FDA Drug Safety Communication

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FDA Date: 1/6/08

Boniva Injection (ibandronate sodium) FDA Drug Safety Communication

FDA Information for Healthcare Professionals: Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa)

FDA is highlighting the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics.

Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.

FDA also recommends the following:

- Monitor patients who have severe musculoskeletal pain to determine if there are alternative causes of the pain if symptoms do not lessen or resolve following withdrawal of the bisphosphonate.

- Consider the benefits and risks of bisphosphonate use. Bisphosphonates provide benefit in treating and preventing osteoporosis and treating hypercalcemia of malignancy, Paget's disease, and patients with multiple myeloma and bone metastases from solid tumors.

This information reflects the current analysis of data available to FDA concerning this drug. FDA intends to update this communication when additional information or analyses become available.

View the full FDA Drug Safety Communication on FDA.gov