Lipid-Lowering Agents Pregnancy: Available data from published case reports and the pharmacovigilance database in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes.

Icosapent Ethyl

Brand names: Vascepa

Icosapent ethyl is a purified ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA), used to reduce cardiovascular risk in high-risk patients with raised triglycerides who are on statin therapy.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 4 grams per day — either four 0.5 gram capsules twice daily, or two 1 gram capsules twice daily

Route: Oral, with food

Frequency: Twice daily with food

Assess lipid levels before initiating therapy. Identify other causes of high triglyceride levels (e.g. diabetes mellitus, hypothyroidism, or medicines) and manage as appropriate. Patients should engage in appropriate nutritional intake and physical activity before starting treatment and continue during treatment. Advise patients to swallow capsules whole — do not break open, crush, dissolve or chew. Available as 0.5 gram and 1 gram capsules. Paediatric: safety and effectiveness in paediatric patients have not been established — verify against a children's formulary.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Known hypersensitivity (e.g. anaphylactic reaction) to icosapent ethyl or any of its components

Side effects

Musculoskeletal pain
Peripheral oedema
Constipation
Gout
Atrial fibrillation / atrial flutter (increased risk, including hospitalisation)
Arthralgia and oropharyngeal pain (hypertriglyceridaemia trials)

Interactions

Anticoagulants and/or antiplatelet agents — some published studies with omega-3 fatty acids have shown prolongation of bleeding time; monitor for bleeding (risk of bleeding was greater in patients on concomitant aspirin, clopidogrel or warfarin)

Clinical monograph

How it works

Its precise cardioprotective mechanism is not fully established, but it lowers triglyceride levels and is thought to exert additional anti-inflammatory, antithrombotic and membrane-stabilising effects beyond triglyceride reduction.

Prescribing in practice

It is associated with an increased risk of atrial fibrillation or flutter and of bleeding, particularly when combined with antiplatelet or anticoagulant therapy, so patients should be monitored accordingly.
Unlike mixed fish-oil preparations it is a high-purity EPA-only product and is used as an adjunct to, not a replacement for, statin treatment.
Use caution in patients with known hypersensitivity to fish or shellfish.

Monitoring

Monitor triglyceride and lipid levels, and review for new palpitations or atrial fibrillation and for signs of bleeding.

Counselling the patient

Report palpitations or an irregular heartbeat.
Tell clinicians about any unusual bruising or bleeding, especially if you take blood thinners.
Continue your statin and take this as directed alongside it.

Evidence & guidelines

The REDUCE-IT trial demonstrated that icosapent ethyl reduced major cardiovascular events in statin-treated patients with elevated triglycerides.

Reference: REDUCE-IT trial NEJM 2018; 380(1):11-22; NICE TA805; MHRA approval 2021; ESC/EAS Lipid Guidelines 2019; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

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