cops Omega-3 polyunsaturated fatty acids Pregnancy and Breastfeeding Warnings Omega-3 polyunsaturated fatty acids is also known as: Animi-3, Animi-3 with Vitamin D, Cardio Omega Benefits, EPA Fish Oil, Fish Oil , Fish Oil Ultra, Flex Omega Benefits, Lovaza , MaxEPA, MegaKrill , Nature's Bounty Red Krill Oil , Omacor , Omega 3-6-9 Complex, Omega Essentials, Omega Essentials Basic, Omega-3, Omega-500, Prenatal DHA , Proepa, Sea-Omega, Sea-Omega 30, Sundown Naturals Triple Strength Red Krill Oil, Super-EPA, Triklo , Vayarin Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Drug Images Support Group Q & A Pricing & Coupons Omega-3 polyunsaturated fatty acids Pregnancy Warnings Animal studies showed embryocidal effects, decreased live births, and decreased neonatal survival at doses equivalent to 7 times the recommended human dose (of 4 grams/day); lower doses showed no adverse effects. Maternal toxicity occurred at 4 times the human dose (over 750 mg/kg/day) in animal studies. There are no controlled data in human pregnancy. Adequate omega-3 fatty acid intake during pregnancy may reduce preterm birth, increase birth length, weight, and head circumference, improve cognitive and visual development, and reduce risk of allergies. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Use is recommended only if clearly needed and the benefit outweighs the risk. AU TGA pregnancy category: B1 US FDA pregnancy category: C Comments: -There is no official RDA for omega-3 fatty acids during pregnancy, but the US Institute of Medicine and the Food and Nutrition Board suggest that 1400 mg per day should be adequate during lactation. -Pregnant women may not consume adequate amounts of omega-3 fatty acids from their diet due to recommendations to limit fish consumption to no more than twice weekly (due to mercury content of fish). See references Omega-3 polyunsaturated fatty acids Breastfeeding Warnings Use is not recommended. Safety has not been established. Excreted into human milk: Yes Comments: -Animal studies showed drug levels 6 to 14 times higher in milk than in plasma. -Effects on infants are unknown; use with caution. -Infant needs for docosahexaenoic acid (DHA) is approximately 70 to 80 mg per day. -There is no official RDA for omega-3 fatty acids during lactation, but the US Institute of Medicine and the Food and Nutrition Board suggest that 1300 mg per day should be adequate during lactation. See references References for pregnancy information "Product Information. Omega-3 D-3 Wellness Pack (omega-3 polyunsaturated fatty acids)." TMIG Inc, Marietta, GA. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015): Cerner Multum, Inc. "Australian Product Information." O 0 "Product Information. Lovaza (omega-3 polyunsaturated fatty acids)." GlaxoSmithKline, Research Triangle Park, NC. "Product Information. Omega-3-Acid Ethyl Esters (omega-3 polyunsaturated fatty acids)." Apotex Corporation, Weston, FL. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 References for breastfeeding information Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015): "Product Information. Omega-3 D-3 Wellness Pack (omega-3 polyunsaturated fatty acids)." TMIG Inc, Marietta, GA. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 "Product Information. Omega-3-Acid Ethyl Esters (omega-3 polyunsaturated fatty acids)." Apotex Corporation, Weston, FL. Print this page See Also... Krill Oil Consumer Information Pregnancy Support Group FDA Pregnancy Categories Medicine use during Pregnancy Medicine use while Breastfeeding Safe Medications during Breastfeeding Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist. Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Omega-3 polyunsaturated fatty acids Rating 27 User Reviews 7.3 /10 27 User Reviews 7.3 Rate it! Drug Class Nutraceutical products Related Questions & Answers Omega-3-Acid Ethyl Esters verses fish oil? Read more questions a really
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