FDA Alert: Fatal Renal Failure Reported Following Use of Exjade

Drugmaker Novartis and the Food and Drug Administration are alerting healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the product labeling for Exjade, a drug used to treat chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.

Cases of acute renal failure, some which resulted in fatalities, have been documented following ingestion of Exjade. Most of the deaths reported were experienced by people with several co-morbidities and who were in later stages of their hematological disorders.

Additionally, there were post-marketing documentations of cytopenias, including agranulocytosis, neutropenia and thrombocytopenia in people given Exjade where some of the patients expired.

The relationship of these events to ingestion of Exjade is uncertain. Most of these people had preexisting hematologic disorders that are often linked to bone marrow failure. Additionally, cases of leukocytoclastic vasculitis, urticaria, and hypersensitivity reactions (including anaphylaxis and angioedema) were documented.

Healthcare professionals should vigilantly watch serum creatinine in people who are at increased risk of complications, having preexisting renal problems, are older, have co-morbid conditions, or are ingesting medicinal products that depress renal function. Blood counts should also be watched regularly and treatment should be stopped in those who develop unexplained cytopenia.

see also:

Antidiabetic Drugs Makers of AntiDiabetic Drugs Strengthen Warning on Heart Failure Risk
Heart Failure Risk Prompts Stronger Warning on Antidiabetic Drugs

Livriro3 Nationwide Recall of Liviro3, Product Marketed as a Dietary Supplement
Ebeck issues voluntary recall of Liviro3 due to traces of tadalafil

2007 Health Advisories Pre-made Colistimethate May Link to Cystic Fibrosis Patient's Death
Cystic Fibrosis Patient Dies After Using Pre-Mixed Colistimethate