Bisphosphonate safety alert

The FDA has announced the possibility of severe and sometimes incapacitating bone, joint, and/or muscle 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.

The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate. The risk factors for and incidence of the severe musculoskeletal pain are unknown at this time. Healthcare professionals treating patients with bisphosphonates experiencing severe musculoskeletal pain symptoms may consider temporary or permanent discontinuation of these drugs.

Bisphosphonates are marketed as Actonel, Actonel Plus Calcium, Aredia, Boniva, Didronel, Fosamax, Fosamax Plus D, Reclast, Skelid, and Zometa.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150837.htm.