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Omega-3 Fatty Acids

Medically reviewed by Drugs.com. Last updated on Jul 6, 2020.

Pronunciation

(oh MEG a three FAT tee AS ids)

Index Terms

  • Docosahexaenoic Acid
  • Eicosapentaenoic Acid
  • Ethyl Esters of Omega-3 Fatty Acids
  • Fish Oil
  • Omega 3
  • Omega-3-Acid Ethyl Esters
  • P-OM3

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Dialyvite Omega-3 Concentrate: 600 mg

Lovaza: 1 g [contains soybean oil, tocopherol, dl-alpha]

Ocean Blue MiniCaps Omega-3: 350 mg [gluten free, lactose free, sugar free; contains fd&c red #40, fd&c yellow #10 (quinoline yellow)]

Omega Power: 1050 mg [gluten free, lactose free, sugar free; contains fd&c red #40, fd&c yellow #10 (quinoline yellow); vanilla flavor]

Omega-3 2100: 1050 mg [odorless; orange flavor]

Triklo: 1 g [DSC]

Generic: 300 mg, 500 mg, 1000 mg, 1 g

Capsule, Oral [preservative free]:

Fish Oil Concentrate: 1000 mg [gluten free, lactose free, milk free, no artificial color(s), no artificial flavor(s), no artificial sweetener, sodium free, starch free, sugar free, wheat free, yeast free]

Maximum Red Krill: 300 mg [gluten free; contains soybean oil]

Omega-3 Fish Oil Ex St: 880 mg [gluten free]

Salmon Oil-1000: 200 mg [corn free, rye free, starch free, sugar free, wheat free]

Sam-E.P.A.: 200-300 MG [dye free]

Sea-Omega: 1000 mg [cholesterol free, corn free, gluten free, milk derivatives/products, no artificial color(s), no artificial flavor(s), sodium free, starch free, sugar free, yeast free; contains soybeans (glycine max)]

Generic: 200 mg, 1000 mg, 1200 mg

Capsule Delayed Release, Oral:

Odorless Coated Fish Oil: 1000 mg [gluten free, lactose free, milk free, no artificial color(s), no artificial flavor(s), no artificial sweetener, starch free, sugar free, wheat free, yeast free]

Pro Nutrients Omega 3: 332.5 mg

Generic: 1000 mg

Tablet Chewable, Oral:

Omega-3 IQ: 240 mg [DSC]

Brand Names: U.S.

  • Dialyvite Omega-3 Concentrate [OTC]
  • Fish Oil Concentrate [OTC]
  • Lovaza
  • Maximum Red Krill [OTC]
  • Ocean Blue MiniCaps Omega-3 [OTC]
  • Odorless Coated Fish Oil [OTC]
  • Omega Power [OTC]
  • Omega-3 2100 [OTC]
  • Omega-3 Fish Oil Ex St [OTC]
  • Omega-3 IQ [OTC] [DSC]
  • Pro Nutrients Omega 3 [OTC]
  • Salmon Oil-1000 [OTC]
  • Sam-E.P.A. [OTC]
  • Sea-Omega [OTC]
  • Triklo [DSC]

Pharmacologic Category

  • Antilipemic Agent, Omega-3 Fatty Acids

Pharmacology

Reduction in the hepatic production of triglyceride-rich very low-density lipoproteins. Possible cellular mechanisms include inhibition of acyl CoA:1,2 diacylglycerol acyltransferase, increased hepatic mitochondrial and peroxisomal beta-oxidation, and a reduction in the hepatic synthesis of triglycerides. The mechanisms contributing to reduction of cardiovascular events are not completely understood but are likely multi-factorial (eg, increased eicosapentaenoic acid [EPA] composition from carotid plaques, increased circulating EPA/arachidonic acid ratio, inhibition of platelet aggregation).

Absorption

Directly absorbed in the small intestine. Administration with a high-fat meal results in an increased overall exposure of total and free baseline-adjusted EPA by ~140% and 80%, respectively, compared to fasting conditions; a 40% increase in AUC occurred for baseline-adjusted free DHA.

Distribution

Vdss: EPA: ~88 L.

Metabolism

EPA and DHA are mainly oxidized in the liver similar to fatty acids derived from dietary sources. EPA: minor via CYP-450.

Time to Peak

Plasma: Following repeat dosing with low-fat meals for ~2 weeks (steady state): EPA: 5 to 8 hours; DHA: 5 to 9 hours.

Half-Life Elimination

EPA: ~37 hours; DHA: ~46 hours.

Protein Binding

EPA: >99%.

Special Populations: Gender

Females tended to have more uptake of EPA into serum phospholipids than males. The clinical significance of this is unknown.

Use: Labeled Indications

Dietary supplement: As dietary supplements for patients at early risk of coronary artery disease.

Note: Recommendations from the American Heart Association (AHA) state that patients without documented coronary heart disease (CHD) should eat a variety of fish, preferably oily fish (eg, salmon), at least twice a week, or daily in patients with documented CHD (AHA [Kris-Etherton 2002]).

Hypertriglyceridemia (Lovaza): As an adjunct to diet to reduce triglyceride levels in adults with severe (≥500 mg/dL) hypertriglyceridemia.

Note: The Endocrine Society recommends that omega-3 fatty acids may be considered for triglyceride levels >1,000 mg/dL and may be used alone or in combination with HMG-CoA reductase inhibitors (Berglund 2012). A number of OTC formulations containing omega-3 fatty acids are marketed as nutritional supplements; these do not have FDA-approved indications and may not contain the same amounts of the active ingredient.

