Bisphosphonate‐related osteonecrosis of the jaw: data from the French national pharmacovigilance database

Abstract

The aim of this study was to describe bisphosphonate-related osteonecrosis of the jaw (BRONJ) in the French national pharmacovigilance database. BRONJ was identified with the standardized MedDRA query (SMQ) 'osteonecrosis' among all data from 1985 to 31 December 2014. Because this SMQ was not specific to the jaw localization, selection of cases based on anatomy was performed after data extraction. For each case, demographic and medical information was analysed, as well as data about notification (year of notification, year of occurrence, outcome, seriousness). Known associated factors for BRONJ were also documented: dentoalveolar surgery, glucocorticoids, chemotherapy, anti-angiogenics, denosumab. Among 1404 SMQ notifications, 663 were located in the jaws and 629 were associated with bisphosphonate use. BRONJ reported in the database mainly affected women (n = 443, 71%) with an oncological indication (n = 440, 70%). BRONJ was considered as serious in 91%. Outcome was unfavourable for 92% of cases. Associated factors were identified for 70% of the patients. A peak of notification was noted in 2014 (13% of all cases), but on analysis by year of occurrence instead of by year of notification, this peak disappeared. SMQ 'osteonecrosis' appears to be an adequate tool to analyse BRONJ in a pharmacovigilance database.

Use of new targeted cancer therapies in children: effects on dental development and risk of jaw osteonecrosis: a review

“…Studies published in the last 10 years evaluating the adverse effects of bisphosphonates, denosumab, and bevacizumab on dental development and the risk of jaw osteonecrosis were selected. The search resulted in 18 articles (20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(37)(38)(39)(40)(41)(42)(43).…”

“…According to Bamias et al, this complication occurs after 35 perfusions on average, or with a cumulative bisphosphonate dose (Zometa ® Novartis) of 140 mg . The majority of reported BRONJ is associated with zoledronate (70%), alendronate (16%), or pamidronate (11%) .…”

Alcohol, microbiome, life style influence alcohol and non-alcoholic organ damage

“…Thus it is to be expected that there will be an interaction between the gut microbiome and the liver. Bile acids have been shown to facilitate the communication between the intestine and the liver (Dawson and Karpen, 2015). They regulate hepatic glucose, lipid metabolism and inflammation via the farsenoid X receptor (FXR) (Fuchs et al, 2013;Pineda Torra et al, 2003).…”

Osteonecrosis of the Jaw (ONJ) in Osteoporosis Patients: Report of Delayed Diagnosis of a Multisite Case and Commentary about Risks Coming from a Restricted ONJ Definition

“…ONJ case reports and case series in osteoporosis patients have been published worldwide after oral bisphosphonates (alendronate, risedronate, ibandronate), intravenous bisphosphonates (i.e., yearly 5 mg intravenous zoledronic acid, or intravenous ibandronate at 3 mg dose every 3 months), as well as subcutaneous denosumab (at 60 mg dose every 6 months). Even if these are probably a minority of cases actually observed in real life, hundreds of patients were included in large drug surveillance reports, in spite of a generalized poor attitude of physicians and dentists with regard to registering drug side effects [ 19 , 20 , 21 , 22 , 23 , 24 ].…”