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FDA approves Actonel (risedronate sodium) for postmenopausal osteoporosis

Published on April 24, 2008 at 10:05 PM · 1 Comment

The U.S. Food and Drug Administration (FDA) approved a new once-a-month dose (150 mg) of Actonel (risedronate sodium) tablets for the treatment and prevention of postmenopausal osteoporosis. Actonel is approved to reduce the risk of fractures in postmenopausal women with osteoporosis.

The FDA approval of the once-a-month dose is based on a study comparing Actonel 150 mg once monthly to Actonel 5 mg daily. Similar increases in bone mineral density (BMD) were seen among patients taking either once-a-month or daily dosing regimens.

Over fifty-five million prescriptions of Actonel have been filled in the U.S. alone since its approval for osteoporosis in 2000. Those who want to learn more about postmenopausal osteoporosis and treatment with Actonel should visit: http://www.actonel.com/.

Postmenopausal osteoporosis is a silent disease that affects millions of women, making their bones weak and more likely to fracture over time. In fact, in the U.S. today, 8 million women are estimated to already have osteoporosis, and almost 27 million more are estimated to have low bone mass, placing them at increased risk for fracture. Each year the incidence of osteoporosis-related fractures is greater than the incidence of heart attacks, strokes, and breast cancer combined. The good news is that there are prescription medications available that effectively reduce fractures.

Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min).

Comments
  1. E Lutton E Lutton United Kingdom says:

    I am taking paracetamol every four hours. Hands become very stiff and shoulders very painful, particularly when not in use. I am having difficulty sleeping and up every night with pain. Is this as a result of taking Actonel which I have been on for ten months.

    When I initially started taking Actonel I had sore hands and thumbs which lasted about three days and then went.  I also have large hives and itchy rashes over my body which would last for about thirty minutes before, maybe, coming out somewhere else.

    Is this normal and what can I do?

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News-Medical.Net.



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