Fish oil

Fish oil is a component of SMOFLIPID, which was FDA approved in July 2016. It is indicated in adults as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

More commonly, fish oil refers to the omega-3-fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) . In general, dietary or pharmaceutical intake of these acids is primarily the only way to increase their levels in the human body where they are overall an essential element to dietary health as they have demonstrated abilities in minimizing or preventing hypertriglyceridemia when taken as an adjunct to a healthy diet .

Such fish oils are available in both non-prescription and prescription-only varieties at different concentrations. For many individuals, taking non-prescription fish oils as part of their multivitamin regimen is an effective way to supplement their diets with the healthy fatty acids. However, prescription-only fish oil products are sometimes prescribed for individuals who demonstrate severe (>= 500 mg/dL) hypertriglyceridemia .

Furthermore, a variety of studies regarding additional potential actions of fish oil omega-3-fatty acids EPA and DHA are ongoing. Such experimental actions include inflammation modulation, cardioprotective effects, the attenuation of oxidative stress, and more. Regardless, the specific mechanisms of action for these effects have yet to be formally elucidated.

Under FDA approval, fish oil pharmaceuticals are typically products consisting of a combination of the omega-3-fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and are indicated primarily as an adjunct to diet to reduce triglyceride levels in adult patients with severe (>=500 mg/dL) hypertriglyceridemia .

Under EMA approval, such fish oil pharmaceuticals comprised of virtually the same fish and fish oil derived omega-3-fatty acids EPA and DHA are indicated specifically for (a) adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (ie. statins, antiplatelet medicinal products, beta blockers, ACE inhibitors), and (b) as a supplement to diet when dietary measures alone are insufficient to produce an adequate response, particularly with type IV hypertriglyceridemia in monotherapy or type IIb/III in combination with statins, when control of triglycerides is insufficient . In addition, prescribing information for EMA approved fish oil pharmaceuticals are also indicated as an adjunct to diet to reduce very high (>=500 mg/dL) triglyceride levels in adult patients, much like similar FDA approved indications .