Men's Osteoporosis Support Group

FDA alert regarding bisphosphonates and severe bone/joint/muscle pain

On 1/7/08 the FDA released an alert regarding bisphosponates taken for osteoporosis that included the following medications: Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa). I will post their entire alert below taken from http://www.fda.gov/cder/drug/infopage/bisphosphonates/default.htm.

FDA ALERT [1/7/2008] - FDA is highlighting the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics.

The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate. 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.

This severe musculoskeletal pain is in contrast to the acute phase response characterized by fever, chills, bone pain, myalgias, and arthralgias that sometimes accompanies initial administration of intravenous bisphosphonates and may occur with initial exposure to once-weekly or once-monthly doses of oral bisphosphonates. The symptoms related to the acute phase response tend to resolve within several days with continued drug use.

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.

EDITOR'S COMMENTS: This is the first I've heard of this problem with no external reports of anyone suffering from the described symptoms and I've seen nothing posted on PubMed. There should be more information following from the FDA on this topic and I'll post it as soon as I get it. In the mean time, should you feel you are having the severe bone, joint, and/or muscle pain, see your physician if you are taking a bisphosphonate.

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