Advisory
2005-63
June 15, 2005
For immediate release
Health Canada advises consumers about important safety information on atypical antipsychotic drugs
and dementia
OTTAWA - 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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Media Inquiries:
Jirina Vlk
Health Canada
(613) 957-2988
Public Inquiries:
(613) 957-2991
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