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  • FDA Date: 11/12/2008

    Actonel (risedronate) FDA Drug Safety Communication

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

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    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