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FDA: No Heart Rhythm Risk From Bone Drugs
Nov. 12, 2008 -- The FDA says it sees no proof that the bone drugs called bisphosphonates are linked to a heart rhythm problem called atrial fibrillation.
Bisphosphonates are widely used to treat osteoporosis and to slow bone turnover in patients with Paget's disease of the bone and to treat some cancer patients.
Doctors shouldn't alter their prescribing patterns for bisphosphonates and patients should keep taking their bisphosphonates, according to the FDA.
There are seven FDA-approved bisphosphonates:
- alendronate (sold generically and as Fosamax)
- ibandronate (sold as Boniva)
- risedronate (sold as Actonel)
- zoledronic acid (sold as Reclast and Zometa)
- etidronate (sold as Didronel)
- pamidronate (sold generically and as Aredia)
- tiludronate (sold as Skelid)
The FDA has been looking into a possible association between bisphosphonates and an irregular heart rhythm (atrial fibrillation) since October 2007.
The FDA today stated that, based on the evidence it has reviewed thus far, there is "no clear association between overall bisphosphonate exposure and the rate of serious or nonserious atrial fibrillation."
That finding is based on data from studies of more than 19,000 patients who took bisphosphonates and more than 18,000 other patients who took placebos for up to three years. Atrial fibrillation was "rare within each study, with most studies containing two or fewer events," the FDA states.
The FDA acknowledges mixed results in other studies of atrial fibrillation in patients taking bisphosphonates, and the FDA hasn't ruled out further studies. The FDA will also keep monitoring reports of atrial fibrillation in patients taking bisphosphonates.
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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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