Gattex Approved for Short Bowel Syndrome
FRIDAY, Dec. 21 -- Gattex (teduglutide) has been approved by the U.S. Food and Drug Administration to treat nutritional problems caused by short bowel syndrome, which results when the small and/or large intestine are surgically removed.
Extensive removal of the intestines can lead to poor absorption of fluids and nutrients, the FDA said Friday in a news release.
Gattex is a once-daily injection that helps improve intestinal absorption. Two other drugs, somatropin and glutamine, have been FDA-approved to help treat short bowel disorder.
People who take Gattex may be at increased risk of developing colon cancer, intestinal polyps, gallbladder disease, biliary tract disease or pancreatic disease, the agency said.
The drug was evaluated in two clinical studies and two extension studies. The most common side effects reported were abdominal pain, injection site reactions, nausea, headache and upper respiratory tract infection.
Gattex is marketed by NPS Pharmaceuticals, based in Bedminster, N.J.
The U.S. National Library of Medicine has more about short bowel syndrome.
Posted: December 2012