WASHINGTON, May 23 (UPI) -- The U.S. Food and Drug Administration says it has received reports of kidney failure and deaths possibly associated with Exjade.
In a letter to health-care professionals posted to the FDA's Web site, Novartis said eight cases of acute renal failure were reported in patients treated with Exjade.
The drug removes excess iron in patients undergoing regular blood transfusions, The Wall Street Journal said Wednesday. More than 13,000 patients have been treated with the drug since it was approved in November 2005, the newspaper said.
The Novartis letter said "most of the fatalities occurred in patients with multiple co-morbidities and who were in advanced stages of their hematological disorders."
Novartis said that while the patients already had pre-existing blood disorders, "a contributory role for Exjade cannot be excluded."
