Bisphosphonate Therapy Linked to Risk for Severe Musculoskeletal Pain

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Bisphosphonate Therapy Linked to Risk for Severe Musculoskeletal Pain

Yael Waknine

http://www.medscape.com/viewarticle/568424?sssdmh=dm1.331117 & src=nldne

January 8, 2008 — Temporary or permanent discontinuation of

bisphosphonate therapy should be considered in patients who present with

severe musculoskeletal pain, the US Food and Drug Administration (FDA)

warned healthcare professionals yesterday. Overlooking bisphosphonate

therapy as a causal factor may delay diagnosis, thereby prolonging pain

and/or impairment and the use of analgesics. In contrast with the

acute-phase response that sometimes accompanies initial exposure to

bisphosphonate therapy, some patients experience severe and sometimes

incapacitating bone, joint, and/or muscle pain that begins months or

years later.

The incidence rate and risk factors for this reaction remain unknown,

according to an alert sent from MedWatch, the FDA's safety information

and adverse event reporting program. Moreover, discontinuation of

therapy may not lead to complete relief — some patients have reported

slow or incomplete resolution of symptoms.

Over the next 6 months, the FDA will be evaluating reports of severe

musculoskeletal pain associated with bisphosphonate use. In the interim,

patients reporting these symptoms should be monitored, and alternative

causes for pain should be considered for those who do not experience a

lessening or resolution of symptoms after bisphosphonate withdrawal.

Bisphosphonates are indicated for the prevention and treatment of

osteoporosis and for treating hypercalcemia of malignancy and Paget's

disease. They also are beneficial in patients with multiple myeloma and

bone metastases from solid tumors.

Currently marketed oral bisphosphonates include risedronate sodium

tablets (Actonel and Actonel + Ca, Proctor & Gamble Pharmaceuticals,

Inc), alendronate sodium tablets (Fosamax and Fosamax + D, Merck &

Company, Inc), ibandronate sodium tablets (Boniva, Roche), etidronate

disodium tablets (Didronel, Proctor & Gamble), and tiludronate disodium

tablets (Skelid, sanofi-aventis US, LLC).

Injectable bisphosphonates include pamidronate disodium injection

(Aredia, Novartis Pharmaceuticals Corp) and zoledronic acid injection

(Reclast and Zometa, Novartis).

Adverse events related to bisphosphonate use should be reported to the

FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax

at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to

5600 Fishers Lane, Rockville, MD 20852-9787.

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