Fosavance®
Active ingredient: Alendronic acid, colecalciferol
Marketing authorisation holder: Merck Sharp & Dohme Ltd
Availability: Private Sector
Variations: Evidence has shown that the risk of developing atypical fracture of the femur is a class effect of
bisphosphonates particularly when used for long term treatment of osteoporosis. Atypical subtrochanteric and
diaphyseal femoral fractures were listed in the adverse effect list with a rare frequency. Patients should be
advised to seek professional advice if suffer from thigh, hip or groin pain during bisphosphonate treatment for
assessment for an incomplete femur fracture. In cases where atypical femur fracture is suspected,
discontinuation of bisphosphonate therapy shall be taken into account after an individual benefit-risk assessment
is carried out.
Reference: European Medicines Agency. Fosavance. [online]. 2011 Sep 13 [cited 2011 Sep 25]; Available from: URL:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000619/human_med_000800.jsp&murl=menus/medicine
s/medicines.jsp&mid=WC0b01ac058001d124