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
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
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
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.”
article was published in The Osteoporosis Report, Fall 2008.
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