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FDA Approves New Drug, Actonel, to Treat and Prevent Osteoporosis

The U.S. Food and Drug Administration (FDA) has approved the drug Actonel (generic name, risedronate sodium) to help treat and prevent osteoporosis, a degenerative bone disease. In clinical trials , Actonel was shown to improve bone mineral density and reduce the risk of broken bones in post-menopausal women who suffer from osteoporosis. Unlike some of the other drugs used to treat osteoporosis, actonel is not a hormone and does not provide the benefits or risks of estrogen or progestin. Actonel, like Fosamax (generic name, alendronate) belongs to a group of drugs called bisphosphonates.

In a study conducted at the University of California at San Francisco prior to FDA approval, researchers observed 2,500 post-menopausal woman between 1993 and 1998. In 450 women who were given Actonel, the risk of spinal fractures was reduced by 41% after three years compared with those who were given a placebo (inactive pill). Actonel was also shown to reduce the frequency of wrist and hip fractures by 39%. A previous clinical trial that enrolled 4,875 post-menopausal women with osteoporosis, showed that taking Actonel reduced the incidence of spinal fractures by almost 50%.

Patients are usually prescribed five milligrams of Actonel daily. Like Fosamax, Actonel is typically taken in the morning while in an upright position (sitting or standing) before the patient has had any food or drink, except plain water. Patients should not eat or drink anything except plain water for 30 minutes after taking Actonel.

Though side effects of Actonel are generally mild, physicians do not recommend that patients with severe kidney disorders or stomach or digestive problems take Actonel. The most common side effects of Actonel noted in clinical trials were indigestion, nausea and abdominal pain. Other side effects may include allergic reactions or infections. As with other drug therapies used to treat osteoporosis, patients who take Actonel should ask their physician about also taking daily calcium and vitamin supplements.

Actonel is effective against osteoporosis, a degenerative bone disease that primarily affects post-menopausal women. It is estimated that one-third of women over age 50 have osteoporosis. Osteoporosis affects roughly 25 million Americans and is currently one of the most under-diagnosed and under-treated disorders in medicine.

In addition to treating and preventing osteoporosis, Actonel is also FDA approved to treat Paget’s disease of the bone, a debilitating bone disease of unknown cause. Actonel is marketed by Procter & Gamble Pharmaceuticals and Aventis Pharmaceuticals Inc. With an aging population, analysts expect the overall market for treating osteoporosis to double by 2005. However, physicians say that the majority of women and men with osteoporosis still go undiagnosed.

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