Fracture‐Centred Skeletal Reporting Profiles of Glucose‐Lowering Drug Classes in FAERS and JADER : Cross‐Database and Regional Reporting‐Context Analyses
Authors' conclusion
Skeletal reporting profiles varied by drug class, database, and reporting context. Apparent total-Asian elevations for several classes were predominantly Japan-driven and should not be interpreted as patient-level Asian fracture risk.
Study context
- Population
- FAERS and JADER adverse-event reports for nine glucose-lowering drug classes15,473,015 FAERS, 1,037,161 JADER reports
- Exposure
- Nine glucose-lowering drug classes; Western vs Japan vs non-Japan Asia
- Outcome
- Fracture, as reporting frequency per 10 000 mapped suspect reports
Methodological detailscross-database, regional reporting-context analyses, disproportionality analyses supplementary
- Cross-database
- Regional reporting-context analyses
- Disproportionality analyses supplementary
Main finding
As reported in the abstract
Fracture reporting frequency per 10 000 suspect reports
| Group | Value | Database |
|---|---|---|
| Insulin | 126.08/10000 | FAERS |
| DPP-4i | 111.03 | FAERS |
| SU | 103.76 | FAERS |
| TZD | 152.54 | JADER |
| SGLT2i | 115.14 | JADER |
| GLP-1 RA | 112.15 | JADER |
Value
Insulin126.08/10000
DPP-4i111.03
SU103.76
TZD152.54
SGLT2i115.14
GLP-1 RA112.15
Database
InsulinFAERS
DPP-4iFAERS
SUFAERS
TZDJADER
SGLT2iJADER
GLP-1 RAJADER
- Fracture reports: FAERS / JADER
- 202 881 / 10 678
Observational data: associations, not effects.
Further findings
| Outcome | RFR (95% CI) |
|---|---|
| Regional reporting context (Japan vs non-Japan Asia)After excluding Japan · adjusted for age, sex, calendar year, and reporter type | 1.96 (1.57–2.45) |
- Regional reporting context (Japan vs non-Japan Asia) — Japan share of total-Asian fractures for TZD, GLP-1 RA, SGLT2i and DPP-4i
- 83.0%-92.9%
Regional reporting context (Japan vs non-Japan Asia)
- Corresponding non-Japan Asian RFRs not clearly elevated
Age-threshold sensitivity analyses
- Age unavailable in unique FAERS suspect reports
- 44.9%
- Findings stable across age thresholds (≥60, ≥65, ≥70 years)
Fracture disproportionality
- No class met FDR-positive fracture disproportionality criteria
Original publication
Fracture‐Centred Skeletal Reporting Profiles of Glucose‐Lowering Drug Classes in FAERS and JADER : Cross‐Database and Regional Reporting‐Context Analyses. Diabetes Obes Metab. Published 14 September 2026. doi:10.
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