The FDA has announced that it will revise the warning label on Reclast, warning patients about the risk of kidney failure. Reclast was approved by the FDA in 2007 for the treatment of postmenopausal osteoporosis and is also approved for the treatment of Paget’s disease. The change comes nearly a year after doctors in Canada warned about the potential Reclast kidney failure side effects. Novartis, the maker of Reclast, warned Canadian doctors that the risk of kidney damage is increased with the medication, however the warnings were not provided 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. The FDA recommends that patients using Reclast should be screened and then monitored for kidney problems.
Individuals with a history of kidney problems are the most susceptible to Reclast kidney failure side effects. Those suffering from dehydration before or after using Reclast and patients using diuretic drugs with Reclast may also be at an increased risk of kidney problems. The FDA also notes that Reclast kidney risks may increase with age.
The revised label warns Reclast patients of acute renal impairment and also recommends that patients be screened before being given Reclast and recommends that their kidney functions be monitored after they have been prescribed the osteoporosis medication.