The Food and Drug Administration (FDA) has issued an update to the drug label for Reclast, an injection used to prevent or treat osteoporosis. The new warning is in regards to the risk of renal failure.
Reclast, generic name zoledronic acid, is a bisphosphonate that is used to treat or prevent osteoporosis in women who are in menopause and to increase bone mass in men with osteoporosis. The injection is given in a single dose every one to two years.
The FDA has recently received reports of patients experiencing kidney failure while taking Reclast. These patients reporting kidney failure either required dialysis or died from the complication.
While kidney failure is a rare condition in patients using Reclast, it is more likely to occur in those patients who have a history of or risk factors for kidney problems. Risk factors include an underlying moderate to severe renal impairment, use of kidney-damaging or diuretic medicines, and severe dehydration before or after receiving Reclast.
The risk of developing renal failure increases with age. Your doctor should screen you for any kidney problems prior to giving you Reclast. You should tell your doctor about any medications you are taking so that he or she can better identify whether these medications will adversely react with Reclast.
Earlier this year, Reclast was identified as a drug that is likely to cause a femur fracture in patients. The FDA has sent out a safety announcement warning patients about the risks bisphosphonates pose and is continuing to review data regarding the risk of femur fractures in patients.