FDA Warns Reclast may Cause Kidney Impairment

The FDA has approved an update of the drug label of Reclast due to new evidence showing that it may increase the risk of kidney failure.

The FDA has approved an update of the drug label of Reclast (zoledronic acid) due to new evidence showing that it may increase the risk of kidney failure. There have been a number of cases where acute renal failure occurred after a patient began taking Reclast; in these cases, kidney failure either led to necessary dialysis or death.

On the new updated label, the FDA warns that Reclast is not advised for patients with creatinine clearance below 35 mL/min or for patients with evidence of acute renal impairment. Additionally, the label includes a recommendation that health care professionals screen patients before prescribing Reclast so they can identify patients with elevated risk.

The Reclast Medication Guide for patients is also being updated, as the future guide will contain information about the risk of severe kidney problems. Further, a ‘Dear Health Care Provider’ letter will be sent by the manufacturer of Reclast to inform health care professionals about this risk.

Although zoledronic acid is also sold as the bone metastases treatment Zometa, the label changes only affect Reclast because renal toxicity is already addressed in the Zometa label.

In its statement, the FDA encouraged health care professionals and patients to report adverse events and side effects linked to the use of either of these drugs to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.