By May 2021, the FAERS database contained a total of 22,002,078 reported cases of ADRs. Our methods include a wide search of the FAERS database for cases of medication induced ONJ with a total number of cases being reviewed at 19,668. The search strategy was that within the FAERS database we specified a “Search by Reaction Term” and looked up “Osteonecrosis of jaw.” We then selected a time frame with the first time period being similar to that of the original study from April 1, 2010 to December 31, 2014 (labeled as “time period 1”) and the second time period being from April 1, 2015 to Jan 12, 2021 (labeled as “time period 2”). Time periods 1 and 2 contained 8,253 and 11,415 cases respectively. We then determined our inclusion criteria for both sets of data. In doing so, we excluded patients that did not have gender listed as part of the patient demographics (ie, gender labeled as “Not specified”). Secondly, we did not include cases for patients below the age of 18, as we were primarily evaluating adult data. Thirdly, since the FAERS database allows consumers, healthcare professionals, and non-specified individuals to report their findings, we only included those reported by healthcare professionals allowing for increased accuracy of reporting. Lastly, we excluded duplicate cases using previously utilized methods, a multistep review process [4 (link)]. This involved identifying common patient characteristics from the FAERS database including patient age, gender, weight, event date, location (by country), drug reactions. After identifying patients with the same common characteristics, it was assumed these were duplicate patient information and thus, the duplicates were removed. This inclusion criteria nearly reduced the number of cases by nearly 60%, resulting in 3,132 cases in time period 1 and 5,776 in time period 2. This breakdown can be seen as a flow chart representation in Fig. 1 . The top 20 medications were identified and described for these two different time periods. An analysis was performed on the collective patient demographics of medication-induced ONJ reports as well as for the two timeline ranges. Specific information obtained for this review included patient age, patient gender, associated medications, and indication for medication use. Descriptive statistics for all categorical [N (%)] variables were determined on all patients’ demographic and clinical characteristics. This project was submitted for review through Advocate Health and was waived as this study was deemed non-human subject related research.![]()
Illustrates a flow chart representation of our inclusion criteria when comparing time period 1 (2010–2014 data set) to time period 2 (2015–2021 data set)
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