8/5/2023 0 Comments Gel capsule sizes![]() ![]() Vascepa is associated with an increased risk of bleeding. Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions to Vascepa and advise them to discontinue Vascepa and seek medical attention if any reactions occur. It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction to Vascepa. Vascepa contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fish. Potential for Allergic Reactions in Patients with Fish Allergy The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter. In a double-blind, placebo-controlled trial of 8,179 statin-treated subjects with established cardiovascular disease (CVD) or diabetes plus an additional risk factor for CVD, adjudicated atrial fibrillation or atrial flutter requiring hospitalization for 24 or more hours occurred in 127 (3%) patients treated with Vascepa compared to 84 (2%) patients receiving placebo. Vascepa is associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization. Warnings and Precautions Atrial Fibrillation/Flutter Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components.
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