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Jun. 4, 2004. 06:25 AM
 
Jim Coyle  
Rosie Dimanno  
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Royson James  
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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