Researchers find safety signal between bisphosphonates and nonhealing femoral fractures
An analysis of 15-year data from the FDA Adverse Event Reporting System on bisphosphonate-associated nonhealing femoral fractures has shown that as many as 26% of published cases where delayed or nonhealing occurs.
“To our knowledge, our study is the first to identify a safety signal between bisphosphonates and nonhealing femoral fractures within the [FDA Adverse Event Reporting System] FAERS database,” Beatrice J. Edwards, MD, MPH, and colleagues wrote in their study. “In March 2010, the FDA had stated that it was not able to identify a safety signal involving bisphosphonates and atypical femoral fractures within this database.”
In addition to analyzing the FAERS database, Edwards and colleagues also conducted a systematic review of Pubmed and Embase articles between 1990 and 2012 and found 289 articles with an association between bisphosphonates and nonhealing femoral fractures. The FAERS database yielded 362 cases with a proportional reporting ratio of 4.51 between bisphosphonates and nonhealing femoral fractures; 317 of these cases were associated with the drug alendronate, the researchers found.
The researchers noted these fractures are a rare adverse event to bisphosphonates therapy, however, they said better understanding of the mechanisms of these fractures is needed to develop a prediction model.
Disclosure: This study was funded in part by a grant from the National Institutes of Health.