Label Changes for:

Pamidronate disodium injection

July 2009

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2009

PRECAUTIONS

Osteonecrosis of the Jaw
  • Osteonecrosis of the jaw (ONJ) has been reported predominantly in cancer patients treated with intravenous bisphosphonates, including pamidronate disodium...

ADVERSE REACTIONS

Post-Marketing Experience
  • description of osteonecrosis of the jaw
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