COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE PURSUANT TO ARTICLE 5(3) OF REGULATION (EC) No 726/2004, ON CONVENTIONAL ANTIPSYCHOTICS

OPINION OF THE COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE PURSUANT TO ARTICLE 5(3) OF REGULATION (EC) No 726/2004, ON CONVENTIONAL ANTIPSYCHOTICS

Basis for opinion
On 23 October 2008, the United Kingdom presented to the EMEA a request for a CHMP opinion under Article 5(3) of Regulation (EC) No 726/2004 on conventional antipsychotics, as a result of recently available data on the safety of antipsychotic medicines from epidemiological studies and in more detail with regards to the risks of antipsychotics when used in elderly people with dementia.

Specifically, the Committee was requested to provide advice on the following four issues:

(1) the strength of the evidence to suggest that conventional antipsychotics are associated with excess mortality when used in elderly people with dementia;
(2) the strength of the evidence to suggest that conventional antipsychotics are associated with a greater risk of mortality compared with atypical antipsychotics;
(3) whether or not the risk can/should be extrapolated to those conventional antipsychotics not included in the studies;
(4) the need to conduct further studies, including on the possible mechanisms underlying the increase in mortality observed.

On the basis of the request made by United Kingdom, the CHMP considered that there were sufficient grounds to start the procedure.
The procedure started on 23 October 2008.

abrir aquí para acceder al documento EMEA en pdf:
http://www.emea.europa.eu/pdfs/human/opiniongen/Conventional_Antipsychotics_Article5.3-CHMP_Opinion.pdf