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Should I be concerned about articles that say some osteoporosis medications can cause an irregular heartbeat?

 

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A.

Two studies on alendronate (brand name Fosamax®) suggested a connection between alendronate and atrial fibrillation (1, 2). (Atrial fibrillation is a serious type of irregular heartbeat.) However, a number of other studies did not find a connection. These include a much larger Danish study (3) and other major research studies done in the past on many more thousands of women.

In 2007, the results of a major research study (4) suggested an increased possibility of atrial fibrillation in a small number of postmenopausal women given zoledronic acid (brand name Reclast®). The study’s findings were not conclusive and after reviewing the research results, the Food and Drug Administration (FDA) approved zoledronic acid to treat osteoporosis in postmenopausal women. A second study (5) of this same medicine in older people with more medical problems did not show any increase in atrial fibrillation.

Atrial fibrillation is more commonly found in people 65 years and older, which is the age range of many women in these studies. Both alendronate and zoledronic acid are in a class of drugs called bisphosphonates. To-date, the FDA has approved four bisphosphonate medications to treat osteoporosis.

Due to concerns about atrial fibrillation, the FDA began a safety review of bisphosphonates in 2007. Until more information becomes available, the FDA says there is no need to stop using bisphosphonates. Based on what is currently known, most experts agree that the benefits of taking these medications for osteoporosis outweigh the possible risk of atrial fibrillation.

NOF encourages you to discuss concerns about possible side effects from a medication with your healthcare provider. Let your healthcare provider know if you have any heart problems or other health conditions. People taking an osteoporosis medication should review and discuss their treatment plan each year with their healthcare provider.

Always report any possible medication side effects to your healthcare provider and the FDA. The toll free number for the FDA is (800) 332-1088. To complete a report online, the FDA Web site is www.fda.gov/medwatch/report.htm.

For additional information about the FDA’s ongoing safety review of bisphosphonates, visit the FDA Web site at www.fda.gov/Cder/Drug/early_comm/bisphosphonates.htm

Studies Mentioned Above:

1. In a letter to the editor, a review of the FIT study results was published in the New England Journal of Medicine, May 3, 2007. The name of the article is “Alendronate and Atrial Fibrillation.”

2. This study was published in the Archives of Internal Medicine, April 28, 2008. The name of the article is “Use of Alendronate and Risk of Incident Atrial Fibrillation in Women.”

3. This study was published in the British Medical Journal, April 12, 2008. The name of the article is “Use of Bisphosphonates Among Women and Risk of Atrial Fibrillation and Flutter: Population Based Case-Control Study.” It is available for free at www.bmj.com.

4. The HORIZON study was published in the New England Journal of Medicine, May 3, 2007. The name of the article is “Once-Yearly Zoledronic Acid for Treatment of Postmenopausal Osteoporosis.” It is available for free at www.nejm.com.

5. The HORIZON Recurrent Fracture Trial was published in the New England Journal of Medicine, November 1, 2007. The name of the article is “Zoledronic Acid and Clinical Fractures and Mortality after Hip Fracture.”

Note: This article was published in The Osteoporosis Report, Fall 2008.

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