Are mood drugs helping our kids? ROBIN
HARVEY LIFE WRITER
From
all appearances Gareth Christian was an artistic, intelligent
young man with a great sense of humour, excited at the
prospect of starting his own snowboarding company.
So when the 18-year-old Vancouver resident committed
suicide in January, 2002, his friends and family were shocked.
"He was just so loved in the community," says his
mother Leslie Fenn Christian. "About 1,400 people came to his
funeral."
She is convinced her son's death was linked to the SSRI
antidepressant medication he had first been prescribed when he
was 17 — pills that the U.S. drug watchdog this week declared
in need of stiffer warning labels for adults and children
because they may increase the risk of suicide in some
patients.
Christian had been on the medication for six months
after experiencing a mild bout of depression. But several
weeks before his death, he stopped taking it because it made
him agitated and aggressive.
"They never tapered him off and he had an extreme
reaction," she says. "It seemed he was getting better and then
... that was it."
Though the grieving mother tried to find out if the
drug was a possible cause of her son's suicide, she could
never get a definite answer.
The U.S. Food and Drug Administration warning is
another step taken by regulatory bodies and medical experts
worldwide to address concerns that the pills may be linked to
suicide, violence and aggression among patients 18 and under.
This week, Health Canada announced it will require drug
makers to change the labelling on the drugs to include
stronger warnings about concerns related to possible suicide
by those 18 and under.
The drugs — citalopram (Celexa), fluoxetine (Prozac),
fluvoxamine (Luvox), mirtazapine (Remeron), paroxetine
(Paxil), sertraline (Zoloft), venlaflaxine (Effexor) — are not
approved for use in people under 18 in Canada. But they have
been increasingly prescribed for this group "off-label."
Doctors who have been prescribing the pills to patients under
18 will still be allowed to do so.
That means a doctor can prescribe them for children if
he or she believes it will be of benefit. Most of the drugs
are prescribed by family doctors and pediatricians as there
are so few child psychiatrists in Canada.
"No one told us that the drug was not approved for
young people," says Fenn Christian. "No one ever warned us
there could be unusual ... side effects."
Figures from the medical research firm, IMS Canada,
show the number of times SSRIs were recommended for children
in this country over the past five years has increased
significantly. Last year, SSRIs were recommended to pediatric
patients 522,000 times. That compares to 343,000 times in
1998.
Health Canada cautions that no one should abruptly stop
taking any of these medications as they must be cut back
gradually to avoid potential serious withdrawal effects. It
has also asked the manufacturers of the drugs for a thorough
review of the worldwide safety data for their use in children.
It convened a special scientific advisory panel in February
and will release its recommendations at the end of the month.
The FDA has alerted doctors and patients to watch for
signs of suicide during the first few weeks the drugs are
prescribed and whenever their dose is changed. The move comes
after a hearing last month when scores of parents reported how
their children became suicidal or violent after taking the
drugs.
Because suicidal thoughts are common among depressed
patients, many experts say it is impossible to tell if the
drugs or the disease is the cause.
Still, Dr. Jane Garland, clinical head of the Mood and
Anxieties Disorders Clinic at British Columbia's Children's
Hospital, says there is definitely a subgroup of pediatric
patients who experience obsessive suicidal thoughts after
going on the medication.
"I had a 16-year-old patient on (an SSRI) call me
shortly after she began taking it and she was overwhelmed by
the thoughts of suicide and self harm she began feeling,"
Garland says. The patient had never experienced such severe
thoughts of self-harm before taking the drug, Garland says.
She believes the drugs "tweak" certain mechanism in the
brain that may reduce or increase suicidal tendencies in
specific groups of patients. It has been documented that even
some normal people who are not depressed will become obsessed
by thoughts of suicide and self-harm when put on the
medications, she says. She thinks doctors can use the drugs,
but only if the patient is at severe risk due to their
psychiatric condition and after other measures — such as
cognitive therapy, improved diet, exercise and sleep fail to
achieve results.
Many doctors were upset this past year when they found
out drug companies did not report studies that showed the
drugs were not effective in pediatric patients. Since the
drugs were already approved for adults they were not obliged
to report the negative data from studies of pediatric
patients, Garland says.
