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February 3, 2004
For immediate release



Health Canada advises Canadians under the age of 18 to consult physicians if they are being treated with newer

OTTAWA - Health Canada is advising Canadians that patients under 18 who are currently being treated with a newer anti-depressant -- Selective Serotonin Re-uptake Inhibitors (SSRIs) or Serotonin Noradrenaline Re-uptake Inhibitors (SNRIs) -- should consult their treating physician to confirm that the benefits of the drug still outweigh its potential risks in light of recent safety concerns.

Health Canada recently requested that the manufacturers of the newer anti-depressants provide a thorough review of the worldwide safety data for their drug when used in children under 18 years of age. This request was made as a result of international reports that some of these drugs may be associated with an increased risk of suicide-related events in patients under 18 years of age.

It is important to note that Health Canada has not approved these drugs for use in patients under 18 years. The prescribing of drugs is a physician's responsibility. Although SSRI/SNRIs are not approved for use with children, doctors rely on their knowledge of patients to determine whether to prescribe them at their discretion in a practice called off-label use.

Health Canada does not advise that paediatric patients discontinue use of a newer anti-depressant without first consulting their treating physician, as treatment with these drugs should not be abruptly stopped due to the risk of discontinuation symptoms. This advisory does not apply to the approved uses of these drugs in adults.

This advisory applies to the following antidepressants:

  • Citalopram (Celexa®)
  • Fluoxetine (Prozac®)
  • Fluvoxamine (Luvox®)
  • Mirtazapine (Remeron®)
  • Paroxetine (Paxil®)
  • Sertraline (Zoloft®)
  • Venlaflaxine (Effexor®)


Media Inquiries:
Jirina Vlk
Health Canada
(613) 957-2988

Public Inquiries:
(613) 957-2991

Last Updated: 2004-02-06


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