The U.S. Food and Drug Administration said on Friday it has approved Baxter International Inc's nutritional supplement Clinolipid, moving quickly to alleviate a drug shortage.
Clinolipid is an injectable source of calories and essential fatty acids designed for adults who cannot eat or drink. It contains a mixture of refined olive and soybean oils.
"The FDA has been very concerned about the short supply of injectable lipid emulsion products," said Dr. Donna Griebel, director of the agency's gastroenterology division. "Today's approval will help in the effort to resolve this shortage."
Clinolipid was compared in tests with soybean oil-based lipid emulsions. The agency said the omega-3 to omega-6 fatty acid ratio in Clinolipid has not been shown to improve patient outcomes more than other lipid emulsions.
The most common side effects of Clinolipid include nausea and vomiting, excess fat in the blood, high blood sugar, low levels of protein in the blood and abnormal liver function tests. The product is not approved for use in children.
(Reporting by Toni Clarke in Washington; Editing by Steve Orlofsky)