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| Jun. 4, 2004. 06:25 AM |
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Warnings slapped on anti-depressants
Doctors told to look for suicide signs
Concern rises
over drug use by youth
RITA
DALY
STAFF REPORTER
Canadian doctors have received strong warnings from
seven drug companies to watch for signs of increased risk of
suicide among children, adolescents and adults who are
prescribed a popular class of anti-depressants.
Altogether nine drugs, including Prozac, Paxil, Celexa
and the anti-smoking drug Zyban that is also an
anti-depressant, have been slapped with the new warnings in
`Dear Doctor' letters approved by Health Canada, following
discussions about wording with the companies. The drug makers
also must increase the warnings on their products.
The letters were sent out this week and were also
posted yesterday on the Canadian Medical Association
Journal Web site.
It's the latest step taken by Health Canada, the
country's health watchdog, to address the growing concern
worldwide about the use of anti-depressants, particularly
among those younger than 18.
An advisory was issued earlier this year, following
separate warnings in Britain and the United States last summer
regarding the use of anti-depressants in children.
"Doctors are advised to carefully monitor patients of
all ages for emotional or behavioural changes that may be
potential for harm, including self-harm," Health Canada
spokesperson Jirina Vlk said yesterday.
Seven of the nine drugs are members of a new class
known as selective serotonin reuptake inhibitors (SSRIs) and
include: fluvoxamine (Luvox), paroxetine (Paxil), sertraline
(Zoloft), mirtazapine (Remeron), fluoxetine (Prozac),
venlafaxine (Effexor) and citalopram (Celexa). Wellbutrin and
Zyban, derived from the active ingredient bupropion, are not
SSRIs but are included in the new warnings.
All have been approved for use in Canadian adults but
are often prescribed "off-label" to children and adolescents.
"Do the benefits outweigh risks? That's the medical assessment
doctors have to make," Vlk said.
The new warnings here coincide with a lawsuit launched
this week by the New York Attorney-General against
GlaxoSmithKline, claiming the British drugmaker misrepresented
data about Paxil's safety and effectiveness in patients
younger than 18. The suit also claims Glaxo conducted at least
five studies on Paxil in children and adolescents but only
published one. Glaxo has denied allegations in the lawsuit.
Health Canada's advisory in February and the current
warnings were prompted by its advisory panel's request to the
seven drug companies, including Glaxo, to see all worldwide
safety data in their possession — published or not — related
to anti-depressant use in children.
Glaxo spokesperson Jill McKinlay-Morris said all
pediatric studies were made available to Health Canada.
Depression is Canada's fastest rising diagnosis and an
estimated one million Canadians suffer some form of
depression.
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