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FDA updates bisphosphonate labels for osteoporosis

October 13, 2010 11:36 PM UTC

FDA will update the labels of all bisphosphonates approved for osteoporosis to warn of the risk of atypical fractures of the thigh. The label update is in line with a recommendation in September from a task force of the American Society for Bone and Mineral Research, which reviewed data that suggested the risk of atypical femoral fractures increases with the duration of exposure to bisphosphonates for osteoporosis. FDA, which noted that the optimal duration of bisphosphonate treatment for osteoporosis is unknown, said it will continue its evaluation of data for long-term use and will provide additional guidance at the completion of its review. ...