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Vol 272 No 7290 p307
13 March 2004

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CSM: Atypical antipsychotic drugs and stroke (more)


Do not use risperidone or olanzapine to treat behavioural problems associated with dementia

Prescribing advice

· Patients with dementia currently treated with an atypical antipsychotic drug should have their treatment reviewed

· Risperidone and olanzapine should not be used for the treatment of behavioural symptoms associated with dementia

· Risperidone should only be used short-term and under specialist advice for acute psychotic conditions in elderly patients with dementia

· Risk of cerebrovascular events should be considered in any patients with previous history of stroke, transient ischaemic attack and other risk factors

The MHRA and the Department of Health are developing new guidelines with the Royal College of Psychiatrists, Alzheimer’s Society and National Care Standards Commission on alternative ways of managing behavioural problems in dementia.

Risperidone (Risperdal) and olanzapine (Zyprexa) should not be used to treat behavioural problems in older people with dementia, recommends the Committee on Safety of Medicines. However, the new advice is likely to cause problems for health professionals managing this group of patients, a mental health pharmacist has warned.

The CSM guidance comes after a review of safety data revealed a three-fold increase in stroke risk for older people with dementia who were treated with risperidone or olanzapine. The Department of health estimates that if six patients are treated with risperidone for one year, one cerebrovascular adverse event would be attributable to the drug.

Atypical antipsychotics are not licensed for treatment of behavioural problems associated with dementia but are used widely in this patient population.

Approximately 30,000 patients aged 65 years and over were treated with risperidone for behavioural problems associated with dementia last year. A further 9,000 received olanzapine for this indication.

The CSM believes many patients who suffer from dementia can be managed without medicines. “For those who do need drug treatment, there are a variety of alternatives available,” said Sir Alasdair Breckenbridge, chairman of the Medicines and Healthcare products Regulatory Agency.

Stephen Bazire, director of pharmacy services, Norfolk Mental Health Care NHS Trust, warned that problems could arise because of the advice. “We have been using low-dose risperidone — 0.25mg to 2mg daily — without apparent problems,” he said. Many people currently managed with low doses of these drugs in nursing homes will have to be cared for in other establishments, he added. The advice would mean reverting to older drugs, such as the phenothiazines and haloperidol, which were not without their own problems.

Mr Bazire suggested pericyazine (Neu-lactil) could be used as an alternative treatment for behavioural problems associated with dementia. However, the dearth of information published on QT prolongation for phenothiazines (other than thioridazine) means that it is difficult to assess their safety. He added that the anticholinergic effects of these drugs would not be helpful in patients already suffering with impaired cognitive function. Use of other atypical antipsychotics without a proven stroke problem would also be an option. Newer dementia drugs, such as the anticholinesterases and memantine, would not be appropriate since they are not effective for calming patients down, he added.

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