Label Changes for:

Zometa (zoledronic acid) Injection

March 2012

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

 

March 2012

WARNINGS AND PRECAUTIONS

Atypical subtrochanteric and diaphyseal femoral fractures
  • Atypical subtrochanteric and diaphyseal femoral fractures have been reported in patients receiving bisphosphonate therapy, including Zometa. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to just above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. These fractures occur after minimal or no trauma. Patients may experience thigh or groin pain weeks to months before presenting with a completed femoral fracture….

ADVERSE REACTIONS

Postmarketing Experience

Atypical subtrochanteric and diaphyseal femoral fractures

  • Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, including Zometa
     

 

February 2011

 

ADVERSE REACTIONS

Postmarketing Experience
  • ...pyrexia, asthenia, fatigue, or malaise persisting for greater than 30 days has been observed

 

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