Key result
A 60-year-old woman developed severe, reversible neurologic symptoms including imbalance, dizziness, diplopia, and confusion after starting apixaban, which recurred upon re-challenge.
Case Report (n=1)
No
This case report describes a rare, reversible, and re-challenge-confirmed neurologic adverse reaction to apixaban, highlighting the need for ongoing post-marketing surveillance of novel oral anticoagulants.
Post-marketing reporting of adverse drug events is essential for new medications, as pre-FDA approval studies lack sufficient subject numbers to detect signals for rare events. Prescriptions for the novel oral anticoagulant factor Xa inhibitors (rivaroxaban, apixaban, edoxaban) have equaled or exceeded those for vitamin K antagonists in many clinical settings requiring chronic anticoagulation, and those of injectable heparins for deep vein thrombosis prophylaxis. We report the case of a 60-year-old woman followed for permanent atrial fibrillation who was prescribed apixaban. She rapidly developed worsening neurologic symptoms of imbalance and non-vertiginous dizziness preventing her from walking, headache, diplopia, and confusion/disorientation. Her symptoms began to resolve after stopping the drug, with return to baseline function within 72 h. Unbeknownst to her cardiology care team, the patient chose to re-challenge herself with apixaban at the same dose, producing identical symptoms and again total symptom resolution within 24 h of drug discontinuation. When seen by her physician, her physical examination was unchanged from her pre-treatment baseline. Symptoms did not recur when switched to rivaroxaban therapy.
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Josyln et al. (2018) conducted a case report in Permanent atrial fibrillation (n=1). Apixaban was evaluated on Neurologic adverse reaction. A 60-year-old woman developed severe, reversible neurologic symptoms including imbalance, dizziness, diplopia, and confusion after starting apixaban, which recurred upon re-challenge.
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