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In the October to December 2016 report by the FDA’s Adverse Event Reporting System (FAERS), ten drugs or classes have been added to the latest watch list of drugs with potential safety issues.
The report was released on 31st March 2017, and one of the drugs added to the list was IMBRUVICA® (ibrutinib) capsules for oral use for the treatment of Chronic Lymphocytic Leukemia (CLL). This is due to the occurrence of fatal and non-fatal Pneumocystis jirovecii pneumonia (PJP) infections occurring in patients treated with ibrutinib.
The “Warnings and Precautions” section of the IMBRUVICA® prescribing information has been updated accordingly to include PJP, and recommends that patients are “evaluated for fever and infections and treat appropriately.”
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