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FDA: Exjade Use May Lead to Kidney Failure, Death

Novartis AG drug Exjade may cause kidney failure and death, according to a warning issued to healthcare providers by the Food and Drug Administration yesterday.

The FDA warning states that Novartis has received reports of kidney failure—at least eight of which proved fatal—in patients taking Exjade, a drug used to remove excess iron in patients with certain blood disorders.

Novartis noted that some of the patients had preexisting illnesses and blood disorders, but said it could not rule out the possible “contributory role” of Exjade.

In December 2006, Exjade's label was updated to include post-marketing reports of renal failure and other problems. A letter outlining those complications was sent to healthcare professionals earlier this month.

Exjade was approved in November 2005 for use in patients two and older who require regular blood transfusions or who have certain blood conditions. The drug helps remove excess iron build up that, if left untreated, can cause heart, liver, or other damage.

Since its approval, Exjade has been used to treat more than 13,000 patients.

(Source: http://online.wsj.com/)

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