Reports Of Kidney Failure, Death Raise Concerns Over Exjade
In a warning to healthcare professionals yesterday, the Food and Drug Administration said that Novartis AG drug Exjade may cause acute renal failure and death.
Exjade is an FDA approved drug used to remove excess iron in patients two and older who must undergo regular blood transfusions or who have blood conditions that lead to iron buildup. The drug was approved in November 2005, and has since been used to treat over 13,000 patients.
Novartis post-marketing reports, however, show that the drug may cause kidney failure and death. The company said it has received reports of acute renal failure in patients treated with Exjade. Eight of those cases resulted in death.
Even though some of the patients who experienced kidney complications while taking Exjade had existing illnesses or blood disorders, Novartis acknowledged that Exjade’s role could not be excluded.
The drug’s label was updated last December to include information about kidney failure and complications reported in patients who were given Exjade. Earlier in May, Novartis sent a letter to medical professionals outlining the updated information.