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FDA finds no fracture risk with bisphosphonates
Wednesday, March 10 2010 | Comments
What's This?
The Food and Drug Administration said its review of data has shown no clear connection between bisphosphonate use and the risk of atypical subtrochanteric femur fractures, or fractures in the bone just below the hip joint, but noted that it is working with outside experts to gather more information on this issue.The FDA explained that recent reports have raised the issue about whether an increased risk of this type of fracture is seen in patients with osteoporosis using bisphosphonates, which include Merck & Co. Inc.'s Fosamax (alendronate sodium) and its generic equivalents, Roche and GlaxoSmithKline Plc's Boniva (ibandronate sodium), Procter & Gamble Pharmaceuticals and Sanofi-Aventis Group's Actonel (risedronate sodium) and Novartis AG's Reclast (zoledronic acid).
In June 2008, the agency requested information from all bisphosphonate drug manufacturers regarding this potential safety signal, which was seen in published case reports. The agency reviewed these data and did not find an increase in this risk in women using these drugs.
The FDA also reviewed a published article that evaluated data from two large observational studies in patients with osteoporosis. Results from this analysis showed that similar numbers of atypical subtrochanteric femur fractures relative to classical osteoporotic hip fractures were seen in the women who were taking bisphosphonates and in the women not using them.
The agency advised health care professionals to follow the labels on bisphosphonates when prescribing them and told patients not to discontinue their use without consulting their physicians. Hip or leg pain should be discussed with health care professionals, the FDA said.
The FDA said it will review new information about this topic as it becomes available.
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