FDA Warns of Potential Side Effect of Bisphosphonate Use
By News Staff
1/9/2008
In contrast, the musculoskeletal pain symptoms described in the FDA alert may or may not resolve after discontinuing bisphosphonate use. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution.
The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.
Bisphosphonates decrease bone resorption by inhibiting osteoclast activity or through other mechanisms. Among the agents included in this class of drugs are alendronate sodium, marketed both as a generic and under the brand name Fosamax; ibandronate sodium, marketed as Boniva; and risedronate sodium, marketed as Actonel. Each of these drugs is indicated and widely prescribed for the treatment or prevention of osteoporosis in postmenopausal women.
Additional bisphosphonates currently approved for use in the United States are etidronate disodium, sold as Didronel; pamidronate disodium, sold as Aredia; tiludronate disodium, sold as Skelid; and zoledronic acid, sold (for different indications) under the brand names Reclast and Zometa.
Other indications for which agents in this class of drugs are used include:
- treatment of glucocorticoid-induced osteoporosis in men and women,
- treatment of Paget’s disease of bone in men and women,
- prevention and treatment of heterotopic ossification associated with total hip replacement or spinal cord injury,
- treatment of hypercalcemia of malignancy, and
- management of patients with multiple myeloma and bone metastases from solid tumors.
Adverse events associated with use of these or any other drugs should be reported to the FDA's MedWatch program.
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