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FDA Warns of Pain Associated with Bisphosphonates

Patients may develop severe musculoskeletal pain months or years after starting the drug

TUESDAY, Jan. 8 (HealthDay News) -- Patients taking bisphosphonates may develop severe and sometimes incapacitating musculoskeletal pain, according to a statement issued Jan. 7 by the U.S. Food and Drug Administration. Bisphosphonates are marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid and Zometa.

Severe bone, joint and/or muscle pain can occur within days, months or years of starting bisphosphonate treatment, the statement said. Pain is commonly reported in people over the age of 65, but the FDA recommends a review of a patient's medical and drug therapy history for signs of a temporal association between the onset of musculoskeletal pain and bisphosphonate use. Pain may resolve quickly, slowly or not at all following discontinuation of the drug, the FDA said.

The prescribing information for the drug warns of a potential association between bisphosphonates and severe musculoskeletal pain, but the FDA notes that this information may be overlooked by health care professionals. The musculoskeletal pain at issue should not be confused with the acute phase response to the drugs, the FDA states, which is characterized by fever, chills, bone pain, myalgias and arthralgias.

"Health care 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 FDA's statement said.

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