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Osteoporosis Medication Now Registered


9 July 2008

Osteoporosis Medication FOSAMAX PLUS 5600IU Now Registered

Merck Sharp & Dohme New Zealand (MSDNZ) has gained registration for its osteoporosis medication FOSAMAX PLUS™ 5600 IU.

MSDNZ Managing Director, Alister Brown, says "This will be welcome news for the many doctors who have been calling for increased Vitamin D supplementation in osteoporosis medication.

"Merck & Co has long recognised the importance of Vitamin D in improving bone health and it was the first company in the world to develop a bisphosphonate treatment containing Vitamin D – FOSAMAX PLUS 2800IU which was launched in New Zealand last year.
"Recently, treatment guidelines have recommended even higher levels of Vitamin D, which resulted in Merck & Co developing FOSAMAX PLUS 5600IU."
FOSAMAX PLUS 5600IU contains a weekly dose of two therapies – FOSAMAX™(alendronate sodium, 70mg) and Vitamin D³ (cholecalciferol, 5600 IU).

New Zealanders with osteoporosis are recommended to achieve a daily intake of 20ug (800IU) of Vitamin D per day. However an international study of Pacific Rim countries found that 60 percent of postmenopausal women with osteoporosis had low Vitamin D levels .

Dr John Elliot, Geriatrician in the bone clinic at Princess Margaret Hospital, Christchurch, says "It is important to note that the quantity of cholecalciferol in FOSAMAX PLUS® 5600IU is sufficient to use as the sole ongoing maintenance of Vitamin D in most of those treated for osteoporosis.

"This is a significant innovation as a considerable number of people do not receive adequate Vitamin D from casual exposure to sunlight. Getting enough Vitamin D is important because deficiency is linked with falls and fragility in both women and older men.

"Those who are deficient in Vitamin D, however, may well need an additional initial boost with a loading dose of Vitamin D to correct the low levels before going onto FOSAMAX PLUS 5600IU.

"We know that in New Zealand there are an estimated 350,000 people over the age of 50 with osteoporosis. Osteoporosis is a major cause of long-term disability and death, with almost 40 percent of women over 50 and 13 percent of men suffering an osteoporotic fracture.

"It is also estimated that 22 percent of people die within 12 months following a hip fracture. Therefore it is vital that we do everything we can to ensure osteoporosis treatments work as effectively as possible."

Executive Director of Osteoporosis New Zealand, Julia Gallagher says, "Osteoporosis New Zealand is pleased to see this increased level of Vitamin D in FOSAMAX PLUS 5600IU as it aligns with recommended guidelines and evidence is very clear that many people who incur fractures have insufficient Vitamin D.

"Vitamin D has a very important role to play in maintaining bone health and is not easy to obtain as people are spending less time in the sun and foods contain very little Vitamin D. However the amount contained in FOSAMAX PLUS 5600IU will address insufficiency and provide a sufficient dose to help reduce fracture risk in the elderly."

MSDNZ is in discussions with PHARMAC to replace the currently subsidised FOSAMAX PLUS 2800IU with FOSAMAX PLUS 5600IU.

Please note the Minimum Product Information is contained in the following pages.

TAPS Approval No: NA3009


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