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Fosamax Femur / Thigh Bone Fractures: September 2010 Task Force Report Finds Possible Link

FDA Could Require Merck To Increase Warning About Risk Of Atypical Subtrochanteric And Diaphyseal Femoral Fractures


UPDATE:  FDA Drug Safety Communication: Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures

Safety Announcement

[10-13-2010] The U.S. Food and Drug Administration (FDA) is updating the public regarding information previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis. This information will be added to the Warnings and Precautions section of the labels of all bisphosphonate drugs approved for the prevention or treatment of osteoporosis....

The "FDA Statement on ASBMR report: Possible Increased Risk of Certain Types of Thigh Bone Fractures with Long-Term Bisphosphonates Use", which was published on September 14, 2010, indicates that the FDA may want Merck & Co., Inc. to revise the package insert, or label, for its osteoporosis drug Fosamax to add a better warning about an apparent increased risk of atypical femur fractures.

This September 2010 FDA document discusses the finding of a new task force report on bisphosphonates done by the American Society for Bone and Mineral Research (ASBMR) at the request of the FDA.

Also on September 14, 2010, the Journal of Bone and Mineral Research published online this article "Atypical subtrochanteric and diaphyseal femoral fractures: Report of a task force of the American Society for Bone and Mineral Research" (PDF format of full article).

Given that this ASBMR Task Force report finds an apparent association between bisphosphonates, like Fosamax (alendronate), and atypical femur fractures in osteoporosis patients, the FDA will likely consider requiring drug companies like Merck to make a label change to increase the warning about the risk of developing this atypical subtrochanteric and diaphyseal femoral fracture side effect.

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