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This drug safety and warning information is essential for anyone considering or currently using icosapent ethyl (Vascepa). Please take a moment to review the following points and consult your healthcare provider if you have any questions or concerns.

• Heart Rhythm Concerns: Using icosapent ethyl (Vascepa) may increase the risk of developing irregular heart rhythms, such as atrial fibrillation or atrial flutter. This condition may necessitate hospitalization. If you have a history of irregular heartbeat, heart disease, or diabetes with heart disease risk factors, inform your healthcare provider before starting this medication. Immediately contact your doctor if you experience symptoms like chest pain, dizziness, weakness, or shortness of breath.

• Allergic Reactions: Icosapent ethyl (Vascepa) is derived from fish oil and may cause allergic reactions in individuals with fish or shellfish allergies. It is crucial to disclose all allergies to your healthcare provider, particularly those related to fish, before beginning treatment. Discontinue use and seek medical help if you experience hives, swelling of the lips or tongue, or difficulty breathing.

• Increased Bleeding Risk: This medication can elevate the risk of bleeding, especially if you are also taking blood thinners like warfarin (Coumadin) or antiplatelet drugs such as aspirin and clopidogrel (Plavix). Promptly seek medical attention if you encounter issues such as uncontrolled bleeding, blood in urine or stool, coughing up blood, or feeling lightheaded or faint.

Please ensure to discuss your complete medical history and any other medications you are taking with your healthcare provider to safely use icosapent ethyl (Vascepa).

Common side effects:

• muscle, bone, or joint pain
• swelling in the arms, legs, hands, or feet
• constipation
• occasional gout
• irregular heart rhythms
• discomfort in the mouth and throat

Less common but important to monitor:

• diarrhea
• stomach pain
• pain in the arms, legs, hands, or feet

Serious side effects:

• significant heart rhythm disturbances
• severe allergic reactions
• serious bleeding issues

Icosapent ethyl, a prescription form of eicosapentaenoic acid (EPA), is used to lower triglyceride levels and reduce cardiovascular risk. While generally well-tolerated, it can interact with certain medications, particularly those affecting blood clotting.

When taken alongside anticoagulants (blood thinners) like Warfarin, or antiplatelet agents such as Aspirin and Clopidogrel, icosapent ethyl may increase the risk of bleeding. This is because omega-3 fatty acids, including EPA, can prolong bleeding time. Although studies have shown that this prolongation typically remains within normal limits and doesn't lead to significant bleeding episodes, it's important to monitor for signs of excessive bleeding. These signs include unusual bruising, prolonged bleeding from cuts, increased menstrual flow, or blood in urine or stools.

Additionally, icosapent ethyl may interact with certain beta-blockers and diuretics, potentially affecting their efficacy. If you're taking medications for blood pressure or heart conditions, discuss with your healthcare provider how icosapent ethyl might influence your treatment.

It's also worth noting that icosapent ethyl is derived from Fish Oil. If you have allergies to fish or shellfish, inform your doctor, as there may be a risk of allergic reactions.

To ensure safety and effectiveness, always inform your healthcare provider about all medications, supplements, and herbal products you're currently using before starting icosapent ethyl. Regular monitoring and open communication with your healthcare team can help manage potential interactions and maintain optimal health.