Drug Safety Communication: Zoledronic Acid [Reclast] Associated with New Contraindication and Updated Warning on Kidney Impairment

Last Updated on September 2, 2011 by Joseph Gut – thasso

September 01, 2011 – Risk factors for developing renal failure include underlying moderate to severe renal impairment, use of kidney-damaging (nephrotoxic) or diuretic medications at the same time as Zoledronic Acid [Reclast], or severe dehydration occurring before or after Zoledronic Acid [Reclast] is given. The risk of developing renal failure in patients with underlying renal impairment also increases with age.

The American Food and Drug Administration (FDA) has now notified healthcare professionals and patients of an update to the drug label for Zoledronic Acid [Reclast] regarding the risk of kidney failure. Cases of acute renal failure requiring dialysis or having a fatal outcome following Zoledronic Acid [Reclast] use have been reported to FDA. The revised label states that Zoledronic Acid [Reclast] is contraindicated in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment. The label also recommends that healthcare professionals screen patients prior to administering Zoledronic Acid [Reclast] in order to identify at-risk patients.

The Zoledronic Acid [Reclast] Medication Guide for patients is being updated to contain information about the risk of severe kidney problems. In addition, the manufacturer of Zoledronic Acid [Reclast] will issue a Dear Healthcare Provider letter to inform healthcare professionals about this risk.

These labeling changes are being made to the Zoledronic Acid [Reclast] label only, although Zoledronic Acid, also sold as  [Zometa], is approved for treatment of cancer-related indications. Renal toxicity is already addressed in the Warnings and Precautions section of the [Zometa] label. Dose reductions for [Zometa] are provided for patients with renal impairment.

Recommendation:

Zoledronic Acid [Reclast] is contraindicated in patients with creatinine clearance less than 35 mL/min, or in patients with evidence of acute renal impairment. Healthcare professionals should screen patients prior to administering Zoledronic Acid [Reclast] in order to identify at-risk patients. Healthcare professionals should also monitor renal function in patients who are receiving Zoledronic Acid [Reclast].

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting the report online at www.fda.gov/MedWatch/report.htm. Alternatively, download the form or call +1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to +1-800-FDA-0178.

Read here the MedWatch safety alert, including links to the Drug Safety Communication, including a Data Summary, and prescribing information.

Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

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