FDA issues alert for potential severe musculoskeletal pain related to osteoporosis drug treatment

The U.S. Food and Drug Administration has issued an alert highlighting the possibility of severe, and sometimes incapacitating, musculoskeletal pain in patients taking bisphosphonates.

Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between the drugs and severe musculoskeletal pain may be overlooked by health care professionals causing a delay in diagnosis, prolonging pain and/or impairment and necessitating the use of analgesics, the alert stated.

According to the alert, severe musculoskeletal pain may occur within days or even years after a patient begins taking a bisphosphonate drug. Some patients have reported complete symptom relief after discontinuing treatment, while others experience slow or incomplete pain resolution.

The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown, the alert noted.

The severe musculoskeletal pain highlighted in the FDA alert is in contrast to the acute phase response characterized by fever, chills, bone pain, myalgias and arthralgias that some patients may experience after the initial administration of either oral or intravenous bisphosphonates. Such acute phase symptoms tend to resolve within several days with continued drug use, the alert stated.

"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," the alert stated.

For more information:
To read the full FDA alert go to http://www.fda.gov/cder/drug/infopage/bisphosphonates/default.htm.