F.D.A. Drug Safety Communication: New contraindication and updated warning on kidney impairment for Reclast

On September 1, 2011, the Food and Drug Administration (F.D.A.) updated the Reclast drug label to include a new warning on the increased risk of kidney (renal) failure for patients taking the medication.  This update comes after cases of acute renal failure were reported to the F.D.A. as a result of using Reclast. The new drug label provides healthcare providers with instructions on how to prescribe and monitor the use of Reclast in patients.

Reclast, also known as zoledronic acid or Zometa, is prescribed for the treatment or prevention of osteoporosis in women and men. Certain risk factors increase the likelihood of developing kidney (renal) failure as a result of taking Reclast. These risk factors include underlying renal impairment, use of nephrotoxic medications while on Reclast, or severe dehydration occurring before or after Reclast is administered. The risk of renal failure as associated with this drug also increases with age.

The change to the label follows a review conducted by the F.D.A. in April 2011 indicating eleven deaths from acute renal failure and nine cases of renal injury after the infusion of Reclast in these patients. After reviewing these reports received by the agency through its Adverse Reporting System, the F.D.A. decided to include the renal risk factors associated with Reclast on the drug label.

See the F.D.A. Drug Safety Communication:

See the new Reclast drug label:

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