FDA Drug Safety Communication

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FDA Date: 10/12/10

Boniva (ibandronate sodium) Injection FDA Drug Safety Communication

Safety Update for Osteoporosis Drugs, Bisphosphonates, and Atypical Fractures

FDA is updating the public regarding information previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis. This information will be added to the Warnings and Precautions section of the labels of all bisphosphonate drugs approved for the prevention or treatment of osteoporosis.

Bisphosphonates are a class of medicines that can be effective at preventing or slowing the loss of bone mass (osteoporosis) in postmenopausal women, thus reducing the risk of common osteoporotic bone fracture. The bisphosphonates affected by this notice are only those approved to treat osteoporosis, including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast (and their generic products).

This notice does not affect bisphosphonate drugs that only are used to treat Paget's disease or high blood calcium levels due to cancer (i.e., Didronel, Zometa, Skelid, and their generic products).

Although the optimal duration of bisphosphonate use for osteoporosis is unknown, these atypical fractures may be related to long-term term bisphosphonate use. FDA will require a new Limitations of Use statement in the Indications and Usage section of the labels for these drugs. This statement will describe the uncertainty of the optimal duration of use of bisphosphonates for the treatment and/or prevention of osteoporosis.

FDA recommends that healthcare professionals should:

- Be aware of the possible risk of atypical subtrochanteric and diaphyseal femur fractures in patients taking bisphosphonates.

- Continue to follow the recommendations in the drug label when prescribing bisphosphonates.

- Discuss the known benefits and potential risks of using bisphosphonates with patients.

- Evaluate any patient who presents with new thigh or groin pain to rule out a femoral fracture.

- Discontinue potent antiresorptive medications (including bisphosphonates) in patients who have evidence of a femoral shaft fracture.

- Consider periodic reevaluation of the need for continued bisphosphonate therapy, particularly in patients who have been treated for over 5 years.

These actions are part of an ongoing safety review of bisphosphonate use and the occurrence of atypical subtrochanteric and diaphyseal femur fractures, as previously announced in a Drug Safety Communication on March 10, 2010.

View the full FDA Drug Safety Communication on FDA.gov