The FDA said Exjade (deferasirox) is indicated for use in patients 2 years of age and older. The boxed warning will inform patients the drug might cause renal impairment, hepatic impairment and gastrointestinal hemorrhage. In some cases the reactions might be fatal.
The FDA said new language has also been added to the contraindications, warnings, precautions and drug interactions sections of the prescribing information for healthcare professionals.
Exjade is marketed by Novartis Oncology, part of the Novartis Pharmaceuticals Corp.
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