Exjade kidney problems leads to FDA warning

The FDA and drug maker Novartis AG have issued an important warning about problems with Exjade which could lead to kidney failure or death.  Information about Exjade side effects were outlined in a May 14, 2007 letter to healthcare providers which was posted on the FDA website today.

>>INFORMATION:  FDA Warning of Exjade Problems

Exjade, manufactured by Novartis AG, is a drug that is given to patients undergoing regular blood transfusions to remove excess iron.  It was approved in November 2005, and over 13,000 patients have received the drug. 

Reports found cases of acute renal failure among individuals taking Exjade, and there have been at least 8 reported deaths.  The actual number of deaths caused by the drug could be significantly higher, as experts have previously estimated that the number of adverse side effects which are reported is often as low as 1% to 10% of all problems encountered.

Blood transfusions (transfusional ehmosiderosis) result in patients receiving red blood cells that contain iron.  In some patients, the iron can build up and lead to damage to the heart, liver or other organs if it is not properly treated.  Exjade is prescribed to remove excess iron, and it is approved for use in adults and children over the age of two.

The drug’s warning label has been updated to include information regarding Exjade problems with kidney failure, as well as indication of reported problems involving blood deficiencies, known as cytopenias, which can be fatal, blood vessel inflammation, hives and hypersensitivity.

Concerned patients should contact their physician.  Doctors were cautioned to monitor serum creatinine for those at an increased risk of complications, including those with pre-existing kidney problems, older patients, and those who are using medical products which reduce renal (kidney) function.

Further studies are being performed to evaluate the how the long term benefits compare to the risk of Exjade kidney problems.  If you, a friend or family member have been diagnosed with kidney failure, cytopenias or death, request a free consultation.