The United States Food and Drug Administration (US FDA) has notified healthcare professionals and patients in the US of an update to the drug label for zoledronic acid (Reclast®) regarding the risk of kidney failure. The FDA has received reports of patients developing acute renal failure requiring dialysis or having a fatal outcome following use of the drug. 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 the drug in order to identify at-risk patients.

The labelling changes are being made to the Reclast label only, not the Zometa® brand of zoledronic acid, which is approved for treatment of cancer-related indications.

The Medicines and Healthcare products Regulatory Agency (MHRA) issued similar advice for Aclasta® in April 2010.

Further details can be found at the links below.