Did you or someone you love suffer kidney failure after taking Reclast®?

Based on reports from the United States Food and Drug Administration (FDA), between April 2007 and April 2011, there were at least 44 reports of individuals suffering from renal (kidney) impairment and acute renal failure following use of the prescription drug Reclast®. Of these Reclast® users, at least 12 people required dialysis as treatment, and at least 18 people died. On September 1, 2011, relying upon these reports, the FDA required Novartis, the manufacturer of Reclast®, to strengthen the Reclast® warning label to better inform physicians and patients of the risk of kidney failure.

Previously, in 2009, the FDA published a Drug Safety Newsletter reporting that from April 2007 until February 17, 2009, 24 people suffered renal impairment and acute renal failure associated with the use of Reclast®. Of these initial 24 people, three required dialysis, and seven died. In March 2009, the Reclast® label was revised with a recommendation to monitor serum creatinine, an indicator of kidney function, before each dose of Reclast®. In April 2011, a follow up review of adverse reports following use of Reclast® revealed that nine more people had suffered renal (kidney) impairment requiring dialysis and an additional 11 people died from acute renal (kidney) failure.

What are the risks?

Reclast®, the trade name of zoledronic acid, is administered in 15-minute, once-yearly intravenous infusions. Among other uses, Reclast® is used to treat and prevent osteoporosis. It is also marketed by Novartis under the names Zometa, Zomera, and Aclasta, and it is not available in generic form.

Reclast® can be very dangerous if taken by a patient without healthy, functioning kidneys. The 2011 FDA warning recommends that Reclast® only be administered to patients with a creatinine clearance level greater than 35mL/min. Creatinine clearance levels are a measure of kidney function, and can be obtained by a doctor by testing samples of blood and urine.

The updated warning also identifies other factors that can increase a patient’s risk. These include advanced age, taking nephritic (kidney-related) medications, undergoing diuretic therapy, and experiencing dehydration either before or after the infusion. Patients with a history or indications of acute renal impairment should not take Reclast®.

Acute renal failure, the shut-down of the kidneys, has been observed in patients after only a single dose of Reclast®.

Do you believe you or a loved one has been injured by Reclast®? Goldberg & Osborne can help.

The law firm of Goldberg & Osborne is dedicated to helping injured people across the country and is currently accepting cases for Reclast® victims who have suffered from renal impairment or acute renal failure. For a FREE Reclast® case evaluation, please call us, toll-free, at 1-800-THE-EAGLE (1-800-843-3245) or submit an online case form here. If you choose to submit a case inquiry through this website, a legal assistant will call you to obtain information so our attorneys in Arizona can evaluate your potential claim.

Let Us Help You Seek Justice

Email us information about your potential claim, or give us a call 24/7 at 1-800-THE-EAGLE (1-800-843-3245) for a free, no obligation consultation.
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