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
