Caustinerf arsenical and Yranicid arsenical

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

Authorisations of Caustinerf arsenical and Yranicid arsenical used in dental procedures revoked in the European Union

On 25 April 2014, the European Medicines Agency recommended that the marketing authorisations for the dental pastes Caustinerf arsenical, Yranicid arsenical and associated names be revoked in the EU due to concerns over the risk of genotoxic effects (damage to the genetic material in cells) and cell death in tissues around the teeth. The dental pastes, which contain an arsenic-based compound, arsenic trioxide, have been used to remove the damaged nerves in the dental pulp (the inside of the tooth).

In a review conducted by the Agency's Committee for Medicinal Products for Human Use (CHMP), analyses of data from laboratory and population studies indicate that the arsenic contained in them may pose a risk of genotoxic effects that could increase the risk of cancer. In addition, there have been a small number of cases where arsenic is thought to have leaked into the areas around the teeth, causing parts of the tissue to die, including bone (osteonecrosis).

During the review, the CHMP considered measures to minimise the risks identified with these products but concluded that restrictions and additional guidance to dentists would not reduce the risks to an acceptable level.

Therefore, in the light of current standard of care available, the Committee concluded that the benefits of Caustinerf arsenical and Yranicid arsenical do not outweigh their risks and recommended that their marketing authorisations be revoked.

The review was initiated at the request of the French medicines agency (ANSM) after new data became available that raised concerns about the safety of these products.

The CHMP recommendation was sent to the European Commission and on 11 July 2014 the Commission issued a legally binding decision revoking the authorisations for Caustinerf arsenical, Yranicid arsenical and associated names throughout the EU.

Key facts

Approved name
Caustinerf arsenical and Yranicid arsenical
International non-proprietary name (INN) or common name
ephedrine hydrochloride, lidocaine and arsenous anhydride
Class
Dental pulp devitalising
Reference number
EMEA/H/A-31/1382
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
25/04/2014
EC decision date
11/07/2014

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:

How useful was this page?

Add your rating