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NEW WARNING
Novartis has issued a “Dear Health Care Professional” letter about new safety information on the chelating agent deferasirox (Exjade). The drug is approved for treatment of chronic iron overload due to blood transfusions in patients over 2 years of age. Novartis has added to the package insert’s warnings section risk for acute renal failure, following reports of renal failure, including death, in patients receiving the drug. Novartis advises that the drug be used cautiously in patients with a preexisting renal condition and that the patient’s serum creatinine be checked before therapy and monitored at least monthly thereafter (weekly in high risk patients). Novartis has also added to the warnings section risk for cytopenias, following reports of various cytopenias in postmarketing studies. They advise regular monitoring of blood counts and interruption of therapy if levels fall. The adverse reactions section now also lists cytopenias, skin disorders, and hypersensitivity reactions including anaphylaxis and angioedema. Providers are encouraged to report any other adverse events to MedWatch.
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