Oct 4 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
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.