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Pancrelipase Approval

The Food and Drug Administration (FDA) has approved delayed-release pancrelipase for adults and children with exocrine pancreatic insufficiency caused by cystic fibrosis, chronic pancreatitis, and other conditions. The drug will be marketed as Creon Delayed-Release Capsules.
   Creon is the only FDA-approved pancreatic enzyme product available in the United States, although several unapproved and untested dietary supplements are available. FDA officials note that pancreatic enzyme products aren't interchangeable and that patients should seek a prescriber's advice to determine the best product and dosage.
   In exocrine pancreatic insufficiency, the pancreas doesn't make enough digestive enzymes, which leaves the person unable to properly digest food and absorb nutrients. Pancrelipase contains enzymes that break down fats, proteins, and carbohydrates, allowing them to be absorbed by the body. The enzymes are extracted from pig pancreas.
   The most common adverse effects of pancrelipase (and of exocrine pancreatic insufficiency) are gas and upset stomach. Patients also have an increased risk of a rare bowel disorder called fibrosing colonopathy, which could cause intestinal stricture and require surgery. Because of the risk of fibrosing colonopathy, Creon will include a medication guide to explain the risks and help patients reduce them.


     
   

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