How determination made fish oil an FDA-approved medicine for babies
Posted on December 10, 2018 at 5:38 pm
Dr. Cynthia Blanco’s passion to save babies was the key driver in the recent approval of Omegaven, a lifesaving fish oil treatment for babies with gastrointestinal complications.
Blanco’s study followed the outcomes of babies treated with fish oil in the Neonatal Intensive Care Unit at University Hospital.
“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.
Omegaven is a fish oil-based solution that is 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 European formulation was available to U.S. doctors only on a case-by-case basis.
“I couldn’t continue to see these babies bleed to death without doing something about it,” Blanco said. So, after initial reports of Omegaven’s success came from Boston, where it initially was being tested, Dr. Blanco applied for an investigational new drug (IND) license to have ready access to Omegaven for babies who needed it.
It was not easy. University Health System’s pharmacy department had to obtain a special veterinary license to import the fish oil medication. University Health System also covered the cost of the medication because it was not FDA approved.
University Hospital’s NICU has been the only program in South Texas able to administer this potentially life-saving medication. The results have been outstanding.
Among the initial 13 preterm babies enrolled in Dr. Blanco’s study, all of their intestinal problems improved so that they could be discharged, none required transplants and none died. “And there were no significant side effects, such as high infection rates, increased bleeding or further liver injury from being on an IV for so long,” she said.
The University Hospital NICU study, published in the May 2017 edition of the Journal of Pediatric Gastroenterology and Nutrition, was part of the data the FDA considered as they granted approval for the medication in July. Omegaven is now approved for pediatric patients with parenteral nutrition-associated cholestasis, a liver condition caused by a reduction in the flow of bile from the liver into the small intestine.
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