FDA is alerting healthcare professionals that severe bone, joint, or muscle pain can occur in patients taking bisphosphonate drugs such as Fosamax (alendronate sodium), Actonel (risedronate sodium), Reclast (zoledronic acid) and Boniva (ibandronate sodium). These drugs are used to treat osteoporosis and certain other diseases.
This severe, sometimes incapacitating musculoskeletal pain has occurred within days, months, or even years after starting bisphosphonates. In the most serious cases, the pain was so severe that patients could not continue their normal activities. Some patients have complete relief of symptoms after they stop taking the drug, while others have reported slow or incomplete resolution.
Note that these events are different from the acute phase response some patients experience after the first treatment with IV bisphosphonates, and occasionally after the first dose of oral bisphosphonates.
Although severe musculoskeletal pain is described in the labeling for all bisphosphonates, this association may be overlooked by practitioners because they may assume that the patient's pain can be attributed to osteoporosis itself.
Practitioners should consider whether musculoskeletal pain in patients on bisphosphonates might be caused by the drug, and consider discontinuing it either temporarily or permanently.
FDA MedWatch Safety Alert. Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa). January 7, 2007.