Health Canada, the Canadian regulatory agency similar to the Food and Drug Administration in the United States, has issued a request to manufacturers of certain atypical anti-psychotic medications to include a warning in certain medication labeling for elderly patients with dementia. Recent studies of these types of drugs, which are second-generation anti-psychotic medications usually prescribed for schizophrenia, have shown that elderly patients with dementia had a 1.6 time higher death rate that other elderly patients when taking the drugs Seroquel, Zyprexa, and Risperdal. While no studies were done with the anti-psychotic drug Clozaril, a similar drug, Health Canada has requested that Clozaril labeling also contain a warning.

Seroquel, Zyprexa and Clozaril are not approved in Canada for treating patients with dementia but are approved for use with schizophrenic patients. Prescribing a drug for uses other than its approved indication, a practice known as “off-label” prescribing in the U.S., may cause harm to patients.

Sources: Anne Winstanley, Toronto 680 News, June 15, 2005; Canadian Press, June 16, 2005.