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Bisphosphonate use is associated with nonhealing femoral fractures



DOI:10.1038/bonekey.2013.90

Data from the USA reveal that bisphosphonate (BP) therapy reduces the rate of hip fractures by 30%, but atypical femoral fractures have been observed in patients taking BPs. In this study, Edwards et al. reviewed data from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) between 1996 and 2011 to ascertain whether a safety signal could be detected linking BP use with nonhealing femoral fractures, which, the authors argue, could represent atypical femoral fractures.

Although the FDA itself had previously reported not being able to detect such a signal, the researchers here reported a definite association between BP therapy and nonhealing femoral fractures. A total of 362 cases were identified in the FAERS database; the proportional reporting ratio (PRR) for BP use and nonhealing femoral fractures was 4.51 (95% confidence interval [CI] 3.44–5.92). Most cases (317) were associated with alendronate use and the PRR for alendronate was 3.32 (95% CI 2.72–4.17).

Editor’s comment: This meta-analysis and study of the FDA FAERS database concludes that atypical femoral fractures are associated with BP use. This is evident on the basis of several criteria and suggests that causality is likely. Although the benefits of BPs are 100-fold greater than the risk of atypical femoral fractures based on current evidence, adverse event reporting may impact negatively on BP treatment, reducing its benefits worldwide.


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