Prescription fish oil-based medications
Fish oil itself is available as a prescription, but the majority of fish oil products available via prescription are derivatives of fish oil. Such products are described elsewhere in this article. These preparations, with the purpose of treating or preventing medical disorder, are only available with a doctor's prescription. In the US, such prescriptions undergo the same Food and Drug Administration (FDA) regulatory requirements as other prescription medications, including with regard to both efficacy and safety.[61] Purity is also regulated by the FDA. The prescription fish oil derivative medicines differ from over-the-counter fish oil supplements.[62] Prescription fish oil is considered a safe and effective option to reduce triglycerides. There are various prescription fish oil products that have been approved and permitted by the FDA for decreasing triglyceride levels. Prescription fish oil products having DHA work by raising LDL-C levels to reduce triglycerides, like fibrates.[63] Heart experts advise that prescription fish oil helps in decreasing additional levels of blood fats. Prescription fish oils might only help when triglycerides reach a specific upper level.[64] Prescription fish oil pills, capsules and tablets have more omega-3 fatty acids than those which are non-prescription. The FDA regularly monitors prescription fish oil for standards like purity and for quality and safety.[65]
As of 2019, four fish oil-based prescription drugs have been approved in the United States for the treatment of hypertriglyceridemia,[8] namely:
- Epanova (omega-3 carboxylic acids) was approved on 23 April 2014.[66][67][68] Clinical trial on mixed dyslipidaemia (hypertriglyceridemia with hypocholesterolemia) started in 2014[69] found that it has no medical benefits, and the clinical trial was called off on 13 January 2019.[70] Although FDA-approved, Epanova is not available in any market.
- Lovaza (omega-3 acid ethyl esters) was approved on 10 November 2004.[71][72][73][74]
- Omtryg (omega-3 acid ethyl esters) was approved on 23 April 2014.[75][76][77]
- Vascepa (ethyl eicosapentaenoic acid; icosapent ethyl) was approved on 26 July 2012.[78][79][80] On 13 December 2019, the FDA also approved it as the first drug specifically "to reduce cardiovascular risk among patients with elevated triglyceride levels." Vascepa is not approved as a monotherapy for lowering TGs: it must be taken with a statin, per product labeling.[81]
Some fish-oil products are approved for parenteral nutrition:
- Omegaven, approved in July 2018, is indicated as a source of calories and fatty acids in children with parenteral nutrition-associated cholestasis (PNAC).[82][83][84]
- Smoflipid, approved in July 2016, 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.[85][86][87]
Dangers
A 2013 review concluded that the potential for adverse events among older adults taking fish oil "appear mild–moderate at worst and are unlikely to be of clinical significance".[88]
Maximum intake
The FDA recommends that consumers do not exceed more than 3 grams per day of EPA and DHA combined, with no more than 2 grams from a dietary supplement.[89] This is not the same as 3000 mg of fish oil. A 1000 mg pill typically has only 300 mg of omega-3; 10 such pills would equal 3000 mg of omega-3. According to the European Food Safety Authority's (EFSA) Panel on Dietetic Products, Nutrition and Allergies, supplementation of 5 grams of EPA and DHA combined does not pose a safety concern for adults.[90] A 1987 study found that healthy Greenlandic Inuit had an average intake of 5.7 grams of omega-3 EPA per day which had many effects including prolonged bleeding times, such as slower blood clotting.[91]
Research
Two 2021 systematic reviews and meta-analyses concluded that more than 1 g/d marine omega-3 fatty acids is associated with an increased risk of atrial fibrillation.[92][93]
Vitamins
The liver and liver products (such as cod liver oil) of fish and many animals (such as seals and whales) contain omega-3, but also the active form of vitamin A. At high levels, this form of the vitamin can be dangerous (Hypervitaminosis A).[94]
Toxic pollutants
Consumers of oily fish should be aware of the potential presence of heavy metals and fat-soluble pollutants like PCBs and dioxins, which are known to accumulate up the food chain. After extensive review, researchers from Harvard's School of Public Health in the Journal of the American Medical Association (2006) reported that the benefits of fish intake generally far outweigh the potential risks.
Fish oil supplements came under scrutiny in 2006, when the Food Standards Agency in the UK and the Food Safety Authority of Ireland reported polychlorinated biphenyl (PCB) levels that exceeded the European Union maximum limits in several fish oil brands,[95][96] which required temporary withdrawal of these brands. To address the concern over contaminated fish oil supplements, the International Fish Oil Standards (IFOS) Program, a third-party testing and accreditation program for fish oil products, was created by Nutrasource Diagnostics Inc. in Guelph, Ontario, Canada.[97]
A March 2010 lawsuit filed by a California environmental group claimed that eight brands of fish oil supplements contained excessive levels of PCBs, including CVS/pharmacy, Nature Made, Rite Aid, GNC, Solgar, Twinlab, Now Health, Omega Protein and Pharmavite. The majority of these products were either cod liver or shark liver oils. Those participating in the lawsuit claim that because the liver is the major filtering and detoxifying organ, PCB content may be higher in liver-based oils than in fish oil produced from the processing of whole fish.[98][99]
An analysis based on data from the Norwegian Women and Cancer Study (NOWAC) with regards to the dangers of persistent organic pollutants (POPs) in cod liver came to the conclusion that "in Norwegian women, fish liver consumption was not associated with an increased cancer risk in breast, uterus, or colon. In contrast, a decreased risk for total cancer was found."[100]
Microalgae oil is a vegetarian alternative to fish oil. Supplements produced from microalgae oil provide a balance of omega-3 fatty acids similar to fish oil, with a lower risk of pollutant exposure.[101]
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