The FOSAMAX Induced Femur Fractures - HB Litigation Conferences

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Management recommendations: Dr. Joseph Lane “Lane advised physicians to check markers of bone metabolism in patients taking bisphosphonates and consider a drug holiday if bone metabolism appears to have stopped. He said he and his colleagues now discontinue bisphosphonate treatment in patients after 5 years; these patients are given calcium and vitamin D and are monitored for bone loss during that holiday. Bisphosphonate treatment is resumed in patients who experience bone loss, but at the lowest possible dose. ‘Until we get more data from industry and the FDA, we are stepping back,’ he said.” Source: Kuehn, B, 2009. Long-term risks of bisphosphonates probed.” JAMA 301:710-711.
Unusual Mid-shaft <strong>Fractures</strong> during Long- term Bisphosphonate <strong>The</strong>rapy - 2010 13 women (from 2 hospitals) sustained atraumatic mid-shaft fractures – 11 femur, 1 humerus, and 1 pelvis &right tibia. All had been only standing, walking, or turning around. 10 were on alendronate (3- 11 yrs) and 3 on risedronate (Actonel) (2-5 yrs). 10 were also on estrogen, tamoxifen, or prednisone. 3 of the 11 patients with a femur fracture had bilateral fractures. Of 11 patients with available information, 10 had delayed fracture healing. Among 6 patients who had bone biopsies, all had severe depression of bone formation, with minimal or no osteoblasts. Note the high % who were also on other meds – a likely increased risk factor. Odvina CV, et al. 2010. Clinical Endocrinology 72:161-168.
Page 1 and 2: The FOSAMAX Induced Femur Fractures
Page 3 and 4: Fosamax indications include: • Tr
Page 5 and 6: Normal Moderate Osteoporosis Severe
Page 7 and 8: Pathophysiology of the Injury The l
Page 9 and 10: FOSAMAX Atypical Femur Fractures (A
Page 11 and 12: Fracture Intervention Trial (FIT)
Page 13 and 14: Dr. Susan Ott M.D. “I believe the
Page 15 and 16: T-1.8; 5 yrs on alendronate; FIT N
Page 17: Flex Fracture Outcome Years 5-10 %
Page 21 and 22: Structural effects of long-term bis
Page 23 and 24: Femoral insufficiency fractures ass
Page 25 and 26: Management recommendations: Post-op
Page 27 and 28: JAMA, Park-Wyllie 2011: BP Use and
Page 29 and 30: Fosamax Label: Timeline
Page 31 and 32: Fosamax 2010 Task Force Report
Page 33 and 34: Information for FDA warning to doct
Page 35 and 36: Fosamax Label Warnings/Precautions:
Page 37 and 38: Fosamax Label Warnings/Precautions:
Page 39 and 40: Jan. 2011: Update on Femur Fracture
Page 41 and 42: FDA Bisphosphonate Advisory Committ
Page 43 and 44: FDA BP AdComm Speaker and Written S

The FOSAMAX Induced Femur Fractures - HB Litigation Conferences

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