A San Antonio physician’s passion to save premature babies was instrumental in the Food and Drug Administration’s recent approval of Omegaven, a lifesaving fish oil treatment for babies with gastrointestinal complications.
A study, led by Cynthia Blanco, M.D., was published in the Journal of Pediatric Gastroenterology and Nutrition. It followed the outcomes of babies treated with fish oil in the neonatal intensive care unit at University Hospital. The study data provided some of the evidence the FDA considered for its approval of Omegaven in the United States last summer.
“Overall, since 2011, we have had more than 50 patients enrolled in our long-term study and their survival without liver transplant increased dramatically—to better than 90 percent,” she said.
Dr. Blanco and her team will now be continuing their efforts in writing the national guidelines for Omegaven
in the U.S.
Dr. Blanco is a professor of pediatrics and interim chief of the Division of Neonatology and holds the Greehey Family Foundation Chair in Neonatology Research. She also is medical director of the Neonatal Nutrition & Bone Institute at University Health System.
Omegaven is a fish oil-based solution used to provide nutrition to critically ill patients. It has been used in Canada, Australia and Europe, but was not previously approved for widespread use in the U.S.
The FDA’s approval of Omegaven is for pediatric patients with parenteral nutrition-associated cholestasis (PNAC), a liver condition caused by a reduction in the flow of bile from the liver into the small intestine.