FDA Updates Labeling For RECLAST

RECLAST (active ingredient zoledronic acid) is a prescription medication manufactured by Novartis Pharmaceuticals Corporation for the treatment and prevention of postmenopausal osteoporosis.

On September 2, 2011, the U.S. Food and Drug Administration (FDA) issued a labeling update for Reclast to better warn prescribing health care providers and patients regarding the risk of renal (kidney) failure while using Reclast. Renal failure is associated with the use of Reclast in patients with a history of renal failure or with risk factors for renal failure such as underlying moderate to severe renal impairment, use of nephrotoxic or diuretic medications while simultaneously taking Reclast, and severe dehydration before or after using Reclast. The risk of developing renal failure in patients with underlying renal impairment increases with age. The FDA has received reports of patients on Reclast suffering acute renal failure requiring dialysis or resulting in death.

The labeling changes are related to Reclast only and not to Zometa, which is zoledronic acid that is approved to treat cancer-related indications.

The FDA recommends that prescribing health care providers be aware that Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment; patients should continue to be screened 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 and therefore Reclast should be used with caution with these patients); the risk of acute renal failure may increase with underlying renal disease and dehydration secondary to fever, sepsis, gastrointestinal losses, diuretic therapy, etc.; and, creatinine clearance should be calculated (based on actual body weight using the Cockcroft-Gault formula) before each dose of Reclast with interim monitoring of creatinine clearance after Reclast dosing in at-risk patients.


If you or a loved one suffered kidney injuries after taking Reclast, you may be entitled to compensation for your injuries and losses. Visit our website to be connected with medical malpractice lawyers in your local area who may be able to investigate your claim and represent you, if appropriate. Our toll free telephone number is 800-295-3959.

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This entry was posted on Tuesday, September 6th, 2011 at 11:23 am. Both comments and pings are currently closed.


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