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U.S. Department of Health and Human Services

Safety

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Bisphosphonate Drugs Product Labeling Changes April 2013

April 2013 

Summary View

 

*Bisphosphonate Drug

Didronel (Itidronate Disodium) Tablets
Binosto (Alendronate Sodium) Effervescent Tablets for Oral Solution
Actonel (Risedronate Sodium) Tablets
Fosamax (Alendronate Sodium) Tablets and Oral Solution
Fosamax Plus D (Alendronate Sodium/Cholecalciferol) Tablets
Actonel with Calcium (Risedronate Sodium with Calcium Carbonate) Tablets
Atelvia (Risedronate Sodium) Delayed-release Tablets
Boniva (Ibandronate Sodium) Tablets
 

PRECAUTIONS

Osteonecrosis of the jaw (ONJ)
  • The risk of ONJ may increase with duration of exposure to Bisphosphonates.

ADVERSE REACTIONS

Postmarketing Experience
  • Pulmonary - asthma exacerbations

 

Boniva (Ibandronate) Injection

CONTRAINDICATIONS

Cases of anaphylaxis, including:
  • fatal events, have been reported.

WARNINGS AND PRECAUTIONS

Anaphylactic Reaction:
  • Cases of anaphylaxis, including fatal events, have been reported in patients treated with Boniva Injection…
  • Osteonecrosis of the Jaw
    • Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates, including Boniva jection…
    Musculoskeletal Pain
    • Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Boniva and other bisphosphonates…

    ADVERSE REACTIONS

    Postmarketing Experience – Hypersensitivity:
    • Asthma exacerbation
    • Anaphylactic Reaction