Reactions 1631, p1 - 10 Dec 2016

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Higher risk of jaw osteonecrosis with IV bisphosphonates Use of IV bisphosphonates is associated with a higher risk of osteonecrosis of the jaw versus oral bisphosphonates, says Health Canada. Bisphosphonates are prescription drugs (available in IV and oral formulations) that are used to strengthen bones in a variety of bone-related diseases. The risk of osteonecrosis of the jaw (hereafter jaw osteonecrosis) associated with the use of bisphosphonates is wellknown and information regarding this adverse effect is included in the safety information for products available in Canada. Health Canada’s safety review into the use of bisphosphonates and the known risk of jaw osteonecrosis was triggered by an EMA review of a side effect report of zoledronic acid (Zometa, Aclasta). At the time of the review, the agency had received 125 Canadian reports of jaw osteonecrosis linked with the use of bisphosphonates, particularly in cancer patients. In addition to the higher risk of jaw osteonecrosis with IV bisphosphonates, compared with oral formulations, "higher doses and strengths as well as longer treatment periods also contribute to the risk", stated Health Canada. Although the Canadian product information for bisphosphonates already includes a warning about the risk of jaw osteonecrosis, "there were differences in the way the risk was described for the different drugs in this class", added the agency. Consequently, the agency is working with manufacturers to update the Canadian product safety information for bisphosphonates. The updated information will also recommend treatment stoppage if jaw osteonecrosis occurs during bisphosphonate therapy, and a delay in starting bisphosphonates if patients have unhealed open wounds in their mouth. All bisphosphonate formulations will also mention additional risk factors for jaw osteonecrosis revealed in this review, such as dental conditions and procedures, radiation therapy, anaemia and bleeding disorders (specifically coagulopathies). Health Canada. Summary Safety Review - Bisphosphonates - Assessing the Risk of Jaw Bone Loss (osteonecrosis of the jaw). Internet Document : 25 Nov 2016. Available from: URL: http://www.hc-sc.gc.ca/dhp-mps/medeff/reviews-examens/ 803211506 bisphosphonates-eng.php

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Reactions 10 Dec 2016 No. 1631