FDA Post-Marketing Safety Review Adds Liver Problems To Previous Reports Of Kidney Failure Associated With Exjade
(Posted by Tom Lamb at DrugInjuryWatch.com)
In the first edition of FDA Drug Safety Newsletter (Volume 1, Number 1), which was posted on the FDA's web site September 18, 2007, there is an article about the agency's post-marketing safety review of Exjade (deferasirox). This medication is an orally active chelating agent that removes excess iron in patients undergoing regular blood transfusions. Marketed in the U.S. by Novartis AG (NVS), Exjade was approved by the FDA for sale in 1995.
Adverse drug reaction reports associated with Exjade were the subject of a May 22, 2007 article in The Wall Street Journal, "FDA Warns Novartis's Exjade Could Cause Kidney Failure", which included this information:
In a May 14 letter to health-care professionals posted Tuesday to the FDA's Web site, Novartis said it received reports of kidney failure, some with a fatal outcome, in postmarketing reports of Exjade....
In a statement, Novartis said there were eight deaths associated with acute renal, or kidney, failure. More than 13,000 patients have been treated with Exjade since the drug was approved in November 2005.
In mid-September 2007 the FDA updated us on the Exjade safety situation, stating in the FDA Drug Safety Newsletter that the agency had received 115 reports of suspected adverse drug reactions (ADR) in association with Exjade use, including 17 deaths in adults.
In more detail, the FDA provided this additional information about the Exjade ADR reports it received from November 2005 through June 20, 2006:
- 108 of the reported Exjade cases were considered serious, with 74 events requiring hospitalization;
- 24 of the Exjade reports involved liver problems and included three reports of liver failure; those patients, however, apparently had a history of liver problems;
- 16 reports concerning Exjade use were associated with kidney problems; and,
- 15 reports to the FDA were associated with Exjade causing various blood disorders.
In closing-out its September 2007 Exjade update article, the FDA said that additional studies are being conducted in order for the agency and Novartis to "determine the longer-term benefits and risks of [Exjade (deferasirox)]."
Of course, we will continue to monitor and report on the safety profile of Exjade.