Off Label Uses

IgA nephropathy

Data from a randomized, open-label, parallel-group clinical trial support the use of omega-3 fatty acids [Lovaza] in the treatment (ie, slowing rate of renal function loss) of IgA nephropathy [Donadio 2001]. A more recent meta-analysis does not confirm the efficacy for this indication, though it may likely be used for this indication [Liu 2012]. Additional trials may be necessary to further define the role of omega-3 fatty acids in the treatment of patients with IgA nephropathy.

Based on the Caring for Australasians with Renal Impairment guidelines early and prolonged treatment with fish oil may retard the rate of decline in renal function in adults with progressive IgA nephropathy; optimal dosing has yet to be established [CARI [Harris 2006]]. Routine use is currently not recommended (Laville 2004).

Contraindications

Hypersensitivity (eg, anaphylactic reaction) to omega-3 fatty acids or any component of formulation.

Dosing: Adult

Dietary supplement: 1 to 2 capsules 3 times daily. Note: Composition of OTC products may vary significantly.

Hypertriglyceridemia: Oral: Lovaza: 4 g (4 capsules) once daily or 2 g (2 capsules) twice daily.

IgA nephropathy (off-label use): Oral: Lovaza: 4 g (4 capsules) once daily (Donadio 2001).

Dosing: Geriatric

Refer to adult dosing.

Administration

Oral:

Lovaza: Administer with food. Administer whole; do not break, crush, dissolve, or chew.

Bariatric surgery: Capsule, delayed release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. Delayed-release capsule should be administered whole. Do not break, crush, dissolve, or chew. If safety and efficacy of fish oil can be effectively monitored, no change in formulation or administration is required after bariatric surgery; however, re-evaluation of need for omega-3 therapy after bariatric surgery is advised due to known improvements in cholesterol profile.

Dietary Considerations

Dietary modification is important in the control of severe hypertriglyceridemia. Maintain standard cholesterol-lowering diet during therapy.

Storage

Lovaza: Store at 25°C (77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F); do not freeze.

Drug Interactions

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): Omega-3 Fatty Acids may enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Anticoagulants: Omega-3 Fatty Acids may enhance the anticoagulant effect of Anticoagulants. Monitor therapy

Ibrutinib: Omega-3 Fatty Acids may enhance the antiplatelet effect of Ibrutinib. Monitor therapy

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Cardiovascular: Atrial fibrillation, atrial flutter

Gastrointestinal: Dysgeusia (4%), dyspepsia (3%), eructation (4%)

Frequency not defined:

Dermatologic: Pruritus, skin rash

Endocrine & metabolic: Increased LDL cholesterol

Gastrointestinal: Constipation, vomiting

Hepatic: Increased serum alanine aminotransferase, increased serum aspartate aminotransferase

Postmarketing:

Dermatologic: Urticaria

Hematologic & oncologic: Bleeding tendency disorder

Hypersensitivity: Anaphylaxis

Warnings/Precautions

Concerns related to adverse effects:

• Bleeding: Bleeding, including serious events, has been reported; risk may be increased with concomitant anticoagulant/antiplatelet use. Prolongation of bleeding time not exceeding normal limits has also been observed; use with caution in patients with coagulopathy. Monitor for signs and symptoms of bleeding.

• Fish allergy: Use with caution in patients with known allergy or sensitivity to fish and/or shellfish.

• Hepatic effects: ALT may increase without concurrent AST increase; periodically monitor hepatic transaminases in patients with hepatic impairment.

• Lipid effects: May increase LDL levels; periodically monitor LDL levels.

Disease-related concerns:

• Atrial fibrillation: Atrial fibrillation (AF) or flutter may occur; risk increased in patients with a history of AF or flutter and within the first 2 to 3 months of therapy.

• Conditions associated with abnormal lipids: Manage concurrent conditions (eg, diabetes, hypothyroidism, excessive alcohol intake) that may contribute to lipid abnormalities.

Other warnings/precautions:

• Appropriate use: Should be used as an adjunct to diet therapy and exercise. Secondary causes of hyperlipidemia should be ruled out prior to therapy. The effect, if any, of omega-3 fatty acids on the risk of pancreatitis or cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia is not known.

Monitoring Parameters

Triglycerides and other lipids (LDL-C) should be monitored at baseline and periodically. In patients with hepatic impairment, monitor hepatic transaminase levels, particularly ALT, periodically. Signs/symptoms of bleeding.

2013 ACC/AHA Blood Cholesterol Guideline recommendations (Stone 2013): Consider evaluation for GI disturbances and skin changes during therapy.

Pregnancy Considerations

Adequate intake of omega-3 fatty acids is recommended during pregnancy (IOM 2005; Nordgren 2017). Maternal use of supplements or dietary consumption of omega-3 fatty acids (containing eicosapentaenoic acid and docosahexaenoic acid) influences fetal concentrations (Büyükuslu 2017; Coletta 2010; Miles 2011).

Triglyceride concentrations increase during pregnancy as required for normal fetal development. When increases are greater than expected, supervised dietary interventions that include omega-3 fatty acids may be initiated. In women who develop very severe hypertriglyceridemia and are at risk for pancreatitis, use of prescription omega-3 fatty acid products may be considered (Avis 2009; Berglund 2012; Jacobson 2015; Wong 2015).

Patient Education

What is this drug used for?

All products:

• It is used to lower triglycerides.

• It may be given to you for other reasons. Talk with the doctor.

Icosapent ethyl:

• It is used with other cholesterol drugs to lower the risk of heart attack, stroke, some heart procedures, and a type of chest pain (unstable angina).

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burping

• Muscle pain

• Constipation

• Throat pain

• Change in taste

• Nausea

• Abdominal pain

• Joint pain

• Diarrhea

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Abnormal heartbeat

• Fast heartbeat

• Dizziness

• Passing out

• Shortness of breath

• Chest pain

• Bruising

• Bleeding

• Swelling in the arms or legs

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Frequently Asked Questions