COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE PURSUANT TO ARTICLE 5 OF REGULATION (EC) No 726/2004, ON BISPHOSPHONATES AND OSTEONECROSIS OF THE JAW

OPINION OF THE COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE PURSUANT TO ARTICLE 5(3) OF REGULATION (EC) No 726/2004, ON BISPHOSPHONATES AND OSTEONECROSIS OF THE JAW

Basis for opinion
On 30 January 2009 Denmark (DK) presented to the EMEA a request for a CHMP opinion under Article 5(3) of Regulation (EC) No 726/2004 to review issues related to the adverse event osteonecrosis of the jaw (ONJ) following the use of bisphosphonates.
Specifically, the Committee was requested to draw up an opinion on the suspected association between bisphosphonates and ONJ, including advice on the following issues:
1. The criteria for the diagnosis or definition of ONJ,
2. The underlying pathophysiological mechanism,
3. The risk stratification between products and patient populations,
4. To reach an agreement on appropriate/necessary risk minimisation measures.

On the basis of the request made by Denmark, the CHMP considered that there were sufficient grounds to start the procedure.
The procedure started on 19 February 2009.

Opinion
The CHMP, having considered the matter as set out in the appended assessment report (Appendix 1), reviewed the available evidence and came to the conclusion that
1) The criteria for the diagnosis or definition of ONJ should be as follows:
“A patient may be considered to have ONJ related to bisphosphonates if all of the following 3 characteristics are present:
• Exposed or necrotic bone in the maxillofacial region that has persisted for more than 8 weeks
• No history of irradiation of the jaw
• Current or previous treatment with a bisphosphonate”
The related staging system should be applied.

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