FDA approved Fish Oil Omega 3 Fatty Acids

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

  1. abdominal pain
  2. anaphylactoid reactions
  3. arthralgia
  4. atrial fibrillation
  5. atrial flutter
  6. coagulopathy
  7. constipation
  8. diarrhea
  9. dysgeusia
  10. dyspepsia
  11. ecchymosis
  12. elevated hepatic enzymes
  13. epistaxis
  14. eructation
  15. fatigue
  16. hypercholesterolemia
  17. nausea
  18. pharyngitis
  19. prolonged bleeding time
  20. pruritus
  21. rash
  22. urticaria
  23. 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.

15585

Sign up to receive the trending updates and tons of Health Tips

Join SeekhealthZ and never miss the latest health information

15856