Merck & Co., Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved FOSAMAX PLUS D (alendronate sodium/cholecalciferol), a single once-weekly tablet containing 70 mg FOSAMAX® (alendronate sodium) and 2800 IU vitamin D3, representing seven days worth of 400 IU of vitamin D. (The recommended intake of vitamin D is 400-800 IU daily). FOSAMAX has been demonstrated to reduce the risk of both hip and spine fractures in postmenopausal women with osteoporosis and is now the only bisphosphonate with the added benefit of a weekly dose of vitamin D.
“The approval of FOSAMAX PLUS D is important news for women diagnosed with osteoporosis,” said Robert Heaney, M.D., professor of medicine, Creighton University, Omaha, Nebraska. “This product will provide physicians with an important new option providing the well documented clinical benefit of FOSAMAX with the added advantage that those patients taking it are receiving a weekly dose of vitamin D. Having a product like FOSAMAX PLUS D available to help physicians better manage vitamin D nutrition in their patients should be welcomed news for the estimated 10 million Americans who have osteoporosis and the physicians who treat them.”
Maintaining adequate levels of vitamin D is necessary for the development of strong bones because it helps increase the intestinal absorption of calcium. Vitamin D insufficiency is associated with reduced calcium absorption, bone loss and increased risk of fracture. Patients at increased risk for vitamin D insufficiency (e.g., those who are nursing-home bound, chronically ill, over the age of 70 years) and with gastrointestinal malabsorption syndromes should receive vitamin D supplementation in addition to that provided in FOSAMAX PLUS D.
FOSAMAX PLUS D provides the proven power of FOSAMAX, the world’s most prescribed osteoporosis treatment, which has been demonstrated to significantly reduce the risk of both osteoporotic hip and spine fractures. The sustained efficacy of FOSAMAX for the treatment of osteoporosis in postmenopausal women was demonstrated in a trial that found in over 10 years of therapy FOSAMAX 10 mg once daily maintained or continued to build bone.
FOSAMAX PLUS D is indicated for the treatment of osteoporosis in postmenopausal women. For the treatment of osteoporosis, FOSAMAX PLUS D increases bone mass and reduces the incidence of fracture, including those of the hip and spine. FOSAMAX PLUS D is also indicated to increase bone mass in men with osteoporosis.
FOSAMAX PLUS D, like other bisphosphonate containing products, should be used with caution in people with certain stomach or digestive problems. FOSAMAX PLUS D should not be used if the patient has certain disorders of the esophagus that delay emptying or if the patient is unable to stand or sit upright for at least 30 minutes. In addition, FOSAMAX PLUS D should not be used in patients with severe kidney disease or low levels of calcium in their blood, in patients who are allergic to FOSAMAX PLUS D or in patients who are pregnant or nursing. FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency.