FDA approves Baxter's intravenous nutritional supplement

Fri Oct 4, 2013 9:42pm IST

Related Topics

Stocks

   

(Reuters) - 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)

FILED UNDER:
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.

  • Most Popular
  • Most Shared

Smoking Habbits

Reuters Showcase

A Little Help

A Little Help

Researchers "buzz" the brain to speed up learning.  Video 

Disease Outbreak

Disease Outbreak

WHO says West African Ebola outbreak to last 2-4 months.  Full Article 

Healthy Food

Healthy Food

For teen girls, fruits and veggies linked to lower risk of breast condition.  Full Article 

Milk Effect

Milk Effect

Drinking milk may slow women's knee arthritis.  Full Article 

Rising Obesity

Rising Obesity

U.S. childhood obesity rates have increased since 1999: study.  Full Article 

Quality Check

Quality Check

Just because it's sweet and sticky doesn't mean it's 'honey': FDA.  Full Article 

Reuters India Mobile

Reuters India Mobile

Get the latest news on the go. Visit Reuters India on your mobile device.   Full Coverage