Healthy Skepticism Library item: 10167

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Publication type: news

US FDA says deaths reported with Novartis' Exjade
Reuters 2007 May 22
http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070522:MTFH36514_2007-05-22_16-31-47_N22436056&type=comktNews&rpc=44

Full text:

Severe kidney failure and some deaths have been reported in patients using Novartis AG’s iron overload drug Exjade, the U.S. Food and Drug Administration said on Tuesday.

The problems with Exjade, which removes excess iron from certain organs in patients receiving blood transfusions, were found in post-marketing reports for the drug, which was approved in late 2005, the agency said.

Most of the patients who died already had other complications and their illness was advanced, it added.

Patients using the drug reported various blood deficiencies known as cytopenias that in some cases also led to death, the FDA said in a statement.

“The relationship of these episodes to treatment with Exjade is uncertain,” the agency said, adding that most patients already had disorders often linked to bone marrow failure.

Other complications, including blood vessel inflammation, hives and hypersensitivity, were also reported.

The FDA said Novartis has already included the new concerns on the drug’s label. The company has also notified doctors, who should take steps to monitor at-risk patients, the FDA said.

Shares of Novartis on the New York Stock Exchange briefly fell more than 1 percent before recovering to be down just 11 cents at $55.36 in early afternoon trade.

A company representative did not immediately return a call seeking comment.

The FDA posted the statement on its Web site at http://www.fda.gov/medwatch/safety/2007/safety07.htm#Exjade