FDA reviews bisphosphonate safety

The FDA has reviewed clinical trial data examining the risk of atrial fibrillation associated with bisphosphonate use. One large study of zoledronic acid showed a significant increase in the rate of serious atrial fibrillation events but across all studies reviewed no clear association between overall bisphosphonate exposure and the rate of atrial fibrillation was observed. Based on the current data, the FDA recommends clinicians continue to prescribe bisphosphonates.

The seven FDA-approved bisphosphonates include: alendronate (Fosamax and Fosamax Plus D, from Merck), etidronate (Didronel, from Procter & Gamble), ibandronate (Boniva, from Roche), pamidronate (Aredia, from Novartis), risedronate (Actonel and Actonel w/calcium, from Procter & Gamble), tiludronate (Skelid, from sanofi-aventis) and zoledronic acid (Reclast and Zometa, from Novartis).

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm079352.htm.