May 27 2008
A Canadian study has found that prescribing antipsychotic drugs for elderly people may be dangerous.
Antipsychotic therapy is widely used to manage behavioural problems such as aggression which is sometimes associated with dementia; they are often prescribed prior to admission to a nursing home.
They are commonly used to treat psychosis with conditions such as schizophrenia, bipolar disorder, mania and delusional disorder.
The researchers from the Institute for Clinical Evaluative Sciences (ICES) in Ontario say elderly patients who are given antipsychotic drugs are at an increased risk of having an event that is serious enough to lead to hospitalization or death within a month of starting the therapy.
In a study which looked at all Ontario residents aged 66 years and older diagnosed with dementia, 20,682 older adults with dementia living in the community were compared with another 20,559 individuals living in nursing homes.
In a period stretching from April 1, 1997 to March 31, 2004 the researchers looked at the risk of developing serious events that led to hospitalization or death within 30 days of starting the therapy.
Lead author Dr. Paula Rochon, says it is a double edged sword because while the drug may make life easier in some very difficult situations, it may cause serious harm to the frail elderly and on the other.
Dr. Rochon says caution is needed even when short term therapy is being prescribed, to ensure that the benefits of the drug outweigh the risks for the individual.
The research revealed that 5.2 percent of the nursing homes residents died within a month of being given one of the newer class of antipsychotic drugs, compared to 3.3 percent of residents who did not take the drugs who died within a month.
Among community-dwelling patients, nearly 14 percent taking the drugs suffered a "serious health event" within 30 days, compared to about 4 percent not on the drugs.
The researchers say the study demonstrates the importance of the post-marketing surveillance of new drugs as clinical trials often fail to detect problems that occur when such drugs are used in wider community by frail individuals.
Dr. Rochon says regulatory bodies need to consider their findings in future with regard to deciding the future of such drugs and suggests the research has merely revealed "the tip of the iceburg".
Antipsychotics first came into use in the 1950s - most of the drugs in the second generation, known as atypical antipsychotics, have more recently been developed and have commonly been in use with Alzheimer patients.
The FDA has now ordered the manufacturers of these newer antipsychotic medications which include Risperdal, Zyprexa and Seroquel, to add a new warning to already existing black-box warnings that the drugs are associated with an increased risk of death related to psychosis and behavioural problems in elderly patients with dementia.
The study also found that the older antipsychotic drugs such as Haldol, posed even higher risks, as much as four times the risk, of serious health problems or death.
The study was funded by the Canadian Institutes for Health Research.
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