Label Changes for:

Zometa (zoledronic acid) Injection Single Dose Vial

November 2012

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

 

 

November 2012

ADVERSE REACTIONS

Clinical Studies Experience
Postmarketing Experience
  • Acute Phase Reaction - Within three days after Zometa administration, an acute phase reaction has been reported, with symptoms including pyrexia, fatigue, bone pain and/or arthralgias, myalgias, chills, and influenza-like illness; these symptoms usually resolve within three days of onset, but resolution could take up to 7 to 14 days. However, some of these symptoms have been reported to persist for a longer duration.
Hypersensitivity Reactions
  • bronchospasms, interstitial lung disease (ILD) with positive re-challenge

 

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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