On October 1, 2007, FDA announced that it was reviewing safety data that raised concerns about a potential increased risk for atrial fibrillation in patients treated with a bisphosphonate drug (http://www.fda.gov/cder/drug/early_comm/bisphosphonates.htm). An article and an accompanying letter to the editor in the May 3, 2007, issue of The New England Journal of Medicine described increased rates of serious atrial fibrillation in two different studies of women ages 65 to 89 years old with osteoporosis treated with the bisphosphonates, Reclast and Fosamax. Data available to FDA at that time, including data from the NDA approval of Reclast for osteoporosis, showed an increased risk of serious atrial fibrillation and this risk was reflected in the Reclast labeling. After our review, based on the data available at this time, healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication.
