FDA approves fish oil-based drug for heart attack and stroke prevention

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Late in 2019, the FDA approved a new use for icosapent ethyl (Vascepa), a drug that is a highly purified form of eicosapentaenoic acid (EPA), an omega-3 fatty acid found in fish.

The drug was originally approved in 2012 for treating people with very high levels of triglycerides, a type of fat in the blood. Now, icosapent ethyl is approved for people with triglyceride levels greater than or equal to 150 milligrams per deciliter who also have an elevated risk of cardiovascular disease despite taking the highest tolerable dose of a cholesterol-lowering statin. A large trial found that the drug decreases the risk of heart attack, stroke, and death from cardiac causes by 26% when compared with a placebo.

Icosapent ethyl appears to work by lowering the amount of triglycerides made by the body. But the cardiovascular-protective benefits also may arise from other mechanisms, such as reducing inflammation and making the blood less likely to clot. Side effects include potential increases in the risk of bleeding or more frequent atrial fibrillation (mostly in people that already have the arrhythmia).

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