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Health Agencies Update
August 26, 2009

Zoledronic Acid Risks

JAMA. 2009;302(8):838. doi:10.1001/jama.2009.1171

Reports of renal problems in patients taking a once-yearly infusion of zoledronic acid for the treatment of osteoporosis, Paget disease, or for the prevention or treatment of glucocorticoid-induced osteoporosis have prompted new warnings from the US Food and Drug Administration (FDA) and the product's makers.

The FDA alerted physicians that it has received 24 reports of patients developing impaired renal function or acute renal failure after receiving an infusion of the drug, which is marketed as Reclast (http://www.fda.gov/downloads/Drugs/DrugSafety/DrugSafetyNewsletter/UCM168579.pdf). Of these patients, 18 required hospitalization and 7 died, according to the agency. More than half had medical conditions that put them at risk of kidney problems or were concurrently taking nephrotoxic medications. The drug's manufacturer has also updated the labeling of the drug to note such postmarketing reports.

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