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FDA OKs First IV Osteoporosis Drug
Jan. 13, 2006 -- The FDA has approved the first intravenous drug to treat osteoporosis in postmenopausal women.
The drug is a new form of Boniva, an osteoporosis medicine that is already approved in pill form. Boniva pills are available to take on a daily schedule or monthly.
Intravenous Boniva is an alternative for women who have trouble swallowing pills or sitting upright for 30-60 minutes after taking the pills, a requirement for patients taking osteoporosis drugs like Boniva. Sitting upright helps prevent damage to the esophagus.
Intravenous Boniva is given directly through a vein every three months and must be given by a doctor or other health care provider. The procedure takes about 15-30 seconds, states a news release from Roche and GlaxoSmithKline, drug companies that co-promote Boniva.
Women taking Boniva must also take supplemental calcium and vitamin D to help their bones. Boniva is not recommended for women with severe kidney problems.
Boniva Study
The FDA approved intravenous Boniva based on a study of more than 1,300 postmenopausal women with osteoporosis, according to Roche and GlaxoSmithKline. The drug companies' news release describes the study.
Participants were all postmenopausal women. They either got intravenous Boniva or took a Boniva pill once daily.
Bone density improved in both groups. The bigger gains occurred in the intravenous group.
Overall safety and tolerability were similar for both forms of Boniva. The most common adverse events were joint pain, back pain, flu, abdominal pain, and inflammation of the nose and throat.
Fixing Weakened Bones
In osteoporosis, the bones are weaker and less dense than normal, making fractures more likely.
Osteoporosis becomes more common with age. It's mostly seen in women older than 50, petite women, women with a family history of osteoporosis, smokers, and white or Asian women. However, men can also develop osteoporosis.
Boniva belongs to a family of drugs called biphosphonates, which also include Actonel and Fosamax. Biphosphonates have been shown to slow bone loss, increase bone density, and reduce the risk of bone fractures, including in the spine.
There are other types of osteoporosis drugs. Fortical and Miacalcin are made from a hormone called calcitonin and delivered by nasal spray. Forteo is a man-made hormone treatment given by injection under the skin. Evista is an estrogen-like drug. Postmenopausal hormone replacement therapy has also been used to treat osteoporosis.
Diet and exercise are also important. Getting enough vitamins and minerals -- including calcium and vitamin D -- are essential for bone health. Weight-bearing exercise -- such as lifting weights, walking, running, or dancing -- also builds bone strength.
Though osteoporosis is usually seen in older adults, bones take a lifetime of care. Making bones as strong as possible when you're young gives you more protection against osteoporosis later in life.
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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.
Taking Vitamin D and Calcium Together
Osteoporosis specialist Dr. Ethel Siris on why it's so important to take calcium with Vitamin D.
