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FDA Drug Safety Podcast for Healthcare Professionals: New contraindication and updated warning on kidney impairment for Reclast (zoledronic acid)

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Welcome, my name is Steve Jackson, a pharmacist in the Division of Drug Information.  On September 1, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that FDA has approved an update to the drug label for Reclast, active ingredient zoledronic acid, to better inform healthcare professionals and patients of the risk of renal failure. Renal failure is a rare, but serious, condition associated with the use of Reclast in patients with a history of or risk factors for renal impairment. Cases of acute renal failure requiring dialysis or having a fatal outcome following Reclast use have been reported to FDA. 

These labeling changes are being made to the 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 as well as in the Reclast label. Dose reductions for Zometa are provided for patients with renal impairment. 

Risk factors for developing renal failure include underlying moderate to severe renal impairment, use of nephrotoxic or diuretic medications at the same time as Reclast, or severe dehydration occurring before or after Reclast is given. The risk of developing renal failure in patients with underlying renal impairment also increases with age. 

The revised drug label will enhance the safe use of Reclast by providing healthcare professionals updated instructions for prescribing and patient monitoring. The revised label states that 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 Reclast in order to identify at-risk patients. Healthcare professionals should also monitor renal function in patients who are receiving Reclast.

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

At this time FDA recommends that Healthcare Professionals be aware that:

  1. Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment.
  2. Patients should continue to be screened prior to each administration of Reclast to identify those with underlying acute or chronic renal impairment, advanced age, or dehydration. Patients with underlying renal impairment appear to be at highest risk for kidney failure. Reclast should be used with caution in this population.
  3. The risk of acute renal failure may increase with underlying renal disease and dehydration secondary to fever, sepsis, gastrointestinal losses, diuretic therapy, etc. The risk of developing renal failure in patients with renal impairment also increases with age.
  4. Creatinine clearance should be calculated before each dose of Reclast. Interim monitoring of creatinine clearance should be performed after Reclast dosing in at-risk patients. Creatinine clearance should be calculated based on actual body weight using the Cockcroft-Gault formula.
  5. Adverse events with Reclast should be reported to FDA's MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information.  Please read the Drug Safety Communication for the complete Data Summary detailing this communication.  A link to this DSC can be found at www.fda.gov/Drugs/DrugSafety.   If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

 

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