Howard. (February 8, 2004.) Antidepressants, teen suicide link questioned.Retrieved October 24, 2004
from http://www.washingtontimes.com-StoryID=20040208-123823-1958r.
Richwine, Lisa. (October 15, 2004.) US Orders New Youth Warnings onAntidepressants. Retrieved October 15,
2004 from http://www.reuters.com/newsArticle.jhtml?type=topNews&storyID=651805.
Snowbeck, Christopher. (October 5, 2004.) Antidepressants are a hot-button issue for teens. Retrieved October
24, 2004 from http://www.postgazette.com/pg/pp/390308.stm.
Waters, Rob. (January 4, 2004.) A Suicide Side Effect? What parents aren't being told about their kids‘
antidepressants. Retrieved October 24, 2004 from
http://sfgate.com/article.cgi?file=/c/a/2004/01/04/CM11860.DTL.