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# FDA Reports New Vascepa Safety Concerns
- URL: https://www.fdaweb.com/fda-reports-new-vascepa-safety-concerns/
- Published: 2019-11-12T12:00:00.000Z
- Updated: 2026-09-14T15:52:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145484

An FDA briefing paper released in advance of the 11/14 Endocrinologic and Metabolic Diseases Advisory Committee discussion of Amarin’s Vascepa (icosapent ethyl) for an indication to reduce the risk of cardiovascular events as an adjunct to statin therapy in adults with elevated triglycerides and other cardiovascular disease risk factors describes two new safety signals that were not seen before. The [paper](https://www.fda.gov/media/132477/download?ref=fdaweb.com) says that more patients treated with Vascepa in the REDUCE-IT trial experienced atrial fibrillation or atrial flutter requiring hospitalization. And more patients treated with the drug also experienced a bleeding event such as gastrointestinal bleeding or contusions.

The agency’s medical reviewers noted that Vascepa treatment led to a 25% reduction in heart risks compared to placebo. However, they said, questions have remained about whether use of a mineral oil placebo inflated the drug’s reported benefit. The reviewers indicated they were not able to conclusively prove that hypothesis and said that in any case the impact of raised LDL levels would not have been sufficient to significantly change the clinical trial results.

Advisory committee members will be asked to **(1)** provide their interpretation of the clinical trial efficacy results; **(2)** discuss their level of concern about the new safety signals; and **(3)** discuss whether the efficacy and safety data from the trial provide substantial evidence of an indication for Vascepa to reduce the risk of cardiovascular events and if so, what populations beyond patients with established cardiovascular disease should be included in the indication.