Standardized classification unsuitable for spontaneous reporting: the example of osteonecrosis of the jaw

Abstract

Objective: This study assessed the impact of using a standardized definition of bisphosphonate-related osteonecrosis of the jaw (BRONJ) in the analysis of a spontaneous reporting database.

Methods: All notifications of osteonecrosis of the jaw (ONJ) in the French National Pharmacovigilance Database as of 31 December 2013 were analyzed. First, we considered all reports of ONJ with bisphosphonates as BRONJ. Second, we applied the 2014 definition of BRONJ from the American Association of Oral and Maxillofacial Surgeons (AAOMS), retaining only bisphosphonates as antiresorptive medication. In the absence of any one of these criteria, or missing data, cases were not considered as BRONJ.

Results: The first analysis found 158 cases of ONJ, among which 153 were associated with bisphosphonate use. The second analysis identified only 43 cases of BRONJ (28.1%).

Conclusion: The definition of BRONJ as laid down by the AAOMS is not suitable for use in spontaneous reporting database. The use of the AAOMS definition alone should be avoided, as it leads to the exclusion of over 70% of cases. When cases of ONJ are identified, all results should be presented including confirmed and excluded cases.

Keywords:

• adverse drug reaction
• bisphosphonates
• osteonecrosis of the jaw
• spontaneous reporting

Acknowledgments

The authors thank Fiona Ecarnot (EA3920, University Hospital Besancon, France) for translation and editorial assistance. We also thank all team members of the 31 French pharmacovigilance centers as well as the French Drug Safety Agency (ANSM) for the availability of the data.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents, received or pending, or royalties.