Omega-3 fatty acids
LOVAZA
What it isOmega-3 fatty acid preparations activating PPAR-alpha pathways; severe hypertriglyceridemia.
Why this oneUnlike purified icosapent ethyl, mixed EPA/DHA can raise LDL and lacks proven cardiovascular outcome benefit.
What limits itFishy eructation and GI upset impair adherence; watch for atrial fibrillation and additive bleeding.
FDA-approved for
- hypertriglyceridemia (2004)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Reduction of high triglycerides (adjunct to diet) | Adults | 4 g QD (4 caps) or 2 g BID (2 caps BID) | 4 g/day | 4 g/day |
Renal Undefined
Hepatic Undefined
Instructions
- Swallow capsules whole — do not break open, crush, dissolve, or chew
- Administered with meals in clinical studies
- Start and continue an appropriate lipid-lowering diet
- Before starting: assess TG level and manage secondary causes (diabetes, hypothyroidism, medications)
Cautions
- May increase LDL-C — monitor LDL periodically
- Hepatic impairment: monitor ALT and AST periodically during therapy
- Use with caution in fish and/or shellfish allergy
- Possible increased recurrence of symptomatic atrial fibrillation/flutter in patients with paroxysmal or persistent AF, especially first 2-3 months; not indicated for AF/flutter
- Monitor TG levels periodically during therapy
Adverse reactions
- Most common (>3%, > placebo): eructation, dyspepsia, taste perversion
- Also: constipation, GI disorder, vomiting, increased ALT/AST, pruritus, rash
- Postmarketing: anaphylactic reaction, hemorrhagic diathesis, urticaria
Pregnancy Insufficient human data to identify drug-associated risk; animal studies showed no adverse reproductive/developmental effects at 5x MRHD
Lactation Omega-3 fatty acids (EPA/DHA) present in human milk (higher with supplementation); no data on infant effects or milk production — weigh benefit vs. risk
NO BOXED WARNINGS
Principal riskIt can RAISE LDL, unlike icosapent ethyl
Cost, est. cash$5–$150/month
Generic entry2014
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilityMyopathy/rhabdomyolysis and hepatotoxicity; interaction burden varies by agent.
Mechanism of action: Omega-3 fatty acids ballicule
