Sept 2018 Enteric Coated Enzymes
July 2017 Longer Incubation Beneficial!
Dr. Anne Moesseler /Veterinary Nutritionist/ Univesrity Hannover, Hannover, Germany, EPI minipigs/Cystic Fibrosis studies
May 2017 CANINE GASTRIC LIPASE RESEARCH
February 2017: Amylase and Protease replacement enzymes needed in higher quantity than what was previously thought!
Dr. Anne Moesseler/ Veterinarian Researcher/ University of Hannover, Germany
December 2017 Diet EpiGenetics and Pancreatic Disease
on enzyme treatment for canine exocrine pancreatic efficiency:
For those who do not have access to porcine powdered enzymes but do have access to CREON and are interested in learning more about it (enteric coated capsules)….you might be interested in the following USA FDA regulations just approved CREON for human consumption on May 2009 for the use in the USA for in Exocrine Pancreatic Insufficiency http://www.fda.gov/
FDA NEWS RELEASE
|FOR IMMEDIATE RELEASE
May 7, 2009
FDA Approves Pancreatic Enzyme Replacement Product for Marketing in United States
Creon designed to help those with cystic fibrosis, others with exocrine pancreatic insufficiency
The U.S. Food and Drug Administration announced today that it has approved Creon (pancrelipase), a pancreatic enzyme replacement product designed to help patients with cystic fibrosis and others with 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.
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. Creon is approved for use in pediatric and adult patients.
The FDA had required the manufacturer of Creon to submit, and the agency has approved, a Risk Evaluation and Mitigation Strategy (REMS), which includes a Medication Guide, to advise patients on risks associated with high doses of Creon, and the theroretical risk of transmission of viral disease from pigs to patients. A rare bowel disorder, called fibrosing colonopathy, can result from a patient’s high-dose use of Creon. While this condition is serious and may require surgery, a patients’ chances of having this condition may be reduced through their adherence to dosing instructions 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 to have access to an approved pancreatic enzyme replacement product that meets FDA standards for effectiveness, safety, and manufacturing consistency,” said Donna Griebel, M.D., director, Division of Gastroenterology Products within FDA’s Center for Drug Evaluation and Research (CDER).
The FDA’s Office of Compliance and Office of New Drugs within CDER worked with Creon’s manufacturer, Solvay Pharmaceuticals, 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.
“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.”
People 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 breastfeeding, should discuss the use of Creon with their health care professional. Common side effects of Creon include flatulence (gassiness), abdominal pain, headache, and dizziness.
Creon and other pancreatic enzyme products are made from pancreatic organs of pigs used for food. There is a theoretical risk of contracting a viral infection from pig-derived medicines, but no human illness has been reported.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
- Regular Mail: use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 800-FDA-0178
- Phone: 800-FDA-1088
- For more information on Creon, visit FDA’s Web site.