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Health professional risk communication

Atypical Antipsychotic Drugs and Dementia – Advisories, Warnings and Recalls for Health Professionals

Starting date:
June 22, 2005
Posting date:
June 22, 2005
Type of communication:
Dear Healthcare Professional Letter
Source of recall:
Health Canada
Important Safety Information
Healthcare Professionals
Identification number:

Notice about Health Canada advisories

[Text of letter begins]

Health Canada Endorsed Important Safety Information on Atypical Antipsychotic Drugs and Dementia

June 22, 2005

Subject: Increased Mortality Associated with the Use of Atypical Antipsychotic Drugs in Elderly Patients with Dementia

Dear Health Care Professional,

Health Canada is advising Canadians that treatment with atypical antipsychotic medication of behavioral disorders in elderly patients is associated with an increased risk for all-cause mortality. Except for risperidone (RISPERDAL), these medications are not approved for use in elderly demented patients.

Of a total of 13 placebo-controlled studies performed with risperidone (RISPERDAL), quetiapine (SEROQUEL) and olanzapine (ZYPREXA) in elderly demented patients with behavioral disorders, 10 studies showed numerical increases in all-cause mortality in the drug-treated groups compared to the placebo-treated groups. Overall, these studies enrolled a total of 3965 patients, showed a mean 1.6 fold-increase in death rate in the drug-treated patients. Most of the deaths were either due to heart related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).

All atypical antipsychotic drugs are approved for the treatment of schizophrenia. Risperidone (RISPERDAL) is also approved for the "short-term symptomatic management of inappropriate behavior due to aggression and/or psychosis in patients with severe dementia". There are no studies with clozapine (CLOZARIL) in elderly demented patients.

Because of the findings in the 13 studies, Health Canada is requesting that all manufacturers of atypical antipsychotic drugs include a warning of this risk in their Product Monograph describing this risk and noting that these drugs (except for RISPERDAL) are not approved for treating behavioral disorders in elderly patients with dementia.

The incidence of all-cause mortality observed in placebo-controlled clinical studies in behavioral disorders in elderly patients with dementia are:

Mortality Incidence in Elderly Subjects with Dementia in Placebo-Controlled Studies
Clozapine (CLOZARIL) Placebo Rispéridone
Placebo Quétiapine
Placebo Olanzapine
Number of Studies * 6 6 2 2 5 5
Incidence mortality: all causes/Number of all treated patients (#/N) * * 40/1009 22/712 20/365 7/217 42/1184 7/478
Percentage (%) * * 4 3,1 5,51 3,2 3,5 1,5

*No studies have been performed

The identification, characterization, and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse reaction reporting programmes. Any serious and/or unexpected reactions in patients should be reported to Health Canada at the following address:

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 (BCANS)
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]