But not reporting such data puts doctors "in a very
awkward position" says Kathryn Clarke, spokesperson for the
Ontario College of Physicians and Surgeons. Doctors need that
information to make an educated choice about prescribing the
drugs, she says.
However, spokespersons for makers of three of the drugs
— Paxil, Luvox and Remeron — say they have obeyed all laws and
regulations.
"This is not penicillin where we can see in a test tube
how it works," says Dr. Clive Chamberlain, adolescent suicide
expert with the Centre for Addiction and Mental Health, who
was a member of Health Canada's scientific advisory panel
looking into the use of the drugs on pediatric patients.
Chamberlain says there is not enough research into the
effectiveness of the drugs in people under 18. However, he
says anecdotal and clinical reports show they do help many
people. But the reports of suicidal thinking and violence and
aggression on the drugs are also anecdotal, he says.
Doctors are put in a difficult position where they have
to weigh possible adverse effects from medication in a
depressed young patient, including the real risk of suicide,
against possible benefits. Chamberlain says he believes the
drugs do work for many pediatric patients but they must be
monitored very carefully.
He says more independent research — research not funded
by drug companies — is needed to determine if, how and when
the drugs should be used.
Dr. Mark Sanford, head of the child mood disorder
service at the Centre for Addiction and Mental Health, says
though there is a "great deal of alarm" the dangers are
probably exaggerated.
Sanford says "40 to 60 per cent of patients" 18 and
under who are severely depressed will be actively suicidal at
some time. He says it is important to conduct more research on
the use of the drugs in children. He points out that in his
clinical experience the drugs do help many patients.
Patients such as Jonathan Singh, 18, who has been
taking an SSRI for a year for depression, say the drugs work
wonders. The Toronto area youth says the drug has "turned my
life around." Before he took it he was so depressed, he failed
a year at school.
No one really knows how the drugs work but they are
believed to alter the chemistry of neurotransmitters —
serotonin, norepinephrine and dopamine — in the brain. And
because studies have shown about 80 per cent of pediatric
patients prescribed drugs for depression get better on
placebo, it is hard to tell how effective they are.
But last month, Garland wrote in the Canadian
Medical Association Journal that the evidence showing
SSRIs work in children is "weak or non-existent." She says
that observations in some clinical trials and case reports
show up to 25 per cent of children placed on SSRIs for any
disorder will have other adverse psychiatric effects including
agitation, irritability and out of character behaviour.
A trial of adolescents on one SSRI found 10.5 per cent
stopped because of serious psychiatric effects — the most
common being "suicidal ideation/gestures, conduct problems or
hostility and aggressiveness," she says.
Another concern among doctors is the number of children
on the drugs who are taking more than one psychoactive
medication. A study by the American Psychological Association
found 42 per cent of children are given two or more
medications affecting their central nervous system and 10 per
cent were prescribed two or more antidepressant medications.
Fenn Christian says no unapproved drugs should be used
on minors unless the patient and parents are informed of all
possible problems. She wants the drugs prescribed only by
specialists in pediatric psychiatry.
Though the FDA did not conclude the drugs cause
suicide, it warned that emerging or worsening thoughts of
suicide "might be a result of drug therapy." It also warned
that "anxiety, agitation, panic attacks, insomnia,
irritability, hostility, impulsivity, (severe restlessness),
hypomania, and mania" were reported in children and adults on
the drug. Patients with these symptoms "may be at increased
risk for worsening depression or suicidality ... . Medications
may need to be discontinued, when (such) symptoms are severe,
abrupt in onset" or not present before the drugs were begun,
it warned.
A spokesperson for the makers of Paxil, GlaxoSmithKline
Inc., says the firm is committed to working with the FDA,
Health Canada and other medical experts. The firm discloses
all data about its products to health officials and drug
regulators as soon as possible, the spokesperson says.
A spokesperson for Solvay Pharma Inc., the maker of
Luvox, says the firm has provided Health Canada with all the
data it requires on the use of the drug in children.
A spokesperson for Organon Canada Ltd., which makes
Remeron, says some of the symptoms that sparked the label
change do not occur in Remeron. The drug is not associated
with an increase in suicidal thoughts, it says.
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