Reclast Kidney Failure Side Effects Added to Label in U.S.

A new warning about the risk of kidney problems from Reclast will be added to the osteoporosis drug in the United States, nearly a year after doctors in Canada were warned about the potential Reclast kidney failure side effects. 

The FDA issued a Reclast drug safety communication yesterday, warning that patients should be screened and then monitored for kidney problems if they are going to be prescribed Reclast.

According to an FDA analysis, there were at least 11 deaths due to acute kidney failure among Reclast users as of last April.

Those most vulnerable to kidney failure from Reclast include individuals who already have a history of kidney problems, those who were severely dehydrated just before or after being prescribed Reclast, and patients using kidney-damaging or diuretic drugs at the same time as they are given Reclast. The FDA also notes that Reclast kidney risks may increase with age.

The new label warning contraindicates Reclast in patients with acute renal (kidney) impairment or with creatinine clearance less than 35 mL/min. It also recommends patients be screened before being given Reclast and recommends their kidney functions be monitored after they are given the bone-strengthening drug.

Reclast (zoledronic acid) was developed by Novartis and approved by the FDA in 2007 for the treatment of postmenopausal osteoporosis and is also approved for the treatment of Paget’s disease. It is given as an injection once a year. It is also sold as Zometa, a monthly cancer drug.

The FDA warning comes almost a year after Novartis warned doctors in Canada about the risk of Reclast kidney damage. However, the same warnings were not provided by the drug maker in the United States. Novartis told Canadian doctors in a “Dear Health Care Professional” letter that it had received at least 265 reports of kidney damage with Reclast, which is sold as Aclasta in Canada.