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Public advisory

Archive – Health Canada Advises Consumers about Important Safety Information on Atypical Antipsychotic Drugs and Dementia

Starting date:
June 15, 2005
Posting date:
June 15, 2005
Type of communication:
Source of recall:
Health Canada
Product Safety
Healthcare Professionals, General Public
Identification number:

Health Canada is advising Canadians about the risks to elderly patients suffering from dementia, who take second-generation antipsychotic medications, also referred to as atypical antipsychotics.

The advice is based on recent studies showing that elderly demented patients prescribed second-generation antipsychotic medications had a 1.6 greater death rate than those patients taking placebos (sugar pills).

The studies examined risperidone (Risperdal), quetiapine (Seroquel) and olanzapine (Zyprexa). There were no studies with clozapine (Clozaril) in elderly demented patients. However, because Clozaril is in the same family, this advisory applies to all four drugs.

Seroquel, Zyprexa and Clozaril are not approved for treating behavioural disorders in elderly patients with dementia. These three drugs as well as Risperdal are approved for the treatment of schizophrenia. Risperdal is also approved for the short-term treatment of aggression and/or psychosis in patients with severe dementia.

Based on the findings in the studies, Health Canada is requesting that all manufacturers of these drugs include a warning and description of this risk in the safety information sheet for each drug.

Patients should continue to take their medication as prescribed, as discontinuing any medication could pose health risks and should be discussed with a physcian. If patients have any concerns they should contact their doctor.

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