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Health professional risk communication

Archived - Important Safety Information on Strattera (atomoxetine hydrochloride) and the potential for behavioral and emotional changes, including risk of self-harm - Eli Lilly Canada Inc.

Starting date:
September 29, 2005
Posting date:
September 29, 2005
Type of communication:
Public Communication
Source of recall:
Health Canada
General Public
Identification number:

This is duplicated text of a letter from Eli Lilly Canada Inc.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

[Text of letter begins]

Public Advisory

Health Canada Endorsed Important Safety Information on Strattera (atomoxetine hydrochloride)

Date: 2005-09-29

Subject: Health Canada advises Canadians of new warning for STRATTERATM (atomoxetine hydrochloride)

TORONTO, Ontario - September 29, 2005 - Eli Lilly Canada Inc., following discussions with Health Canada is advising Canadians that Strattera™ (atomoxetine hydrochloride) will now carry a new warning. This new warning indicates that patients of all ages taking Strattera may experience behavioural and/or emotional changes that put them at increased risk of self harm.

The new warning for Strattera will appear in the information package received by patients and in the prescribing information available to health professionals.

Patients, their families and caregivers should note that a small number of patients taking Strattera may feel worse instead of better, particularly within the first few weeks of treatment or when doses are adjusted. For example, they may experience unusual feelings of aggression, hostility or anxiety, or have impulsive or disturbing thoughts that could involve self harm.

Should this happen to you, consult your doctor immediately. Do not discontinue your medication on your own. Treatment with Attention-Deficit/Hyperactivity Disorder (ADHD) medications is safest and most effective when the patient communicates well with the treating physician about how he or she is feeling.

Doctors are advised to carefully monitor patients of all ages for emotional or behavioural changes that may indicate potential for harm, including suicidal thoughts and the onset or worsening of agitation-type adverse events.

This advisory stems from a recent analysis of placebo-controlled studies with Strattera. The analysis showed that suicidal ideation was more frequently observed in clinical trials among children and adolescents treated with Strattera (5/1357 [0.37%]) compared to those treated with placebo (0/851).

Strattera is a selective norepinephrine reuptake inhibitor, indicated only for the treatment of Attention-Deficit Hyperactivity Disorder in children six years of age or older, adolescents and adults.


Eli Lilly Canada's Customer Response Centre 1-888-545-5972 (8:00 a.m. to 6:00 p.m. ET)


Stephanie Batcules

Eli Lilly Canada Inc.

(416) 693-3571

Strattera™ is a registered trademark of Eli Lilly and Company, used under license.

Eli Lilly Canada Inc.

3650 Danforth Avenue

Toronto, Ontario M1N 2E8


Tel.: 1-888-545-5972

Fax: 1-888-898-2961

Any suspected adverse reaction can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate


Address Locator: 0701C

OTTAWA, Ontario, K1A 0K9

Tel.: (613) 957-0337 or Fax: (613) 957-0335

To report an Adverse Reaction, consumers and health professionals may call toll free:

Tel: 866 234-2345

Fax: 866 678-6789

For other inquiries, please refer to contact information:

Bureau of Cardiology, Allergy and Neurological Sciences


Tel.: (613) 941-1499

Fax: (613) 941-1668

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

[Text of letter ends]

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