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Handmanw

07/11/20 11:02 PM

#285577 RE: Cardiologymd #285575

Cardio,

The dizziness AE is listed in the Patient Information Section of the Vascepa Package Insert. It's listed as a symptom that is commonly reported for A-Fib patients. So because there were report of Vascepa apparently causing A-Fib the patient they would possibly be a risk to experiencing dizziness. If a patient in the study did not report or experience A-Fib the dizziness AE would not be an issue. I went back and reviewed the entire PI.