Label Changes for:
Reclast (zoledronic acid) Injection
January 2011
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
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
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.....
