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FDA: Atrial fibrillation events rare in patients taking oral bisphosphonates
Health care professionals should not change prescribing patterns and patients should not stop taking bisphosphonates.
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The FDA has issued an update to its safety review on the potential risk for serious atrial fibrillation in patients taking oral bisphosphonates.
The agency reported that atrial fibrillation among bisphosphonate users is rare and that no clear association was observed in a safety review of 19,687 patients treated with bisphosphonates and 18,358 patients treated with placebo. All patients were followed for six months to three years. Most studies contained two or fewer events. Additionally, the review revealed no increase in rate of atrial fibrillation with increasing dose or duration of bisphosphonate use.
In October 2007, the FDA announced its Early Communication safety review of the potential association between serious atrial fibrillation and bisphosphonates after it was reported in postmenopausal women with osteoporosis taking alendronate (Fosamax, Merck) and zoledronic acid (Reclast, Novartis) in two studies, including HORIZON (N Engl J Med. 2007;356:1809-1822).
Other FDA-approved bisphosphonates include etidronate, ibandronate (Boniva, Roche), pamidronate, risedronate and tiludronate (Skelid, Sanofi Aventis).
The FDA will continue to monitor postmarketing reports of atrial fibrillation in patients who have taken bisphosphonates. The FDA urges health care professionals to report adverse events to the MedWatch Adverse Event Reporting program. – by Katie Kalvaitis
The FDA analysis strongly supports the lack of an association between the bisphosphonates used for osteoporosis and an increased risk for atrial fibrillation. Therefore, as has appeared to be the case, the significant increase in a subset of atrial fibrillation cases in the zoledronic acid HORIZON trial appears to be a chance association and not actually caused by the drug. However, as is always the case, additional information will come out as more time and data come in. But certainly the data we have right now suggest that there is no association between bisphosphonates and either atrial fibrillation or any other cardiac dysrhythmias.
– David B. Karpf, MD
Adjunct Clinical Associate Professor of Endocrinology,
Stanford University School of Medicine
Head, Osteoporosis & Metabolic
Bone Disease Clinic, Stanford University Hospital & Clinics
In recent years, the safety of bisphosphonate therapy has been questioned with respect to the occurrence of atrial fibrillation, osteonecrosis of the jaw and atypical fractures of the femur in patients treated with both intravenous and oral formulations of these drugs. Newspaper reports and Internet postings have produced great concern for many of the patients receiving bisphosphonates. This FDA update indicating that atrial fibrillation is not only a rare event, but does not occur more frequently in bisphosphonate-treated patients than in placebo-treated patients hopefully should reduce the anxiety of patients and their physicians regarding this adverse event. I look forward to future updates on the other suspected complications, since adequate controlled observations are also lacking to indicate the drugs are responsible for these highly unusual problems.
– Frederick Singer, MD
Director, Endocrine/Bone Disease Program
John Wayne
Cancer Institute