The CHMP has concluded the benefits of four fibrates continue to outweigh their risks in the treatment of blood lipid disorders, following a review.
The Committee says bezafibrate, ciprofibrate, fenofibrate and gemfibrozil should only be used as second-line treatments, except for patients with severe hypertriglyceridaemia or who cannot take statins.
Fibrates have been in use for many years to lower level of lipids and were first reviewed in 2005 by the CHMP’s Pharmacovigilance Working Party.
The current review was initiated at the request of the UK after a number of marketing authorisation holders of the four fibrates questioned the conclusions of the Party and whether existing authorisations should be changed.
The CHMP decided against any changes, however it did note additional new data on fenofibrate and recommended its use together with a statin in some circumstances when a statin alone has not been enough to control blood lipid levels.
The recommendation has now been sent to the European Commission for the adoption of a binding decision throughout the European Union.