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IMBRUVICA® (ibrutinib) for Chronic Lymphocytic Leukemia added to watch list by FDA Adverse Event Reporting System

Apr 12, 2017

In the October to December 2016 report by the FDA’sAdverse 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 informationhas been updated accordingly to include PJP, and recommends that patients are “evaluated for fever and infections and treat appropriately.”

  1. U.S. Food and Drug Administration. Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): October - December 2016 Report. 2017 Mar 31. [Accessed 2017 Apr 11].