Creon is the first FDA-approved delayed-release pancreatic enzyme replacement product to be marketed in the United States as a result of the agency’s "unapproved drugs" initiative. Creon, which contains a mixture of digestive enzymes extracted from pancreases of pigs, helps patients who lack the enzymes needed to digest fats, proteins, and sugars from food. Creon is approved for use in pediatric and adult patients.

The FDA had required Solvay Pharmaceuticals, the manufacturer of Creon, to submit a Risk Evaluation and Mitigation Strategy (REMS), which the agency has approved. The REMS includes a medication guide advising patients of risks associated with high doses of Creon and the theroretical risk of transmission of viral disease from pigs to patients. A rare bowel disorder, fibrosing colonopathy, can result from a patient’s use of Creon in high doses.

While this condition is serious and may require surgery, patients’ chances of having this condition may be reduced through adherence to dosing instructions stipulated in the labeling. The risks of a rare bowel disorder and viral transmission described in the medication guide are considered to be risks related to all porcine (pig)-derived pancreatic enzyme products, including Creon.

Instructions for dosing based on weight and age should be followed carefully. Creon may be sprinkled on food. Because Creon is a delayed-release drug, patients should never crush or chew the capsule, as this would cause an early release of the enzymes and a reduction in enzyme activity.

“The approval of Creon will allow patients access to an approved pancreatic enzyme replacement product that meets FDA standards for effectiveness, safety, and manufacturing consistency,” said Donna Griebel, M.D., director of the Division of Gastroenterology Products within FDA’s Center for Drug Evaluation and Research (CDER).

“Like other medically necessary drugs, the FDA is exercising its enforcement discretion while it works with the manufacturer toward gaining approval of these drugs,” said Deborah Autor, director, Office of Compliance, CDER. “FDA approval is critical, and the manufacturers of these products have a responsibility to the American public to ensure that patients have drugs that meet our standards of safety, effectiveness, quality, and labeling.”