Intravenous Fish Oil (Omegaven) Approved by FDA

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Intravenous Fish Oil (Omegaven) approved by FDA for use in total parenteral nutrition (TPN) in pediatric patients in the United States. Omegaven 10% Emulsion is a fish oil emulsion administered intravenously in patients who require parenteral nutrition lipid supplementation and cannot tolerate available lipid emulsions.

In 2001, Children’s Hospital Boston started doing research on TPN to find out what part of TPN was causing liver damage. Mark Puder, MD, a surgeon, and Kathleen Gura, PharmD, a pharmacist, collaborated on the research with other doctors at Children’s Hospital Boston. Through studies done on mice, they discovered that it was the lipid portion of the TPN that was causing the damage. But the fats contained in lipids are essential for the body, so they needed to find an alternative. Dr. Gura had previously used Intravenous Fish Oil (Omegaven), a lipid emulsion derived from fish oil that contains omega-3 fatty acids, to treat a patient with a soy allergy and severe fatty acid deficiency. From this experience she suggested they try Omegaven in their trials. The results were very promising.

This study concluded that Omegaven can be safely provided to children who are dependent on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD until the child can take adequate nutrition by mouth.

The use of Omegaven in children in the United States was until now experimental and under the FDA review. Its use was approved in Germany. In European studies, Omegaven has been associated with a reduction in psoriasis, when contrasted to administration of omega-6 fatty acid Lipoven. Omegaven has also been associated with reduced mortality and antibiotic use during hospital stays.

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