FDA reviews info about Fosamax, atypical femur fractures

Fosamax Injury Lawyers
FDA reviews information about Fosamax and atypical femur fractures

The Food & Drug Administration (FDA) issued a safety announcement in March 2010 about the ongoing review of oral bisphosphonates like Fosamax and atypical femur fractures.

Questions have been raised as to about there is an increased risk of atypical femur fractures in patients with osteoporosis who take bisphosphonate drugs like Fosamax. At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical femur fractures. FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight.

In June 2008, the FDA requested information from all bisphosphonate drug manufacturers like Merck, Inc. regarding the potential for femur fractures. All available reports on femur fracture cases and clinical trial data were requested. The FDA’s review of these data did not show an increase in this risk in women using these medications.

Fosamax Femur Fractures
Additionally, the FDA reviewed a December 2008 article in the Journal of Bone and Mineral Research analyzing data from two large observational studies in patients with osteoporosis. The authors concluded that atypical subtrochanteric femur fractures had many similar features in common with classical osteoporotic hip fractures, including patient age, gender, and trauma mechanism.

The data showed that patients taking bisphosphonates and those not taking bisphosphonates had similar numbers of atypical subtrochanteric femur fractures relative to classical osteoporotic hip fractures.

The FDA will continue to review new information as it becomes available and will update the public once the agency’s review is complete. The FDA is also recommending that doctors be aware of femur fractures for patients taking Fosamax.

Contact a Fosamax Lawyer

Have you or a loved one suffered a femur fracture even thought you have been taking Fosamax to build your bone mass? If the answer is yes, contact us today for your free legal consultation regarding your case with a skilled Fosamax femur fracture lawyer.