Issue: February 2008
February 10, 2008
1 min read

FDA alert: Severe musculoskeletal pain a risk with bisphosphonates

Health care professionals, patients should report any events to the FDA’s MedWatch Adverse Event Reporting program.

Issue: February 2008
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Bisphosphonate use may be associated with severe and sometimes incapacitating bone, joint and musculoskeletal pain, according to a recent FDA alert.

Health care professionals should consider temporary or permanent discontinuation of the drug in patients who present with these symptoms, the FDA advised.

The agency cautioned that this pain is different from the acute phase response – typically characterized by fever, chills, bone pain, myalgias and arthralgias – that sometimes accompanies initial administration of both oral and intravenous bisphosphonates.

Prolonged pain, impairment

FDA-approved bisphosphonates already contain a warning of severe musculoskeletal pain in the precautions section of the prescribing information. However, this warning is often overlooked and can lead to delayed diagnosis and prolonged pain and impairment in patients.

Bisphosphonates are most commonly used to reduce fracture risk and increase bone mass in patients with osteoporosis. These drugs also are used to treat other conditions, such as bone turnover in patients with Paget’s disease and bone metastases in patients with cancer.

It is unknown when the onset of severe musculoskeletal pain occurs – within days, months or years. However, simply discontinuing the drug may not automatically stop the pain. According to the alert, some patients reported complete relief after stopping use, and some reported slow or incomplete resolution.

The risk factors and occurrence rates are unknown. According to the alert, severe musculoskeletal pain is more common in patients aged 65 and older. Thus, the FDA suggested health care professionals closely monitor all bisphosphonate users for severe musculoskeletal pain and other symptoms.

The alert includes alendronate (Fosamax, Fosamax + D, Merck); etidronate (Didronel, Proctor & Gamble); ibandronate (Boniva, Roche); pamidronate (Aredia, Novartis); risedronate (Actonel, Actonel + Ca, Proctor & Gamble); tiludronate (Skelid, Sanofi Aventis); and zoledronic acid (Reclast, Zometa, Novartis).

The FDA will continue to evaluate the safety of bisphosphonates. The agency has recommended that health care professionals and patients report adverse events to the FDA’s MedWatch Adverse Event Reporting program. – by Katie Kalvaitis