FDA changes zoledronic acid warning label

The US Food and Drug Administration (FDA) has approved an update to the label for zoledronic acid when sold under the name Reclast.

The new label includes a warning about the risk of renal failure, which can occur in patients with a history of or risk factors for renal impairment. Several cases of acute renal failure requiring dialysis or ending in death after zoledronic acid infusion are what prompted the label change.

The revisions are being made to the Reclast label only, although zoledronic acid is also sold under the name Zometa. 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.

An FDA review in January 2009 identified 5 deaths from acute renal failure following Reclast infusion. Based on that review, the “Warnings and Precautions” section of the Reclast label was updated in March 2009 with a recommendation to monitor serum creatinine before each dose of Reclast.

The FDA continued to note reports of renal failure after the initial label revision. A follow-up review in April 2011 showed an additional 11 cases of fatal acute renal failure and 9 cases of renal injury requiring dialysis after Reclast infusion.

Based on these findings, the FDA concluded that several risk factors identified as promoting nephrotoxicity with the use of Reclast should be added to the label.

These 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 administered. The risk of developing renal failure in patients with underlying renal impairment also increases with age.

The revised label also updates the instructions for prescribing Reclast and monitoring patients. The label states that Reclast should not be used 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 Reclast to identify those who are at risk of kidney failure. Clinicians should also monitor renal function in patients who are receiving Reclast.

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

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