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Osteoporosis Drugs: Risk to the Heart?
April 28, 2008 -- The osteoporosis drug Fosamax may be linked to increased risk of abnormal heart rhythms, a new study shows. But experts urge patients not to quit Fosamax or similar osteoporosis drugs based on the findings.
"We're not saying that this drug should be stopped and we certainly do not feel that patients should stop taking the drug," researcher Susan Heckbert, MD, PhD, tells WebMD. "But we did detect this adverse effect."
The FDA has been probing possible ties between bisphosphonate drugs, which include alendronate (sold generically and as Fosamax), and an irregular heart rhythm ( atrial fibrillation) since last fall, with no firm conclusions yet. So what's an osteoporosis patient to do?
"The benefits of fracture prevention will generally outweigh the risk of atrial fibrillation" in patients at high risk of bone fracture who are already taking a bisphosphonate drug, says Heckbert, who works for the University of Washington's cardiovascular health research unit and epidemiology department.
"What physicians and patients need to do is to weigh the risks and benefits," Heckbert says. "The information is never perfect for patients or physicians. ... They can't find out exactly what the risk is for that individual patient, so they have to do the best job they can with the available information. And this is just additional information about a risk that appears to be present for alendronate."
Atrial Fibrillation Study
Heckbert's study, published in the Archives of Internal Medicine, included 719 women with confirmed atrial fibrillation and 966 women without atrial fibrillation. All of the women were members of the same health care system in Washington.
The researchers checked the women's medical records and found that 6.5% of the atrial fibrillation patients and about 4% of women without atrial fibrillation had taken Fosamax.
Compared with women who had never used any bisphosphonate drug, women who had ever taken Fosamax were 86% more likely to have atrial fibrillation.
Still, Fosamax wasn't a major risk factor for atrial fibrillation. "In this population of women, the proportion of atrial fibrillation cases that could have been explained by alendronate use was only 3%," Heckbert says.
The study doesn't prove that Fosamax caused atrial fibrillation. The study was observational, meaning that patients weren't randomly assigned to take Fosamax.
The results held when the researchers weighed other heart rhythm risk factors. "It was a robust finding," says Heckbert, cautioning that observational studies can't address every possible influence on the data.
Heckbert and colleagues did the study after other researchers last year reported an increased rate of atrial fibrillation associated with the osteoporosis drug Reclast, which, like Fosamax, is a bisphosphonate.
But in another recent study, Danish researchers found no evidence of increased risk of atrial fibrillation in women taking bisphosphonates.
"Medicine is like that," Heckbert says. "We don't always find the same things."
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VIVELLE-DOT (estradiol transdermal system) IS AVAILABLE BY PRESCRPTION ONLY.
INDICATION
Vivelle-Dot is used after menopause to: reduce moderate to severe hot flashes; treat moderate to severe dryness, itching and burning in or around the vagina; help reduce your chances of getting osteoporosis (thin weak bones); and treat certain conditions in which a young woman's ovaries do not produce enough estrogens naturally. Vivelle-Dot 0.025 mg/day is only used to prevent osteoporosis from menopause. If you use Vivelle-Dot only to treat your dryness, itching, and burning in and around your vagina or if you use Vivelle-Dot only to prevent osteoporosis from menopause, talk with your healthcare professional about whether a different treatment or medicine without estrogens might be better for you.
IMPORTANT SAFETY INFORMATION
Estrogens increase the chances of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia (decline in memory and thinking skills).
Vivelle-Dot should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past (for example, in the past year); currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.
The most common side effects that may occur with Vivelle-Dot are headache, breast tenderness, and back pain.
You and your healthcare professional should talk regularly about whether you still need treatment with Vivelle-Dot.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information for Vivelle-Dot.
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