FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures
03-10-2010
Patients and healthcare professionals may have questions about oral bisphosphonate medications and atypical subtrochanteric femur fractures – fractures in the bone just below the hip joint. Oral bisphosphonates are commonly prescribed to prevent or treat osteoporosis in postmenopausal women. Common brand names of medications in this class include Fosamax, Actonel, Boniva, and Reclast.
Recent news reports have raised the question about whether there is an increased risk of this type of fracture in patients with osteoporosis using these medications. At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric 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 into this issue.
Meanwhile the FDA is recommending patients should not stop taking their medication unless told to do so by their healthcare professional.
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm
http://certifiedbug.com/blog/2010/03/09/osteoporosis-drugs-possible-effects-of-long-term-use/
Merck Responds to News Reports about FOSAMAX® (alendronate sodium) Tablets
http://merck.com/newsroom/company-statements/2010_0310.html
AAOS: American Academy of Orthopaedic Surgeons®: Quantity vs. quality: Long-term use of bone-building osteoporosis drugs
Bisphosphonate treatments, proven to enhance bone density and reduce fracture incidence in post-menopausal women, may adversely affect bone quality and increase risk of atypical fractures of the femur when used for four or more years, according to preliminary research presented today at the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS).
http://www6.aaos.org/news/pemr/releases/release.cfm?releasenum=877
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