FP7 will fund research to test safety of antipsychotics in people with dementia

Wednesday 23 May 2012

The European Commission's Seventh Framework Programme (FP7) will provide funds to research the long-term safety effects of antipsychotics in people with dementia. This decision is based on a recommendation by the European Medicines Agency (EMA).

Antipsychotics are divided into typical and atypical groups. In 2005, it was determined that atypical antipsychotics caused a higher mortality rate among elderly people with dementia. However, it was not known whether this effect also extended to the typical antipsychotics.

The EMA's Committee for Medicinal Products for Human Use (CHMP), which investigated this issue, found some evidence that the risk of increased mortality was higher in typical antipsychotics. However, methodological limitations prevented firm conclusions. The CHMP also concluded that it was not possible to differentiate between different antipsychotics and that further research was needed. This led directly to EMA's recommendation to the Commission.

The objective of the research will be to investigate and quantify the increased risk of mortality in elderly people with dementia treated with antipsychotic drugs and to explore risk factors and the underlying mechanism(s) for any observed increased risk. Variables to be studied include dose, renal impairment, body weight, treatment combinations and co-medication. The research should generate data that will allow the comparison of different antipsychotic drugs with regard to their risk of serious cardiac and cardiovascular events and mortality in elderly people with dementia.

www.ema.europa.eu/docs/en_GB/document_library/Other/2012/05/WC500127477.pdf