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Health Canada Warnings
ACLASTA (zoledronic acid 5mg/100mL) solution for intravenous infusion - Association with renal dysfunction - Novartis Pharmaceuticals Canada Inc. Oct 14 2010Novartis in collaboration with Health Canada, is notifying healthcare professionals and the public of reports of renal impairment and renal failure requiring dialysis or with fatal outcome that occurred in patients with history of renal impairment or other risk factors receiving ACLASTA (zoledronic acid).

Information Update
2010-175
October 14, 2010
For immediate release

OTTAWA - Health Canada is informing healthcare professionals and Canadians of an ongoing safety review of a group of drugs known as bisphosphonates and a possible increased risk of a rare but serious type of thigh bone fracture. Health Canada's review will include consideration of the labelling change recently announced by the U.S. Food and Drug Administration (U.S. FDA  news release).

There have been recent scientific reports suggesting a connection between the long-term use of bisphosphonates and an unusual type of thigh bone fracture known as an "atypical femur fracture," including a recent report released by the American Society for Bone and Mineral Research (  ASBMR news release). The report observed that while these types of rare fractures may occur in both the general population and in patients treated with a bisphosphonate, the risk appears potentially higher in those using a bisphosphonate, particularly after several years of therapy. 

Complete article at:
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_175-eng.php


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