FDA

Omega-3-Acid Ethyl Esters

Approved 7 Apr 2014OralCapsule

The FDA lists this product in 15 strengths and forms.

Indications

Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG). Omega-3-acid ethyl esters capsules are a combination of ethyl esters of omega 3 fatty acids, principally eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG).

( 1 ) Limitations of Use: The effect of omega-3-acid ethyl esters on the risk for pancreatitis has not been determined. ( 1 ) The effect of omega-3-acid ethyl esters on cardiovascular mortality and morbidity has not been determined. ( 1 ) Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters and should continue this diet during treatment with omega-3-acid ethyl esters.

Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.

Limitations of Use: The effect of omega-3-acid ethyl esters on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters on cardiovascular mortality and morbidity has not been determined.

Contraindications

Omega-3-acid ethyl esters are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any of its components. Omega-3-acid ethyl esters are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any of its components. ( 4 )

Warnings and precautions

In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy. ( 5.1 ) Omega-3-acid ethyl esters may increase levels of LDL. Monitor LDL levels periodically during therapy. ( 5.1 ) Use with caution in patients with known hypersensitivity to fish and/or shellfish. ( 5.2 ) There is a possible association between omega-3-acid ethyl esters and more frequent recurrences of symptomatic atrial fibrillation or flutter in patients with paroxysmal or persistent atrial fibrillation, particularly within the first months of initiating therapy.

At a glance

Brand name: Omega-3-Acid Ethyl Esters
Route: Oral
Dosage form: Capsule
Applicant: GLW
Status: Prescription
FDA approval: 7 Apr 2014
Application: ANDA091028-001

Indications

Contraindications

Warnings and precautions

Pregnancy and breastfeeding

8.1Pregnancy Pregnancy Category C:

There are no adequate and well-controlled studies in pregnant women. It is unknown whether omega-3-acid ethyl esters can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.Omega-3-acid ethyl esters should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Animal Data Omega-3-acid ethyl esters have been shown to have an embryocidal effect in pregnant rats when given in doses resulting in exposures 7 times the recommended human dose of 4 grams per day based on a body surface area comparison.

In female rats given oral gavage doses of 100, 600, and 2,000 mg per kg per day beginning 2 weeks prior to mating and continuing through gestation and lactation, no adverse effects were observed in the high-dose group (5 times human systemic exposure following an oral dose of 4 grams per day based on body surface area comparison). In pregnant rats given oral gavage doses of 1,000, 3,000, and 6,000 mg per kg per day from gestation Day 6 through 15, no adverse effects were observed (14 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison).

In pregnant rats given oral gavage doses of 100, 600, and 2,000 mg per kg per day from gestation Day 14 through lactation Day 21, no adverse effects were seen at 2,000 mg per kg per day (5 times the human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison). However, decreased live births (20% reduction) and decreased survival to postnatal Day 4 (40% reduction) were observed in a dose-ranging study using higher doses of 3,000 mg per kg per day (7 times the human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison).

In pregnant rabbits given oral gavage doses of 375, 750, and 1,500 mg per kg per day from gestation Day 7 through 19, no findings were observed in the fetuses in groups given 375 mg per kg per day (2 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison). However, at higher doses, evidence of maternal toxicity was observed (4 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison).

Omega-3-Acid Ethyl Esters

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Omega-3-Acid Ethyl Esters

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Monitoring: Laboratory Tests

5.2Fish Allergy

Interactions

7.1Anticoagulants or Other Drugs Affecting Coagulation

Pregnancy and breastfeeding

8.1Pregnancy Pregnancy Category C:

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information