On May 22, 2007, the Food and Drug Administration (FDA) announced that Novartis’ drug Exjade, a drug for regular blood transfusion that removes excess iron in patients ages two and older, may cause acute kidney failure and possibly death.

Since the drug was approved in November 2005, there have been eight deaths associated with acute kidney failure, Novartis said in a statement. But most of the patients who died had multiple illnesses or were in advanced stages of blood disorders.

In addition, there were reports of patients developing cytopenia, another blood disorder that causes the body to stop producing or cut back on making blood cells, which could also be fatal.

Novartis said there is no direct relationship between Exjade and these episodes, but “a contributory role for Exjade cannot be excluded.” In December 2006, the drug’s label was updated to include the reports of kidney failure and other complications.

Patients who receive blood transfusions also receive red blood cells containing iron, which can build up in their systems and damage the heart, liver and other organs if untreated.

An FDA advisory panel recommended the approval of Exjade in September 2005. The panel also said it was concerned about the lack of safety data, and outside experts questioned how the drug would impact the liver.

“The diseases that we’re treating here are fatal if they’re not treated. You have a very sick patient group,” John Gilardi, Novartis spokesman, said. “This is not a new issue for Exjade.” Exjade has not been recalled at this time.

Sources: Jennifer Corbett Dooren, “FDA warns Novartis’s Exjade could cause kidney failure,” Wall Street Journal, May 23, 2007; Susan Heavey, “US FDA says deaths reported with Novartis’ Exjade,” Reuters, May 22, 2007; FDA Safety Information Alert, “Important information about Exjade (deferasirox) tablets for oral suspension,” May 14, 2007.