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FDA Warns of Pain Associated with Osteoporosis Drugs

By Jane Markel on Jan 8th, 2008 in Health | Add story link to StumbleUpon

fda-warns-of-pain-associated-with-osteoporosis-drugs.jpgThere’s a new government warning about certain drugs prescribed for osteoporosis or other bone-thinning diseases. The Food & Drug Administration has issued an alert about possible incapacitating bone, joint, and/or muscle pain in patients taking bisphosphonates.

The list of medications includes: Fosamax, Didronel, Boniva, Aredia, Actonel, Skelid, Reclast and Zometa.

The FDA says 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.

The FDA recommends that 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.

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