Bisphosphonate Drugs Product Labeling Changes April 2013
Osteonecrosis of the jaw (ONJ)
- The risk of ONJ may increase with duration of exposure to Bisphosphonates.
- Pulmonary - asthma exacerbations
Boniva (Ibandronate) Injection
Cases of anaphylaxis, including:
- fatal events, have been reported.
WARNINGS AND PRECAUTIONS
- 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…
- Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Boniva and other bisphosphonates…
Postmarketing Experience – Hypersensitivity:
- Asthma exacerbation
- Anaphylactic Reaction