title: 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%).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Reims University Hospital, Department of Pharmacovigilance and Pharmacoepidemiology , Avenue du General Koenig, 51100 REIMS , France + 33 3 26 78 77 80 ; + 33 3 26 83 23 79 ; ttrenque@chu-reims.fr.
authors.forename: Paul
authors.initials: P
authors.lastname: de Boissieu
authors.forename: Thierry
authors.initials: T
authors.lastname: Trenque
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D059266:Bisphosphonate-Associated Osteonecrosis of the Jaw / Q000175:diagnosis*; D050071:Bone Density Conservation Agents / Q000494:pharmacology; D004164:Diphosphonates / Q000494:pharmacology*; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D060735:Pharmacovigilance; D012015:Reference Standards; D058028:Research Report / Q000592:standards*; D012720:Severity of Illness Index
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates
keywords: adverse drug reaction; bisphosphonates; osteonecrosis of the jaw; spontaneous reporting