September 01, 2011
SAFETY ALERT: Reclast Labeling Updated to Include New Contraindication and Updated WarningsThe FDA has notified healthcare professionals and patients of an update to the labeling for Reclast (zoledronic acid; Novartis) regarding the risk of kidney failure. Cases of acute renal failure requiring dialysis or having a fatal outcome following Reclast use have been reported to the FDA. The revised labeling states that Reclast is contraindicated in patients with creatinine clearance <35mL/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.
These labeling changes are being made to the Reclast labeling only, although zoledronic acid, also sold as Zometa (Novartis), is approved for the treatment of cancer-related indications. Renal toxicity is already addressed in the Warnings and Precautions section of the Zometa labeling. Dose reductions for Zometa are provided for patients with renal impairment.
Reclast is indicated for the treatment and prevention of osteoporosis as well as Paget's disease of bone.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm270464.htm.