FDA Drug Safety Communication

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FDA Date: 11/11/08

Boniva (ibandronate) Injection FDA Drug Safety Communication

Update of Safety Review Follow-up to the October 1, 2007 Early Communication about the Ongoing Safety Review of Bisphosphonates

FDA reviewed safety data that raised concerns about a potential increased risk for atrial fibrillation (AF) in patients treated with a bisphosphonate drug. Based on data available at this time, healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication. FDA is aware of discordant results from the literature and from other epidemiological studies about the incidence and clinical course of AF in patients taking bisphosphonates. FDA is exploring the feasibility of conducting additional epidemiologic studies to examine this issue. In addition, FDA is continuing to monitor postmarket reports of AF in patients who have taken bisphosphonates.

Examples of bisphosphonates include: alendronate (Fosamax, Fosamax Plus D), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel, Actonel W/Calcium), tiludronate (Skelid), and zoledronic acid (Reclast, Zometa).

View the full FDA Drug Safety Communication on FDA.gov