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FDA approved Fish Oil Omega 3 Fatty Acids Brand Names- EPANOVA | Lovaza | Omacor | Triklo
What are the FDA approved Fish Oil Omega 3 Fatty Acids
Fish oil omega 3 fatty acids are mixtures of ethyl esters or free fatty acids derived from fish oil primarily composed of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
These products are FDA approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe (500 mg/dl or greater) hypertriglyceridemia. The effect of fish oil, omega-3 fatty acids on the risk for pancreatitis or on cardiovascular morbidity and mortality has not been established.
Results from a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 254 adults with hypertriglyceridemia indicate simvastatin combined with the fish oil product Lovaza provides greater benefit to the lipid profile than simvastatin alone.
The NDA for the prescription-only formulation was submitted in 2000 after the use of this proprietary product in the GISSI-Prevention trial, which found significant reductions in the risk of total death (14%) and cardiovascular death (17%) in patients receiving n-3 polyunsaturated fatty acids (PUFA).
The prescription-only formulation of fish oil, omega-3 fatty acids was FDA-approved in November 2004.
Indications
- hypertriglyceridemia
For use as an adjunct to diet to reduce hypertriglyceridemia (i.e., defined as triglyceride blood concentrations 500 mg/dL or greater)
Side Effects
- abdominal pain
- anaphylactoid reactions
- arthralgia
- atrial fibrillation
- atrial flutter
- coagulopathy
- constipation
- diarrhea
- dysgeusia
- dyspepsia
- ecchymosis
- elevated hepatic enzymes
- epistaxis
- eructation
- fatigue
- hypercholesterolemia
- nausea
- pharyngitis
- prolonged bleeding time
- pruritus
- rash
- urticaria
- vomiting
Monitoring Parameters
- LFTs
- serum cholesterol profile
- serum triglycerides
Contraindications
- anticoagulant therapy
- atrial fibrillation
- breast-feeding
- fish hypersensitivity
- hypercholesterolemia
- pregnancy
- thrombolytic therapy
Interactions
There are no drug interactions associated with Fish Oil, Omega-3 Fatty Acids (FDA-approved) products.