The Food and Drug Administration (FDA) has approved Creon® (pancrelipase), a delayed-release pancreatic enzyme replacement product (PEP) designed to help patients with cystic fibrosis and exocrine pancreatic insufficiency (EPI) digest and absorb nutrients from foods. 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, and is currently the only FDA-approved PEP marketed in the United States.
Creon, which contains a mixture of digestive enzymes extracted from the pancreas of pigs, helps patients lacking the enzymes needed to digest fats, proteins, and sugars from food. It is approved for use in pediatric and adult patients. The FDA has approved the manufacturer’s (Solvay Pharmaceuticals) Risk Evaluation and Mitigation Strategy (REMS), including a Medication Guide that advises patients on risks associated with high doses of Creon and the theoretical risk of transmission of viral disease from pigs to humans.
Creon may be sprinkled on food, and instructions for dosing based on weight and age should be followed carefully. 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. Individuals, who are allergic to pork and pork products, suffer from gout or kidney disease, have difficulty swallowing, are pregnant or who plan to become pregnant, or are breast feeding, should discuss the use of Creon with their healthcare professional. Common side effects of Creon include flatulence, abdominal pain, headache, and dizziness.
The FDA’s Office of Compliance and Office of New Drugs within Center for Drug Evaluation and Research (CDER) worked with the manufacturer through the agency’s unapproved drugs initiative to help the company come into compliance with federal laws by obtaining FDA approval. The agency continues to encourage the manufacturers of all other unapproved pancreatic enzyme products (PEPs) to work with the agency to obtain market approval. All PEPs must obtain FDA approval by April 28, 2010, or be removed from the marketplace.