What are the possible risks of zoledronic acid (Reclast) for the treatment of osteoporosis?

Updated: Aug 27, 2020
  • Author: Monique Bethel, MD; Chief Editor: Herbert S Diamond, MD  more...
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In September 2011, the US Food and Drug Administration (FDA) updated the prescribing information for zoledronic acid to provide improved information regarding the risk of kidney failure. Acute renal failure requiring dialysis and fatal outcomes have been reported to the FDA following the use of zoledronic acid. The drug is contraindicated in patients with moderate to severe renal impairment (ie, creatinine clearance < 35 mL/min) or evidence of acute renal impairment. Risk for renal impairment is also increased by the following [136] :

  • Coadministration of zoledronic acid with nephrotoxic or diuretic medications
  • Severe dehydration before or after administration
  • Advanced patient age

In March 2012, the FDA made safety labeling changes for zoledronic acid to warn against atypical subtrochanteric and diaphyseal femoral fractures in patients who have received bisphosphonate therapy including zoledronic acid. Fractures occur with minimal or no trauma and may present as groin pain weeks to months after fracture [137]

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