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Posted: June 03, 2008

Antipsychotic Drug Use in Elderly with Dementia Triples Risk of Death

The elderly with dementia run more than three times the risk of death or hospitalization from short-term use of antipsychotic drugs to control their agitation than demented patients who don’t use the drugs, researchers say.

The effects happen quickly, the researchers report, with death or hospitalization often occurring within a month of taking the antipsychotic drugs. The findings were reported in the journal Archives of Internal Medicine.


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Antipsychotic drugs are often prescribed as a short-term treatment to curtail the confusion and rage often associated with dementia, and previous studies have associated these drugs with falls, hip fractures, strokes and death. However, this latest research compiles the potential for death and all other serious risks together for the first time.


Describing their findings as possibly “the tip of the iceberg,” the Canadian research team found that those taking a class of antipsychotic drugs, including generics haloperidol and loxapine, were 3.8 times more likely to be hospitalized or die, while elderly taking newer medicines, including Zyprexa and Risperdal, had 3.2 times more risk of death or complications requiring hospitalization.


“Newer antipsychotic drugs (olanzapine, quetiapine fumarate and risperidone) have been on the market for more than a decade and are commonly used to treat the behavioral and psychological symptoms of dementia,” the authors write as background information in the article. “Antipsychotic drugs are often used for short periods to treat agitation in clinical practice. They are frequently prescribed around the time of nursing home admission.”


About 17% of individuals admitted to nursing homes are given antipsychotic medication within 100 days, and 10% receive only a single prescription. Given the widespread use of short-term prescriptions, it is important to evaluate their safety, the authors note.


Starting in 2005, the US Food and Drug Administration required manufacturers of all five of the newer antipsychotic drugs to include a ``black box' warning of death risk in elderly dementia patients. Use of antipsychotics for dementia patients is “off label,” meaning it is not the condition the drug was originally intended to address.


Dr. Paula A. Rochon, of the Institute for Clinical Evaluative Sciences in Toronto, and colleagues studied older adults with dementia living in the community or in nursing homes between 1997 and 2004. In each setting, the researchers identified three groups of equal size who were identical except for their exposure to antipsychotic medications.


Among 20,682 older adults with dementia living in the community, 6,894 did not receive antipsychotics, 6,894 were prescribed atypical or newer antipsychotics and 6,894 were prescribed conventional antipsychotics, such as haloperidol or loxapine. Among 20,559 older adults with dementia living in nursing homes, 6,853 received no antipsychotics, 6,853 received atypical antipsychotics and 6,853 received conventional antipsychotics.


Participants’ medical records were examined for serious adverse events, defined as hospital admissions and death within 30 days of beginning therapy. “Relative to community-dwelling older adults with dementia who did not receive a prescription for antipsychotic drugs, similar older adults who did receive atypical antipsychotic drugs were three times more likely and those who received a conventional antipsychotic drug were almost four times more likely to experience a serious adverse event within 30 days of starting therapy,” the authors wrote.


They added: “Relative to nursing home residents in the control group, individuals in the conventional antipsychotic therapy group were 2.4 times more likely to experience a serious adverse event leading to an acute care hospital admission or death. Those in the atypical antipsychotic group were 1.9 times more likely to experience a serious adverse event during 30 days of follow-up.”


The authors stressed that their analysis actually may underestimate the number of adverse events because of the short length of follow-up. In addition, physicians who notice early signs of a problem may take patients off antipsychotics, avoiding more serious consequences, and many serious events experienced by nursing home residents are dealt with in the facility without hospital admission.


“Our results exploring serious adverse events likely identify only the ‘tip of the iceberg’,” the Canadian team wrote. “Antipsychotic drugs should be prescribed with caution even for short-term therapy.”

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