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:

Ebola Crisis

REUTERS SHOWCASE

Ten Years On

Ten Years On

10 years on, tsunami warning stumbles at the "last mile".  Full Article 

Exit Polls

Exit Polls

BJP unlikely to form Jammu & Kashmir govt - polls.  Full Article 

Forceful Conversions

Forceful Conversions

BJP distances itself from religious conversions.  Full Article 

Hopeful Dhoni

Hopeful Dhoni

India's new vintage nearly ready, says Dhoni.  Full Article 

Photo

Fund Raising

Flipkart raises $700 million in fresh funding.   Full Article 

Reforms Push

Reforms Push

Modi may order insurance, coal reforms if vote delayed - officials.  Full Article 

Ali Hospitalized

Ali Hospitalized

Boxing great Muhammad Ali hospitalized with pneumonia.  Full Article 

Going International

Going International

Bollywood’s Priyanka Chopra sets sights on American TV.  Full Article 

India This Week

India This Week

Some of our best photos from this week.   Full Coverage 

Reuters India Mobile

Reuters India Mobile

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