A class of drugs widely prescribed for people suffering from dementia is leading to the premature deaths of thousands of patients every year, according to research published today. Campaigners branded the continued use of the sedatives, called neuroleptics, a national scandal after a five-year study revealed that people with Alzheimer's disease and other forms of dementia are twice as likely to die if they are prescribed them.
Neuroleptics are widely prescribed to help control symptoms of Alzheimer's and dementia including agitation, hallucinations and erratic behaviour, despite only being licensed for use in people suffering from schizophrenia. The research suggests they are of little benefit to patients with milder symptoms, greatly increase their risk of dying prematurely, and that 45% of Alzheimer's patients in care homes are prescribed a neuroleptic drug.
A group of 165 Alzheimer's patients were randomly assigned to take one of three types of neuroleptic drugs, or a placebo. After two years 45% of those who took the real drugs had died compared with 22% who were given the placebo.
The King's College London researchers who undertook the project, funded by the Alzheimer's Research Trust, found that after three years 65% of those on the drugs had died compared with 38% of those on placebos. After 42 months 75% of those on the drugs had died compared with 60% on the placebo. On average patients who were on the drugs died six months earlier.
Clive Ballard, professor of age-related disorders at King's and the lead researcher, said that not only were people more likely to die but they also suffered severe side-effects including stroke, chest infections and falls.
"If this was a massive increase in mortality in children there would be an outcry. Older people aren't seen as a priority. These sedatives are being used because the services can't cope with people who are in a distressed state. There are ways to avoid them but it would involve training of staff, which is costly."
In 2004 the medicines watchdog issued a warning that two types of neuroleptics, olanzapine and risperidone, should not be given to Alzheimer's patients because of an increased risk of stroke and death.
Despite this, in 2005 the Alzheimer's Society presented evidence that 100,000 people suffering from dementia were being prescribed a neuroleptic drug.
Neil Hunt, chief executive of the society, said: "Neuroleptics have been used as a dangerous fix for 'challenging behaviour' in people with dementia for too long. They are not licensed for use among people with dementia, but continue to be hugely over-prescribed. It is a national scandal that people are being sedated in this way ... These drugs must be a last resort, only used when all other methods have failed to alleviate the most distressing symptoms of dementia."
Rebecca Wood, chief executive of the Alzheimer's Research Trust, said: "These results are deeply troubling and highlight the urgent need to develop better treatments."
The Medicines and Healthcare products Regulatory Agency (MHRA), which is responsible for the safety of medications, said neuroleptics were not licensed for use to treat dementia. "The MHRA continues to monitor the unlicensed use of neuroleptics in the treatment of patients with Alzheimer's disease and will carefully review this new study to see what further action may be necessary."
Professor Mayur Lakhani, chairman of the Royal College of General Practitioners, said: "We would like to reassure patients, relatives and carers that neuroleptic drugs are not routinely prescribed to patients with dementia, and are used only as a last resort when patients suffer from severe episodes."