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Handmanw

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Handmanw

Re: Cardiologymd post# 285575

Saturday, 07/11/2020 11:02:49 PM

Saturday, July 11, 2020 11:02:49 PM

Post# of 426340
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.
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