[drugawareness] Canada Issues Stronger Warnings on Antidepressants

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atracyphd2

Fri, 4 Jun 2004 13:31:46 EDT

[drugawareness] Canada Issues Stronger Warnings on Antidepressants

 

 

Canadian authorities have issued strong warnings on antidepressants for those

of ALL AGES - warnings of behavioural and emotional changes along with an

increased risk of harming themselves or others.

 

This warning comes in the wake of the New York Attorney General filing suit

against the makers of Paxil the day before.

 

I encourage you to get all of this information coming out in the past few

weeks to your state authorities and local reporters.

 

Ann Blake Tracy, Ph.D.

Executive Director, International Coalition For Drug Awareness

Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare

& audio tape on safe withdrawal: " Help! I Can't Get

Off My Antidepressant! "

 

Order Number: 800-280-0730

Website: www.drugawareness.org

 

 

http://www.cbc.ca/stories/2004/06/03/antidepressant040603

 

Health Canada strengthens antidepressant warning

 

Last Updated Thu, 03 Jun 2004 18:52:43 OTTAWA - People of all ages who take

newer antidepressant drugs may experience behavioural and emotional changes

that may increase the risk of harming themselves or others, Health Canada warned

Thursday.

 

The department strengthened its warning about Selective Serotonin Re-uptake

Inhibitors (SSRIs) or Serotonin Noradrenalin Re-uptake Inhibitors (SNRIs).

 

The advisory applies to:

Bupropion (Wellbutrin and Zyban)

Citalopram (Celexa)

Fluoxetine (Prozac)

Fluvoxamine (Luvox)

Mirtazapine (Remeron)

Paroxetine (Paxil)

Sertraline (Zoloft)

Venlaflaxine (Effexor) A small number of patients taking the drugs may feel

worse instead of better, the advisory said.

 

Doctors, patients, families and other caregivers should be on the lookout for

signs of suicidal thoughts or worsening depression, such as hostility,

anxiety or insomnia, especially when a patient begins the drug therapy or

whenever

the dose is changed.

 

If someone feels worse, they should consult a doctor immediately. It is very

important that patients do not stop taking their medication without first

consulting a doctor, the advisory stressed.

 

FROM : U.S. expands antidepressant warning

 

In February, Health Canada advised patients under the age of 18 who were

being treated with the SSRIs to consult a doctor. Thursday's stronger advisory

is

similar to a U.S. warning issued earlier this spring. Drug regulators in the

U.K. have banned the use of most SSRIs in children.

 

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Jun. 4, 2004. 06:25 AM

 

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.