Fibrates

Current status:
European Commission final decision

Overview

The European Medicines Agency has completed a review of the safety and effectiveness of fibrates. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of fibrates continue to outweigh their risks but that they should not be used as 'first line' in the treatment of blood lipid (fat) disorders, such as high cholesterol, except in rare cases. This means that newly diagnosed patients with blood lipid disorders should not be treated using these medicines in the first instance, unless they have very high levels of triglycerides (a type of fat). However, fibrates can be used in patients who cannot take statins (another type of medicine used to lower blood lipid levels).

Key facts

Approved name
Fibrates
International non-proprietary name (INN) or common name
bezafibrate, ciprofibrate, fenofibrate, gemfibrozil
Associated names
  • Bezalip
  • Lipanor
  • Lipanthyl
  • Lopid
Class
fibrates
Reference number
EMEA/H/A-31/001238
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Status
European Commission final decision
Opinion date
21/10/2010
EC decision date
28/02/2011

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

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