First FDA approved prescription Omega 3 in free fatty acid form

Generic : Omega – 3 – carboxylic acids

Brand: Epanova

Company : AstraZeneca

Approval status : approved in May 2014

Indication : Hypertriglyceridemia

Triglycerides : are a type of lipid , found in blood and are an essential source of energy for the body. 

Serum triglyceride levels :

a.Optimal… less than 100 mg / dL. 

b. Normal… 101-150 mg / dL. 

c. Borderline… 150-199 mg / dL. 

d. High… 200-499 mg / dL. 

e. Very high… 500 mg/dL or higher.

Hypertriglyceridemia : means that a patient has too much fat in the blood and this leads to the severe health related complications and problems. Patients with hypertriglyceridemia are usually seen to have other medical conditions as well e.g. diabetes, hypertension etc.

Mechanism of action: inhibition of acyl CoA 1,2- diaceylglycerol acyltransferase may increase mitochondrial and peroxisomal beta oxidation in liver, which may cause a decrease in the hepatic lipogenesis and thus may cause an increase in the plasma lipoprotein lipase activity. 

Dosage : 2-4 g PO qDay. It may be taken with or without food. The capsule is to be swallowed whole and not to be crushed or chewed. 

Peak plasma time : 5-9 hours. 

Metabolism : mainly undergo oxidation in liver to fatty acids. 

Half life : 37 hours (EPA), 46 hours (DHA) 

Plasma clearance: 548mL/hr (EPA), 518mL/hr ( DHA). 

Pregnancy category : C. 

Contraindications and Warnings:

1. Hypersensitivity (e.g. anaphylaxis). People allergic to fish or shell fish are at higher risk of showing allergic reactions to this drug.

2. Patients with impaired hepatic activity should have their ALT and AST levels monitored periodically.

3. May increase LDL-C levels, so should be monitored periodically.

Drug interactions: prolonged bleeding time has been reported with Omega – 3 – fatty acids, so patients taking anticoagulants were eliminated from the clinical trials.

Cautions: effect on risk of pancreatitis and effect on cardiovascular mortality and morbidity has not been determined. 

Points to be told to the physician by the patient before taking Epanova

a. if have diabetes. 

b. if have liver problems.

c. if suffering from hypothyroidism. 

d. about fish allergy (if any).

e. pregnant or breast feeding.

Side effects : diarrhea, nausea, eructation, abdominal pain. 

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2 thoughts on “First FDA approved prescription Omega 3 in free fatty acid form

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