NEW ADVICE ISSUED ON RISPERIDONE AND OLANZAPINE
9 Mar 2004 11:15 AM
New expert advice issued today recommends that two atypical
antipsychotic drugs, risperidone and olanzapine, should not be used
to treat behavioural problems in older patients with dementia.
The Committee for the Safety of Medicines (CSM) has reviewed the data
for risperidone and olanzapine. The evidence showed that there is a
three-fold increase in the risk of stroke for risperidone when used
in older patients with dementia. It showed there was a similar risk
with olanzapine.
Antipsychotics are licensed to treat acute psychosis and
schizophrenia. However, they are also prescribed off label to treat
behavioural problems in older people with dementia and clinical
trials show some evidence of benefit to patients. Last year,
approximately 30,000 patients aged 65 and over were receiving
risperidone and 9,000 were receiving olanzapine for the treatment of
dementia.
The Chairman of the CSM, Professor Gordon Duff, said:
"Atypical antipsychotic drugs are an effective way of managing a
range of conditions and have a good safety record. The advice issued
today relates only to two specific atypical anti-psychotic drugs
being used to treat behavioural symptoms for dementia. Other patients
using this type of drug to manage other conditions are not affected.
Treatment should only be stopped on the advice of a doctor. Where
elderly patients with dementia are receiving one of these drugs,
carers should arrange for the doctor to review treatment as soon as
practical within the next few weeks".
Sir Alasdair Breckenbridge, Chair of MHRA, said:
"Antipsychotics are not licensed for the treatment of behavioural
problems in dementia but we know they are used in these patients
outside their licensed indications where prescribers make a judgement
on their own responsibility that it is the right treatment for a
particular patient. Many patients who suffer from dementia can be
managed without medicines and for those who do need drug treatment,
there are a variety of alternatives available".
The MHRA and the Department for Health are developing new guidelines
with the Royal College of Psychiatrists, Alzheimer's Society and
National Care Standards Commission on alternative ways of managing
this condition.
Prescribing information has been cascaded via message to healthcare
professionals through the Chief Medical Officers Public Health Link;
advice to prescribers and patients is also available on the MHRA
website.
Notes to Editors
1. The CSM is an independent Committee of scientific experts that
advise Government on the safety, quality and effectiveness of
medicines, including vaccines. It is also responsible for promoting
the collection and investigation of reports on suspected adverse
reactions to medicines already on the market. The MHRA is the
executive arm of the UK's Drug Licensing Authority and is responsible
for all aspects of the regulation of medicines in the UK.
2. Atypical antipsychotic drugs are a group of medicines used to
treat conditions such as schizophrenia, agitation, anxiety, mania and
aggression. They are 'atypical' because they are less likely than
standard antipsychotic drugs to cause movement disorders as a
side-effect (these may resemble Parkinson's Disease).
3. Dementia is a name for a group of degenerative diseases which
cause profound memory loss, particularly in the elderly. Alzheimer's
disease is the commonest form of dementia.
4. CSM issued advice in 2000 in relation to the risk of adverse
effects of Melleril for those with a history of cardiac problems.