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Overview
The FDA has recently posted information on severe bone, joint and muscle pain in patients taking the oral bisphosphonates Fosamax and Actonel on its Web site for health care professionals, FDA Patient Safety News  . This adverse reaction was also reported in the Archives of Internal Medicine in 2005. 1
As of February 2005, there were 112 reports of severe pain in patients taking Fosamax, and six reports of severe pain in patients taking Actonel. Since this adverse event has been reported with two bisphosphonates, the FDA wants health care providers to be aware that this may be a class effect for these drugs. Symptoms include severe and often disabling pain in bones, joints, and muscles throughout the body. In some patients, the pain was originally localized but became diffuse with time. The severe pain prevents patients from performing usual activities, including walking and climbing stairs. Symptoms are relieved upon discontinuation of these oral bisphosphonates.
The FDA is especially concerned with the likelihood that this adverse reaction may be under-reported because the pain may be attributed to osteoporosis, the primary reason for which these oral bisphosphonates are prescribed, rather than identified as an adverse reaction to the medications. Patients reporting severe bone, joint, or muscle pain shortly after bisphosphonate therapy is initiated should be referred to their physician for evaluation. As with any medication or medical devices, adverse reactions should be reported to the FDA’s MedWatch program.
Endnotes
1 Wysowski DK, Chang JT. Alendronate and risedronate: reports of severe bone, joint, and muscle pain. Arch Intern Med 2005;165(3):346-7.
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Science in the News is a service by the American Dental Association (ADA) to present current information about science topics in the news. The ADA is a professional association of dentists committed to the public's oral health, ethics, science and professional advancement; leading a unified profession through initiatives in advocacy, education, research and the development of standards. As a science-based organization, the ADA's evaluation of the scientific evidence may change as more information becomes available. Your thoughts would be greatly appreciated.
Page Posted August 2006
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