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FDA Drug Safety Communication: New contraindication and updated warning on kidney impairment for Reclast (zoledronic acid)

Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary
References

 

Safety Announcement

[09-01-2011] The U.S. Food and Drug Administration (FDA) has approved an update to the drug label for Reclast (zoledronic acid) to better inform healthcare professionals and patients of the risk of kidney (renal) failure. Kidney failure is a rare, but serious, condition associated with the use of Reclast in patients with a history of or risk factors for renal impairment. Cases of acute renal failure requiring dialysis or having a fatal outcome following Reclast use have been reported to FDA.

 

Facts about Reclast (zoledronic acid)

Used to treat or prevent osteoporosis in women after menopause. Reclast helps reduce the chance of having a hip or spinal fracture (break). Used to increase bone mass in men with osteoporosis. Used to treat or prevent osteoporosis in either men or women who take corticosteroid medications for at least one year. Used to treat men and women who have Paget’s disease of the bone. Given as an intravenous infusion in a single dose, once every 1 to 2 years. The infusion time should be no less than 15 minutes. Marketed under the brand name Aclasta outside the United States.

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 label as well as in the Reclast label. Dose reductions for Zometa are provided for patients with renal impairment.

Risk factors for developing renal failure include underlying moderate to severe renal impairment, use of kidney-damaging (nephrotoxic) or diuretic medications at the same time as Reclast, or severe dehydration occurring before or after Reclast is given. The risk of developing renal failure in patients with underlying renal impairment also increases with age.

The revised drug label will enhance the safe use of Reclast by providing healthcare professionals updated instructions for prescribing and patient monitoring. The revised label states that Reclast should not be used (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. Healthcare professionals should also monitor renal function in patients who are receiving Reclast (see Additional Information for Healthcare Professionals below).

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.

 

Additional Information for Patients

• Kidney failure is a rare, but serious, side effect associated with the use of Reclast.
• Your healthcare professional will order a serum creatinine level (a blood test) before and after each dose of Reclast to assess how well your kidneys are functioning.
• If you have kidney disease, discuss the necessity of Reclast treatment with your healthcare professional. There may be other treatment choices available to you.
• Make sure your healthcare professional knows about all the medications you are taking. It is helpful to keep a list of all your current medications in your wallet or another location where it is easily retrieved.
• Report any side effects with Reclast to FDA’s MedWatch program using the information at the bottom of the page in the “Contact Us” box.

 

Additional Information for Healthcare Professionals

• Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment.
• Continue to screen patients prior to each administration of Reclast to identify those with underlying acute or chronic renal impairment, advanced age, or dehydration. Patients with underlying renal impairment appear to be at highest risk for kidney failure. Reclast should be used with caution in this population.
• The risk of acute renal failure may increase with underlying renal disease and dehydration secondary to fever, sepsis, gastrointestinal losses, diuretic therapy, etc. The risk of developing renal failure in patients with renal impairment also increases with age.
• Calculate creatinine clearance before each dose of Reclast. Interim monitoring of creatinine clearance should be performed after Reclast dosing in at-risk patients. Creatinine clearance should be calculated based on actual body weight using the Cockcroft-Gault formula.
• Report any adverse events with Reclast to FDA’s MedWatch program using the information at the bottom of the page in the “Contact Us” box

 

Data Summary

A January 2009 FDA post-market safety review identified five deaths from acute renal failure following Reclast infusion. Based on that review, the Warnings and Precautions section of the Reclast label was updated in March 2009, with a recommendation to monitor serum creatinine before each dose of Reclast and included reports of renal impairment from clinical studies. An FDA Drug Safety Newsletter article was also published in 2009 reporting the post-marketing cases of renal impairment and acute renal failure.

FDA continued to note reports of renal failure to the Agency’s Adverse Event Reporting System (AERS) after the March 2009 label revision. A follow-up review in April 2011 showed an additional 11 cases of fatal acute renal failure and nine cases of renal injury requiring dialysis after Reclast infusion.

Based on the available information provided in the AERS cases, FDA concluded that several risk factors identified as promoting nephrotoxicity with the use of Reclast should be added to the label. Appropriate selection of patients and patient monitoring by healthcare professionals can reduce the likelihood of adverse events occurring and help ensure the safe use of Reclast.

 

References

1. National Center for Biotechnology Information. U.S. National Library of Medicine. PubMed Health Diseases and Conditions Monograph Kidney Failure. Available at: http://www.nlm.nih.gov/medlineplus/kidneyfailure.html. Accessed July 10, 2011