Osteoporosis Drug Reclast Linked to Kidney Failure

Does Canada care more about its citizens' health than the U.S.? It sometimes looks that way.

The consumer group Public Citizen wants the U.S. Food and Drug Administration to do what Canada apparently did five months ago – tell Novartis to warn physicians and consumers about a dangerous link between a widely-used osteoporosis drug and serious renal toxicity, which can result in death.

In a letter to the FDA, Public Citizen's Health Research Group said the Canadian government reacted after learning of 265 cases of serious kidney impairment in patients using Aclasta (zoledronic acid). The drug is called Reclast in the U.S. and is identical to the Canadian version.

Five months later, the FDA has done nothing, said Public Citizen's Sidney Wolfe, M.D., in a letter to FDA Commissioner Margaret Hamburg, M.D.

“The Food and Drug Administration (FDA) has failed to take ... action requiring Novartis to alert physicians and patients in the United States about the growing evidence linking Reclast to this serious, life-threatening adverse event,” Wolfe said. “We therefore urge the FDA to immediately require that Novartis issue a similar “Dear Doctor Letter” to all physicians in the U.S.”

Reclast is given once a year for treatment of osteoporosis in men and postmeopausal women and once every two years for prevention of osteoporosis in postmenopausal women.

Wolfe noted that more than one million infusions of Aclasta had been administered worldwide as of October 2010. The 265 cases of renal impairment reported in Canada corresponds to a rate of about 20 cases per 100,000 patient-years of exposure. The FDA estimates that no more than 10 percent of adverse drug reactions are reported.

“Clearly, the current warnings and precautions in the FDA-approved label for Reclast about the risk of renal impairment are not sufficient for making physicians adequately aware of this serious, life-threatening renal toxicity associated with Reclast, the very reason that the Canadian government convinced the company to initiate the additional warnings,” Wolfe said..