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
