Prepopik Approved for Colonoscopy Preparation
TUESDAY, July 17 -- Prepopik (sodium picosulfate, magnesium oxide and citric acid) has been approved by the U.S. Food and Drug Administration for adults preparing for a colonoscopy, a diagnostic procedure to inspect the colon's inner lining.
The cleansing regimen consists of two packets of powder, each dissolved in water, to be taken at different times before a colonoscopy, the FDA said in a news release. Additional fluid intake is needed to prevent dehydration and electrolyte imbalance, the agency warned.
In two clinical studies involving about 1,200 adults preparing for a colonoscopy, the most common side effects of Prepopik included nausea, headache and vomiting.
As a condition of approval, maker Ferring Pharmaceuticals must conduct additional studies to evaluate the product's safety and effectiveness among children, the FDA said.
Ferring is based in Parsippany, N.J.
To learn more about colonoscopy, visit the National Digestive Diseases Information Clearinghouse.
Posted: July 2012