ANNEXA-1: Andexanet Alfa Associated with Harm in DOAC Reversal
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The Controversy of Andexanet Alfa
This chapter explores the contentious evaluation of andexanet alfa, focusing on its effects on patient outcomes, including an increase in thrombotic events. It emphasizes the need for transparency in clinical trials, financial implications, and the influence of pharmaceutical interests on medical literature.
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Background: In May of 2018, Andexanet alfa gained accelerated approval by the FDA for the reversal direct oral anticoagulants (DOACs) despite a lack of robust evidence for use. The 2022 AHA/ASA guidelines give the drug a level 2A recommendation and recommend it over the use of 4F-PCC (Greenberg 2022). FDA approval alongside guideline endorsement has ... 
