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U.S. Department of Health and Human Services

Safety

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Bisphosphonates Class Label Change

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2011

  • Actonel (risedronate sodium) tablets
  • Actonel with Calcium (risedronate sodium with calcium carbonate tablets)
  • Atelvia (risedronate sodium) delayed-release tablets
  • Boniva (ibandronate sodium) tablets
  • Fosamax (alendronate sodium) tablets and oral solution
  • Fosamax Plus D (alendronate sodium/cholecalciferol) Tablets
  • Reclast (zoledronic acid) Injection

 

Summary View

5 WARNINGS AND PRECAUTIONS

5.5 Atypical Subtrochanteric and Diaphyseal Femoral Fractures
  • Atypical, low-energy, or low trauma  fractures of the femoral shaft have been reported in bisphosphonate-treated  patients. These fractures can occur anywhere in the femoral shaft from just.....

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