The label for osteoporosis medication, <"http://www.yourlawyer.com/topics/overview/Reclast">Reclast (zoledronic acid), is being updated over its links to serious, adverse kidney reactions, the U.S. Food and Drug Administration (FDA) just announced. Reclast, a drug in the class bisphosphonates, has been linked to increased risks for kidney/renal failure. Reclast is marketed under the brand name Aclasta outside the United States.
Reclast is used to treat or prevent osteoporosis in women after menopause and helps reduce the chances of hip or spinal fracture; to increase bone mass in men with osteoporosis; to treat or prevent osteoporosis in either men or women who take corticosteroid medications for at least one year; and to treat men and women with Paget’s disease of the bone. Reclast is administered as an intravenous infusion in a single dose, once every 1 to 2 years. Infusion time should be no less than 15 minutes.
Although rare, kidney failure is a serious condition linked to the use of Reclast in patients with a history of, or risk factors for, renal impairment. Acute renal failure requiring dialysis or with a fatal outcome following Reclast use have been reported to FDA.
A January 2009 FDA post-market safety review identified 5 deaths from acute renal failure following Reclast infusion, which led to a revision to the “Warnings and Precautions” section of the Reclast label in March 2009, with a recommendation to monitor serum creatinine before each Reclast dose and including reports of renal impairment from clinical studies. An FDA Drug Safety Newsletter article was published in 2009 reporting the post-marketing cases of renal impairment and acute renal failure. The agency continued to note reports of renal failure to its Adverse Event Reporting System (AERS) after the label revision and an April 2011 follow-up review revealed 11 more cases of fatal acute renal failure and 9 cases of renal injury requiring dialysis after Reclast infusion.
The FDA concluded that some risks of increased nephrotoxicity with Reclast use should be added to the label. The change only affects Reclast, a zoledronic acid also sold as Zometa. Zometa is approved for cancer-related indications and renal toxicity is already addressed in its Warnings and Precautions section; Zometa dose reductions 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 prior to or following Reclast treatment. The risk for renal failure in patients with underlying renal impairment increases with age. According to the FDA, the revised Reclast label will enhance the safe use of Reclast by providing healthcare professionals with updated prescribing and patient monitoring instructions. Also, the revised label states that Reclast should not be usedâ€”is contraindicatedâ€”in patients with a creatinine clearance under 35 mL/min or in patients exhibiting symptoms consistent with acute renal impairment. The label recommends healthcare professionals screen patients before administering Reclast so at-risk patients can be identified.
Healthcare professionals are urged to monitor renal function in patients receiving Reclast; to continue screening patients before treatments; and to identify patients with underlying acute or chronic renal impairment, advanced age, or dehydration. Patients with underlying renal impairment are at greatest 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. Healthcare professionals are also advised to calculate creatinine clearance prior to each dose and interim creatinine clearance monitoring 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.
The Reclast Medication Guide for patients is being updated and the maker of Reclast will issue a Dear Healthcare Provider letter. Patients should be advised that kidney failure is a rare, but serious, side effect associated with Reclast use and that healthcare professionals will order a serum creatinine level blood test before and after each Reclast dose to monitor kidney functioning. Patients with kidney disease should discuss the necessity of Reclast treatment with their healthcare professionals; all patients should advise healthcare professionals about all medications they are taking.