Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group

Current status:
Under evaluation

Overview

EMA review of impurities in sartan medicines

The European Medicines Agency (EMA) is reviewing the blood pressure medicines candesartan, irbesartan, losartan, olmesartan and valsartan in relation to impurities found in some batches of these medicines.

The impurities are N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA). Both NDEA and NDMA belong to the class of nitrosamines and are classified as probable human carcinogens (substances that could cause cancer) based on animal studies.

The review will evaluate the root cause for the presence of these impurities, their possible impact on patients and what measures can be taken to reduce or eliminate these impurities from future batches.

Some medicines covered by this review are no longer available in the EU. Medicines containing valsartan made by Zhejiang Huahai in China have been recalled by national authorities. Medicines containing valsartan from another company Zhejiang Tianyu are no longer being distributed in the EU.

EMA has published preliminary risk estimates for patients who took affected valsartan medicines containing NDMA. Further risk estimates will be made available as the review progresses.

Although the review initially was focused on valsartan medicines, it was expanded as a precautionary measure to include other 'sartan' medicines with a similar chemical structure in September 2018 following the detection of very low levels of NDEA in some batches of losartan.

EMA will provide regular updates on its website.

Key facts

Approved name
Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
International non-proprietary name (INN) or common name

valsartan, candesartan, irbesartan, losartan and olmesartan

Associated names
  • Karvezide
  • Karvea
  • Irbesartan/Hydrochlorothiazide Teva
  • Irbesartan Zentiva (previously Irbesartan Winthrop)
  • Irbesartan Teva
  • Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)
  • Ifirmasta (previously Irbesartan Krka)
  • Ifirmacombi
  • Aprovel
  • Neparvis
  • Exforge
  • Exforge HCT
  • Entresto
  • Dafiro HCT
  • Dafiro
  • Copalia HCT
  • Copalia
  • Amlodipine / Valsartan Mylan
Class
angiotensin-II-receptor antagonist
Reference number
EMEA/H/A-31/1471
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
Under evaluation

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:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

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