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Olanzapine (Zyprexa) should not be prescribed to treat dementia in people over the age of 65 years
Notice type:
Warning
Date:
09/03/2004
Product name or type:
Olanzapine (Zyprexa)
Active Substance:
Olanzapine
Product Classification:
atypical antipsychotics
Target Audience:
Healthcare professionals and patients
Problem Or Issue:
The Irish Medicines Board (IMB) today stated that following its participation in a European review of olanzapine (Zyprexa) it is strongly recommending to healthcare professionals that this medicinal product should not be prescribed to treat dementia in people over the age of 65 years.
The IMB confirmed that data from recent clinical trials show an increased risk of cerebrovascular adverse events (CVAEs) and mortality in elderly patients with dementia who are treated with olanzapine. The IMB states that throughout Europe, olanzapine is not authorised for the treatment of elderly dementia-related psychosis and/or behavioural disturbances and is not recommended for use in this group of patients. The product information has been amended to include appropriate warnings for prescribers as well as for patients.
In addition, relevant groups of physicians have been informed of this new information.
Olanzapine is licenced in Ireland since 1996 and belongs to a group of medicines known as “atypical” antipsychotics. Atypical antipsychotics are medicinal products that are mainly used for the treatment of schizophrenia, but are also authorised for manic disorders, bipolar disorder, severe agitation and disturbed behaviours in patients with schizophrenia. Other medicines in this group include risperidone (Risperdal) and quetiapine (Seroquel).
The IMB commented that it is possible that the increased risk of CVAE is a common effect of all atypical antipsychotic medicines but evidence to support this view is at present limited. Further data is expected and the IMB stated that once this data is reviewed and assessed, regulatory action, if required or deemed appropriate will be taken. Risperidone is licensed at present in Ireland for use in the management of behavioural disorders in patients with dementia. The IMB stated that the risk of CVAE in patients treated with risperidone has been known for some time and its product information includes warning statements reflecting this data.
The IMB advised that additional clinical trial data in elderly patients with dementia has become available which confirms that the increased risk of cerebrovascular events (CVAE) with risperidone is similar to that seen with olanzapine. Assessment of this new data is on-going at present in Ireland and in other Member States. Any further regulatory action considered necessary will be implemented when this review is completed.
The IMB commented that there is insufficient evidence to determine any increased risk associated with use of quetiapine at this time. However, further investigations are ongoing and any regulatory action deemed appropriate will be taken. The IMB urged patients or family members of patients with concerns regarding any of the above medicines not to suddenly discontinue their treatment, but to seek advice from their doctor or consultant. The IMB will continue to monitor this issue as additional data becomes available, implement any regulatory action deemed appropriate and keep healthcare professionals informed.
Background Information Or Related Documents:
Atypical Antipsychotics - Question and Answer Document
Olanzapine (Zyprexa) should not be prescribed to treat dementia in people over the age of 65 years Document
Actions To Be Taken:
The IMB urged patients or family members of patients with concerns regarding any of the above medicines not to suddenly discontinue their treatment, but to seek advice from their doctor or consultant.
Further Information:
Further information, including Question and Answer documents are available from the websites at
www.hpra.ie
and the European Agency for the Evaluation of Medicinal Products (EMEA) at
www.emea.eu.int
FOR INFORMATION:
Siobhan Molloy/Jackie Henderson
Tel: (01) 6760168 Weber Shandwick FCC.
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Date Printed: 08/05/2024