Bisphosphonates: atrial fibrillation

Clinical trial results suggest an increased risk of atrial fibrillation for zoledronic acid (Aclasta▼), pamidronic acid, and possibly for alendronic acid, although the balance-risk remains favourable for bisphosphonates.

From:
Medicines and Healthcare products Regulatory Agency
Published
11 December 2014
Therapeutic area:
Cancer, Endocrinology, diabetology and metabolism, Obstetrics, gynaecology and fertility, Rheumatology

Article date: July 2008

Bisphosphonates are used for:

  • prophylaxis and treatment of osteoporosis
  • treatment of Paget’s disease
  • as part of some anticancer regimens

A clinical trial found an increased incidence of atrial fibrillation in women treated with once-yearly zoledronic acid (Aclasta▼). [footnote 1] Furthermore, a review of the fracture intervention trial for alendronic acid showed a non-significant trend toward an increased risk of atrial fibrillation in patients treated with alendronic acid. [footnote 2]

These concerns have led to a Europe-wide review of bisphosphonates and atrial fibrillation, including review of clinical-trial data, spontaneous reports of suspected adverse drug reactions, and published literature. This review included 2 recently published observational studies on alendronic acid and the risk of atrial fibrillation, which had conflicting results.[footnote 3] [footnote 4] The conclusions of the review are given below.

Information for healthcare professionals

The risk of atrial fibrillation in association with bisphosphonate treatment seems to be low, and the balance of risks and benefits for bisphosphonates remains favourable.

To date, clinical trial results have suggested an increased risk of atrial fibrillation for zoledronic acid (Aclasta▼), pamidronic acid, and possibly for alendronic acid.

The product information for zoledronic acid has been updated to include atrial fibrillation as a possible side-effect (both for Aclasta▼ and Zometa, a product that contains zoledronic acid that is given every 3–4 weeks as part of cancer treatment). Atrial fibrillation is also being added to the product information for pamidronic acid.

The risk of atrial fibrillation with alendronic acid will be kept under close review. Should further evidence accumulate, the product information for alendronic acid will be updated accordingly.

Article citation: Drug Safety Update Jul 2008; Vol 1, Issue 12: 4

  1. Black DM, et al. N Engl J Med 2007; 356: 1809–22. ↩

  2. Cummings SR, et al. N Engl J Med 2007; 356: 1895–96. ↩

  3. Sørensen HT, et al. BMJ 2008; 336: 813–16. ↩

  4. Heckbert AR, et al. Arch Intern Med 2008; 168: 826–31. ↩

Updates to this page

Published 11 December 2014
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