Caustinerf arsenical and Yranicid arsenical
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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
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About this medicine
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| Approved name |
Caustinerf arsenical and Yranicid arsenical
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| International non-proprietary name (INN) or common name |
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| Class |
Dental pulp devitalising
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About this procedure
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| Current status |
European Commission final decision
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| Reference number |
EMEA/H/A-31/1382
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| Type | |
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Key dates and outcomes
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|---|---|
| CHMP opinion date |
25/04/2014
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| EC decision date |
11/07/2014
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All documents
Opinion provided by Committee for Medicinal Products for Human Use
European Commission final decision
Caustinerf arsenical and Yranicid arsenical Article-31 referral - CHMP assessment report (PDF/206.77 KB)
First published: 06/08/2014
Last updated: 06/08/2014
EMA/CHMP/10350/2014
Caustinerf arsenical and Yranicid arsenical Article-31 referral - Annex I (PDF/39.29 KB)
First published: 06/08/2014
Last updated: 06/08/2014
Caustinerf arsenical and Yranicid arsenical Article-31 referral - Annex II (PDF/62.76 KB)
First published: 06/08/2014
Last updated: 06/08/2014
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.