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FDA approves Merck’s vitamin-enhanced Fosamax

The FDA has approved Merck & Co's Fosamax Plus D, a single once-weekly tablet to reduce the risk of hip and spine fractures in postmenopausal women with osteoporosis.

Fosamax Plus D (alendronate sodium/cholecalciferol), the only bisphosphonate with a weekly dose of vitamin D added, contains 70mg Fosamax (alendronate sodium) and 2800 IU vitamin D3, representing seven days’ worth of 400 IU of vitamin D.

Maintaining adequate levels of vitamin D is necessary for the development of strong bones because it helps increase the intestinal absorption of calcium and Fosamax, the world’s most prescribed osteoporosis treatment, has been demonstrated to significantly reduce the risk of both osteoporotic hip and spine fractures.

Recent research has found that a majority of Americans are not consuming enough vitamin D. A study, based on the Third National Health and Nutrition Examination Survey (NHANES III), estimated that over 70% of women age 51 to 70 and almost 90% of women over 70 are not getting an adequate intake of vitamin D from food and supplements.

For the treatment of osteoporosis, Fosamax Plus D increases bone mass and reduces the incidence of fracture. The product is also indicated to increase bone mass in men with osteoporosis.