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Bill B

04/29/21 6:21 PM

#337694 RE: lizzy241 #337675

In clinical trials, Vascepa was associated with an increased risk of atrial fibrillation or atrial flutter (irregular heart rhythms) requiring hospitalization. The incidence of atrial fibrillation was greater among patients with a history of atrial fibrillation or atrial flutter. Vascepa was also associated with an increased risk of bleeding events. The incidence of bleeding was higher among patients who were also taking other medications that increase the risk of bleeding, such as aspirin, clopidogrel or warfarin at the same time.

https://www.fda.gov/news-events/press-announcements/fda-approves-use-drug-reduce-risk-cardiovascular-events-certain-adult-patient-groups#:~:text=Vascepa%20is%20taken%20orally.,atrial%20fibrillation%20or%20atrial%20flutter.

Triple88

04/29/21 8:05 PM

#337713 RE: lizzy241 #337675

AFib results in Reduce It Trial:
increase of 3.1% vs. 2.1%, P=0.004