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Safety
The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.
Allergies
People with allergy or hypersensitivity to fish should avoid fish oil or omega-3 fatty acid products derived from fish. Skin rash has been reported rarely. People with allergy or hypersensitivity to nuts should avoid alpha linolenic acid or omega-3 fatty acid products that are derived from the types of nuts to which they react.
Side Effects and Warnings
The U.S. Food and Drug Administration classifies intake of up to 3 grams per day of omega-3 fatty acids from fish as GRAS (Generally Regarded as Safe). Caution may be warranted, however, in diabetic patients due to potential (albeit unlikely) increases in blood sugar levels, patients at risk of bleeding, or in those with high levels of low-density lipoprotein (LDL). Fish meat may contain methylmercury and caution is warranted in young children and pregnant/breastfeeding women.
Omega-3 fatty acids may increase the risk of bleeding, although there is little evidence of significant bleeding risk at lower doses. Very large intakes of fish oil/omega-3 fatty acids ("Eskimo" amounts) may increase the risk of hemorrhagic (bleeding) stroke. High doses have also been associated with nosebleed and blood in the urine. Fish oils appear to decrease platelet aggregation and prolong bleeding time, increase fibrinolysis (breaking down of blood clots), and may reduce von Willebrand factor.
Potentially harmful contaminants such as dioxins, methylmercury, and polychlorinated biphenyls (PCBs) are found in some species of fish. Methylmercury accumulates in fish meat more than in fish oil, and fish oil supplements appear to contain almost no mercury. Therefore, safety concerns apply to eating fish but likely not to ingesting fish oil supplements. Heavy metals are most harmful in young children and pregnant/nursing women.
Gastrointestinal upset is common with the use of fish oil supplements. Diarrhea may also occur, with potentially severe diarrhea at very high doses. There are also reports of increased burping, acid reflux/heartburn/indigestion, abdominal bloating, and abdominal pain. Fishy aftertaste is a common effect. Gastrointestinal side effects can be minimized if fish oils are taken with meals and if doses are started low and gradually increased.
Multiple human trials report small reductions in blood pressure with intake of omega-3 fatty acids. Reductions of 2-5 mmHg have been observed, and effects appear to be dose-responsive (higher doses have greater effects). DHA may have greater effects than EPA. Caution is warranted in patients with low blood pressure or in those taking blood-pressure lowering medications.
Although slight increases in fasting blood glucose levels have been noted in patients with type 2 ("adult onset") diabetes, the available scientific evidence suggests that there are no significant long-term effects of fish oil in patients with diabetes, including no changes in hemoglobin A 1c levels. Limited reports in the 1980s of increased insulin needs in diabetic patients taking long-term fish oils may be related to other dietary changes or weight gain.
Fish oil taken for many months may cause a deficiency of vitamin E, and therefore vitamin E is added to many commercial fish oil products. As a result, regular use of vitamin E-enriched products may lead to elevated levels of this fat-soluble vitamin. Fish liver oil contains the fat-soluble vitamins A and D, and therefore fish liver oil products (such as cod liver oil) may increase the risk of vitamin A or D toxicity.
Increases (worsening) in low-density lipoprotein levels ("bad cholesterol") by 5-10% are observed with intake of omega-3 fatty acids. Effects are dose-dependent.
Mild elevations in liver function tests (alanine aminotransferase) have been reported rarely.
Skin rashes have been reported rarely.
There are rare reports of mania in patients with bipolar disorder or major depression. Restlessness and formication (the sensation of ants crawling on the skin) have also been reported.
Pregnancy and Breastfeeding
Potentially harmful contaminants such as dioxins, methylmercury, and polychlorinated biphenyls (PCBs) are found in some species of fish, and may be harmful in pregnant/nursing women. Methylmercury accumulates in fish meat more than in fish oil, and fish oil supplements appear to contain almost no mercury. Therefore, these safety concerns apply to eating fish but likely not to ingesting fish oil supplements. However, unrefined fish oil preparations may contain pesticides.
It is not known if omega-3 fatty acid supplementation of women during pregnancy or breastfeeding is beneficial to infants. It has been suggested that high intake of omega-3 fatty acids during pregnancy, particularly DHA, may increase birth weight and gestational length (254). However, higher doses may not be advisable due to the potential risk of bleeding. Fatty acids are added to some infant formulas.
NS_patient-fishoil
Portions of this document last updated:Sept. 1, 2009
THE NATURAL STANDARD RESEARCH COLLABORATION
(www.naturalstandard.com)
