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Once-a-Month Osteoporosis Drug Approved
March 28, 2005 - A new drug allows people to protect their bones by taking just one pill a month.
Today the FDA approved a once-a-month version of the osteoporosis drug Boniva. The approval makes the drug the first once-a-month medicine designed to treat postmenopausal osteoporosis or any other chronic disease.
Boniva is part of a class of osteoporosis drugs known as bisphosphonates, which help build and maintain bone density (a measure of bone strength) in people with osteoporosis. Other drugs in this class include Actonel and Fosamax, but these must be taken daily or weekly.
Once-monthly Boniva is expected to become available in U.S. pharmacies in April. Boniva is also available as a daily osteoporosis drug.
12 Pills a Year
Nearly 50 million Americans over 50 are affected by or at risk for osteoporosis, mostly postmenopausal women.
Currently, other bisphosphonates are prescribed as daily or once-a-week pills. Researchers say the new treatment option may allow some people with osteoporosis to cut back on the number of pills they take to 12 tablets per year.
The once-monthly pill should be taken with plain water in the morning, and users should remain upright and avoid other foods or drinks for at least 60 minutes. This is to prevent the pill from getting stuck in the esophagus and causing damage and trouble swallowing.
Works as Well as Daily
The FDA approved the once-a-month version of Boniva based on clinical trials involving 1,602 postmenopausal women with osteoporosis. The studies showed that the once-monthly osteoporosis drug was at least as good as the daily dose in increasing bone density of the spine and lower back after one year of treatment.
Boniva is not recommended for people who are unable to stand or sit upright for at least 60 minutes, people with high calcium levels, or people with sensitivities to bisphosphonates. The most common side effects of bisphosphonates include stomach disorders and ulcers.
Boniva is made by Roche and GlaxoSmithKline. GlaxoSmithKline is also a WebMD sponsor.
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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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