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FDA Approves New Drug to Fight Osteoporosis

The Food and Drug Administration (FDA) approved the drug teriparatide yesterday to combat osteoporosis, a disease affecting 10 million Americans, mostly women. Osteoporosis is a condition in which bones become brittle and thin, leading to a greatly increased risk of fractures. The disease primarily affects post-menopausal women. Teriparatide works to increase the action of the body’s bone-building cells, causing them to become denser and less likely to fracture, according to the Associated Press.

The drug was studied in almost 1,600 post-menopausal women and 437 men with osteoporosis. Both women and men taking a combination of teriparatide, calcium, and vitamin D showed significant increases in bone density compared to those only taking the calcium and vitamin D supplements, according to the FDA. In addition, women taking the drug showed a reduced risk of bone fractures.

In studies of the drug on rats, some animals contracted a rare and serious bone cancer called osteosarcomas. Although none of the women and men involved in clinical trials developed this cancer, the FDA has not ruled out the possibility that humans taking the drug may have a greater risk of developing osteosarcomas. Some patients in the study experienced mild side effects including nausea, dizziness, and leg cramps.

Sources:

FDA press release 11/26/02; Associated Press 11/26/02

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