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MONTREAL, June 17 /CNW Telbec/ - Osteoporosis patients on public drug
plans in Canada are a step closer to access to FOSAVANCE(R)70/5600
(alendronate sodium/cholecalciferol), an oral medicine indicated to treat
osteoporosis in postmenopausal women and in men. On June 17, 2009, the
Canadian Expert Drug Advisory Committee (CEDAC) through the Common Drug Review
(CDR) has recommended that FOSAVANCE(R) 70/5600 (alendronate
sodium/cholecalciferol) be listed on publicly funded drug plans. The CDR
recommended that alendronate 70mg/cholecalciferol 5600 IU (vitamin D3) be
reimbursed similar to generic alendronate. Furthermore, the Ontario Drug
Benefit (ODB) Formulary/Comparative Drug Index has announced that based on the
decisions by the Executive Officer and recommendations by the Committee to
Evaluate Drugs (CED), the Ontario government will be listing FOSAVANCE(R)
70/5600 (alendronate sodium/cholecalciferol) effective on June 23, 2009.
FOSAVANCE(R)70/5600 (alendronate sodium/cholecalciferol) is indicated for the
treatment of osteoporosis in post-menopausal women and in men. Developed by
Merck, alendronate sodium is a member of a class of non-hormonal drugs called
bisphosphonates. Cholecalciferol is the natural form of vitamin D.
"This listing by the Ontario government is good news for those
individuals with osteoporosis since it will help decrease their risk of
fracture and supports physicians in controlling osteoporosis. The
recommendation of the CDR may encourage publicly funded drug plans in the rest
of Canada to include FOSAVANCE(R) 70/5600 on their list of reimbursed
medicines," said Dr J. D. Adachi, Professor at the Department of Medicine, St.
Joseph's Healthcare, McMaster University. "Osteoporosis may significantly
affect life expectancy and quality of life due to the fragility fractures.
With these decisions, osteoporosis patients living in Canada will now have
better access to alendronate sodium/cholecalciferol in order to maintain bone
mineral density (BMD) and prevent fracture."
Too little vitamin D leads to inadequate calcium absorption and low
phosphate - the minerals that make bones strong. Even by eating a diet rich in
calcium or taking calcium supplement, patients cannot absorb calcium properly
unless there is adequate levels of vitamin D. Lower quantities of vitamin D
may lead to bone loss and osteoporosis. FOSAVANCE(R) 70/5600 (alendronate
sodium/cholecalciferol) makes the bone stronger and less likely to fracture,
thus reverses the progression of osteoporosis(1).
Information about FOSAVANCE(R)
FOSAVANCE(R) 70/5600 (alendronate sodium/cholecalciferol) was approved in
Canada in August 2008and is indicated for the treatment of osteoporosis in
postmenopausal women and osteoporosis in men. For the treatment of
osteoporosis, the alendronate sodium component increases bone mass and can
prevent fractures, including those of the hip and spine (vertebral compression
fractures)(1). Patients suffering from osteoporosis are at an increased risk
for vitamin D insufficiency. The recommended dosing regimen is one tablet of
FOSAVANCE(R) 70/5600 IU dosed once a week. It must be taken at least one-half
hour before the first food, beverage, or medication of the day with plain
water only. Osteoporosis Canada Guidelines recommend 800 IU vitamin D3 intake
per day in adults over 50 years. Side effects usually have been mild. Some
patients may experience digestive problems such as nausea, vomiting or black
and/or bloody stools. Some patients may experience bone, muscle and/or joint
pain which rarely is severe. Rarely, patients have had jaw problems associated
with delayed healing and infection, often following tooth extraction. Rarely,
patients have experienced fracture in a specific part of the thigh bone.
FOSAVANCE(R) 70/5600 (alendronate sodium/cholecalciferol) is also listed on
the Liste des medicaments du Québec, the Quebec public drug plan, and many
private drug plans across Canada.
About Merck Frosst Canada Ltd
At Merck Frosst, patients come first. Merck Frosst Canada Ltd is a
research-driven pharmaceutical company discovering, developing and marketing a
broad range of innovative medicines and vaccines to improve human health.
Merck Frosst is one of the top 25 R&D investors in Canada, with and investment
close to $110 million in 2007. More information about Merck Frosst and
FOSAVANCER is available at www.merckfrosst.com.
FOSAVANCE(R) is a Registered Trademark of Merck & Co., Inc. Used under
(1) FOSAVANCE(R), Product monograph
For further information:
For further information: Media: Natacha Raphael Manager, Public Affairs,
Merck Frosst Canada Ltd., (514) 428-3280