WASHINGTON—The U.S. Food and Drug Administration (FDA) is warning that Novartis‘ osteoporosis drug Reclast (zoledronic acid) increases the risk of kidney failure.
The federal agency said that cases have been reported of acute renal failure requiring dialysis or having a fatal outcome following Reclast.
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.
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.
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 as well as in the Reclast label. Dose reductions for Zometa are provided for patients with renal impairment.
The FDA said healthcare professionals should 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.
