THURSDAY, May 7, 2009 (HealthDay News) -- Creon (pancrelipase), a pancreatic enzyme replacement for people with cystic fibrosis and other conditions that involve exocrine pancreatic insufficiency, has been approved by the U.S. Food and Drug Administration for adults and children.
The drug is designed to help people with these conditions absorb dietary nutrients, including fats, proteins and sugars.
Creon is made from a mixture of digestive enzymes extracted from the pancreas of pigs, the FDA said in a news release. While the agency acknowledged a "theoretical risk of contracting a viral infection from pig-derived medicines," it said no cases of human illness stemming from the drug had been reported.
The maker of Creon, Solvay Pharmaceuticals, is required to submit both a risk evaluation assessment and medication guide, designed to advise users of the risks of pig-derived drugs, and about the risk of taking higher doses of Creon, the FDA said. These include the possibility of acquiring a rare bowel disorder called fibrosing colonopathy.
The agency said users should follow the drug's instructions carefully. Creon may be sprinkled on food, but the capsule should never be crushed or chewed, which would defeat its timed-release properties, the FDA said.
To learn more about this drug's approval, visit the FDA.