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Label Changes for:

Didronel (etidronate disodium) Tablets

April 2015

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

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

Actonel (risedronate sodium) Tablets
Actonel with Calcium (risedronate sodium tablets with calcium carbonate tablets, USP)
Atelvia (risedronate sodium) Delayed-release Tablets
Binosto (alendronate sodium) Effervescent Tablets for Oral Solution
Boniva (ibandronate sodium) Injection
Boniva (ibandronate sodium) Tablets
Didronel (etidronate disodium) Tablets
Fosamax Plus D (alendronate sodium/cholecalciferol) Tablets
Fosamax (alendronate sodium) Tablets and Oral Solution
Prolia (denosumab)

April 2015

WARNINGS AND PRECAUTIONS

Jaw Osteonecrosis
  • Known risk factors for osteonecrosis of the jaw include…..concomitant therapies (for example, angiogenesis inhibitors)
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