Compassionate Use of Omegaven® for Critically Ill Infants with Liver Injury (H-23365)

Infants with parenteral nutrition associated liver disease (cholestasis) have a 35-70 percent mortality rate. Baylor College of Medicine and Texas Children's Hospital have been treating infants with Omegaven®, an intravenous lipid emulsion made of fish oil, since 2007. Because it is currently not approved by the Food and Drug Administration (FDA), the drug is administered under compassionate use to babies with liver disease due to receiving parenteral nutrition. Babies born prematurely or with complications are at an increased risk for liver disease because oftentimes they cannot tolerate oral or tube feeds, and must be nourished intravenously, which can over time cause liver damage. Omegaven®, which is 100 percent fish oil, was developed as an alternative to the traditionally used lipid emulsion which is only soybean oil. It provides vulnerable babies with important anti-inflammatory omega-3 fatty acids to heal their liver.

For more information, please contact Dr. Amy Hair at (832) 826-3719 or abhair@bcm.edu.