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Questions and Answers: Delayed-Release Pancreatic Enzyme Product Receives FDA Approval

1. What did the Food and Drug Administration (FDA) announce today?

FDA announced the approval of Solvay Pharmaceutical’s Creon (pancrelipase) Delayed-Release Capsules, for adult and pediatric patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis and other conditions.  EPI is a lack of digestive enzymes made by the pancreas that results in the inability to properly digest food and absorb nutrients. 

2. Are there other FDA approved delayed-release pancreatic enzyme products (PEPs)?

Creon is the only currently available PEP approved by FDA for U.S. marketing.  One other delayed-release PEP, Cotazym, was approved by FDA, but is not marketed in the U.S.  Several other pancreatic enzyme products are currently on the market as unapproved products.  Most PEPs have been available for many years and have never undergone formal evaluation for effectiveness or safety.  When drug products lack required FDA approval, consumers and health care providers cannot be assured that those drugs are safe, effective, accurately labeled, and properly manufactured.  In April 2004, the agency announced that all PEP drug products are new drugs and described the conditions for continued marketing of these drug products (69 FR 23410).   

Please note that the different PEPs are not considered to be interchangeable.  Please discuss any change in PEP medication with your doctor to ensure you are receiving the proper dose. 

3. What are pancreatic enzyme products used for?

PEPs aid in the digestion of meals in patients who have diseases affecting their pancreatic enzyme function.  PEPs contain enzymes that break down fats, proteins, and carbohydrates (sugars) to allow absorption of these nutrients into the body.

4. What is Creon and how does it work?

Creon is a pancreatic enzyme product of porcine origin used to improve food digestion in people who cannot digest food properly because they have too little pancreatic enzyme function, which is also called exocrine pancreatic insufficiency (EPI).  Creon contains a mixture of digestive enzymes (including lipases, proteases, and amylases) extracted from pig pancreas.  Creon helps the body digest fats, proteins, and sugars from food so the body can absorb them. 

5. Who takes pancreatic enzyme products in the United States (U.S.)?

People of all ages with EPI due to cystic fibrosis, chronic pancreatitis, and other conditions take these products.   The estimated number of patients in the United States with EPI is over 200,000. 

6. What is Cystic Fibrosis (CF)?

Cystic fibrosis (CF) is a genetic disease affecting approximately 30,000 children and adults in the United States.  About 95% of patients with CF have EPI, and CF is the most common cause of EPI in children.  CF causes the body to produce abnormally thick, sticky mucus, due to the faulty transport of sodium and chloride (salt) within the cells that line organs such as the lungs and pancreas, to the outer surface of these cells.  The thick CF mucus also obstructs the pancreas, preventing digestive enzymes from reaching the intestines to help break down and digest food, and causes permanent damage to the pancreas.   

7. What is chronic pancreatitis?

Chronic pancreatitis is a recurrent inflammation of the pancreas that results in progressive damage to the pancreas and loss of pancreatic tissue.  Chronic pancreatitis results in abdominal pain, especially with eating, and a lack of sufficient pancreatic enzymes, resulting in a decreased ability to digest food.  Chronic pancreatitis affects approximately 200,000 people in the US, mainly adults 30 to 40 years of age and older. 

8. Are there any side effects with Creon?  

As with any drug product, there are potential side effects.  The most commonly reported side effects during Creon treatment include stomach problems (gas and upset stomach), although these are also symptoms of EPI and may be related to the underlying disease.  There is also a risk of having a rare bowel disorder called fibrosing colonopathy.  This condition is serious and may lead to intestinal stricture (narrowing of the digestive tract) that could require surgery.     

9. How will this serious risk be managed?

Creon is required to have a Risk Evaluation and Mitigation Strategy (REMS).  The REMS will include a Medication Guide, which will advise patients that high doses of Creon may increase their chance of having fibrosing colonopathy and that the risk of having this condition may be reduced by following the dosing instructions in the label, and taking Creon only as directed by your physician. 

The Medication Guide will also provide information that the risk of contracting a viral infection from porcine derived pancreatic enzyme products is theoretical and that no human illness has been reported. 

The risks of fibrosing colonopathy and viral transmission described in the Medication Guide are considered to be risks related to all porcine-derived pancreatic enzyme products including Creon.

10. What is the regulatory history of PEPS?

PEP products have been available in the U.S. since before the enactment of the Food, Drug, and Cosmetic Act in 1938 and the Drug Efficacy Study Implementation (DESI) requirements of 1962.  In April 2004, the agency announced that all PEP drug products are new drugs and described the conditions for continued marketing of these drug products.  In particular, FDA announced that manufacturers who wish to continue to market PEP drug products must submit new drug applications.  In April 2008, the agency published a guidance document to assist manufacturers in preparing and submitting NDAs.  The guidance indicated FDA would exercise enforcement discretion for firms who submitted INDs by April 28, 2008 and NDAs by April 28, 2009.  Creon is the first PEP approved by FDA for U.S. marketing under the process described in the guidance document.

11. Why is it important that all PEPs have approved NDAs?

PEPs are taken as maintenancemedications; therefore it is important to avoid both over- and under-treatment. This goal is best accomplished by having products with consistent quality, potency and stability.

Over the years, FDA has received reports of problems associated with these drugs.  Initially, the reports dealt with adverse events associated with high doses of enzymes leading to fibrosing colonopathy and strictures of the intestines (narrowing of the digestive tract).  More recently, the Agency has received a number of reports claiming that these drug products do not have the expected therapeutic effect (expected benefits of the medication).  There are many reasons why certain products may be subtherapeutic, including inactive ingredients or inadequate amounts of active drug in the capsule. 

12. Will dietary supplements that contain pancreatic enzymes remain on the market?

Yes. Under the law, FDA is not authorized to require premarket approval of products legally sold in the United States as dietary supplements.  The Agency’s action in this matter should have no impact on legally marketed dietary supplements.

13. How much will Creon cost?

Manufacturers establish prices for prescription drugs.  FDA has no input into or jurisdiction over drug pricing.

14. Will insurance companies pay for Creon?                                                          

The FDA also does not have jurisdiction over health insurance plans and the terms of coverage of medications.  You can contact your health insurance provider directly to discuss the extent of your coverage for Creon.

15. How can I report a serious side effect to FDA?

Health care professionals and consumers should report adverse events (side effects) or product quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.

16. Where can I get more information relating to PEPs?

Additional information can be obtained from the following organizations:

National Digestive Diseases Information Clearinghouse
2 Information Way
Bethesda, MD, 20892-3570
Phone: 1-800-891-5389 or (301) 654-3810
Fax: (301) 907-8906

National Library of Medicine, National Institutes of Health
MedlinePlus: Pancreatic Diseases

The Cystic Fibrosis Foundation 
6931 Arlington Road, #200
Bethesda, MD 20814
Telephone: 301-951-4422 or 1-800-344-4823 

FDA Drug Information at: 888-INFO-FDA (888-463-6332)

E-mail Drug Information at: druginfo@fda.hhs.gov

 

Contact FDA

1-800-332-1088
1-800-FDA-0178 Fax
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