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2007-8-28 16:14:48

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The Food and Drug Administration had approved for the first time a once-a-year treatment for osteoporosis, which can lead to bone fractures, Swiss drug maker Novartis A, the manufacturer of the anti-osteoporosis drug, said on Friday.

Reclast can be used only once in a year and it takes only 15 minutes to use in women with post-menopausal osteoporosis. In comparison, other osteoporosis drugs need to be taken daily, weekly or monthly.

Probably due to the convenience of using the drug, Reclast helps prevent more cases of osteoporosis, according to a study sponsored by the drug maker and published earlier this year in the New England Journal of Medicine.

The study of more than 7,700 women showed Reclast reduced the risk of spine fracture by as much as 70 percent compared to 40 to 50 percent reduction in risk of spinal fractures by taking oral anti-osteoporosis.

Specifically, 3.3 percent of those who used Reclast experienced a fracture compared to 11 percent of patients who used a placebo.

One adverse effect associated with use of Reclast, according to Reuters' reporting, is that the drug was associated with elevated risk of atrial fibrillation, a type of abnormal heart rhythm.

The study found 1.3 percent of patients on Reclast had that problem compared to just 0.4 percent among those on a placebo.  Novartis said the cases had nothing to do with its drug.

Reclast is already sold in the U.S. for treating a bone disorder called Paget's disease and belongs to a class of osteoporosis drugs called bisphosphonates.

Oral bisphosphonate pills including similar drugs such as Fosamax, Boniva and Actonel should be taken before meal with a full glass of water, and patients must remain upright for at least 30 minutes.
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