Pancreatic enzyme replacement therapy (PERT) is a crucial treatment for individuals suffering from exocrine pancreatic insufficiency (EPI), a condition where the pancreas fails to produce sufficient digestive enzymes. The enzymes—lipase, amylase, and protease—are essential for breaking down fats, carbohydrates, and proteins so the body can absorb nutrients. Over the decades, many unapproved pancreatic enzyme products were available, but in 2004, the FDA initiated a regulatory change to ensure consistent quality and dosage. This led to a 2010 deadline, after which only FDA-approved products could be legally marketed. Today, patients rely on these regulated prescription medications to manage their condition effectively and safely.
The FDA Mandate and Approved Pancreatic Enzymes
Before the FDA mandate, pancreatic enzyme products varied significantly in potency and quality, creating unpredictability in treatment outcomes for patients with EPI. The FDA's action addressed these inconsistencies, requiring manufacturers to demonstrate that their products were safe and effective through rigorous clinical trials. This landmark decision standardized the treatment landscape and allowed healthcare providers and patients to trust the reliability of prescribed PERT medications.
List of FDA Approved Pancreatic Enzymes (Pancrelipase)
All FDA-approved pancreatic enzyme products contain the same active ingredient: pancrelipase, a combination of lipase, amylase, and protease derived from porcine pancreases. The primary distinction between the products lies in their formulation, specific indications, and available strengths. Currently, the following prescription products are FDA approved for treating exocrine pancreatic insufficiency:
- Creon® (pancrelipase)
- Zenpep® (pancrelipase)
- Pancreaze® (pancrelipase)
- Pertzye® (pancrelipase)
- Viokace® (pancrelipase)
- Ultresa™ (pancrelipase) - Note: Ultresa was discontinued but is part of the historical list of FDA-approved products.
Key Differences in FDA Approved PERTs
While all approved products share the active ingredient, their formulations are designed to optimize delivery and effectiveness. Most pancrelipase products are manufactured with an enteric coating, which protects the enzymes from being destroyed by stomach acid and ensures they are released in the small intestine where they can aid digestion. Viokace® is a notable exception; it is a non-enteric-coated tablet that must be taken in conjunction with a proton pump inhibitor (PPI) to protect the enzymes from the stomach's acidic environment.
FDA Approved vs. Over-the-Counter Supplements
One of the most important distinctions for patients with EPI to understand is the difference between FDA-approved prescription PERT and over-the-counter (OTC) pancreatic enzyme supplements. Unlike prescription products, OTC supplements are not regulated by the FDA for potency or quality and may contain inconsistent and unverified enzyme levels. A patient requiring PERT to manage their medical condition should never substitute a prescription product with an OTC supplement. Relying on unapproved supplements can lead to inadequate digestion and continued malabsorption, risking poor nutritional status and other health complications.
Comparison of FDA-Approved Pancrelipase Products
| Feature | Creon® | Zenpep® | Pancreaze® | Viokace® | Pertzye® |
|---|---|---|---|---|---|
| Formulation | Enteric-coated capsule | Enteric-coated capsule | Enteric-coated capsule | Non-enteric-coated tablet | Enteric-coated capsule |
| Indication(s) | EPI due to CF, chronic pancreatitis, pancreatectomy, or other conditions | EPI due to CF or other conditions | EPI due to CF or other conditions | EPI due to chronic pancreatitis or pancreatectomy (adults only) | EPI due to CF or other conditions |
| Porcine Source | Yes | Yes | Yes | Yes | Yes |
| Requires PPI? | No | No | No | Yes | No |
Potential Risks and Considerations
While FDA-approved PERT is generally safe and effective, patients should be aware of potential risks. A serious but rare condition called fibrosing colonopathy has been linked to very high doses of pancreatic enzymes, particularly in patients with cystic fibrosis. It is crucial to follow a doctor's dosing instructions carefully to minimize this risk. Other considerations include potential allergic reactions in individuals with a porcine protein allergy, though this is uncommon. A doctor may also recommend monitoring for issues like gout, as PERT can increase uric acid levels.
Conclusion
Today's landscape for treating exocrine pancreatic insufficiency is grounded in the FDA's regulatory framework, which ensures the safety and consistency of approved pancreatic enzyme products. Patients can choose from several prescription-strength pancrelipase medications, including Creon, Zenpep, Pancreaze, Viokace, and Pertzye, all of which contain the essential digestive enzymes needed for proper nutrient absorption. The critical takeaway for anyone with pancreatic insufficiency is to rely solely on these FDA-regulated prescriptions and to avoid unregulated over-the-counter supplements, which lack the same quality assurance. By working closely with a healthcare provider to find the most suitable approved product and dose, patients can effectively manage their condition and improve their nutritional health. The Cystic Fibrosis Foundation provides additional clinical guidance on pancreatic enzyme therapy for patients with CF, a population often affected by EPI.
Medscape: What is the FDA approved pancreatic enzyme replacement therapy?
- Response: The FDA has approved several pancrelipase products for pancreatic enzyme replacement therapy, including Creon, Zenpep, Pancreaze, Viokace, and Pertzye. These products contain a standardized mixture of lipase, amylase, and protease to help with digestion.
FDA Action: What caused the FDA to mandate approval for pancreatic enzymes?
- Response: In 2004, the FDA mandated approval for pancreatic enzyme products because previous versions were marketed without formal regulation, leading to inconsistent potency and quality. This action was necessary to ensure patients received safe and effective medication.
OTC Warning: Are over-the-counter pancreatic enzyme supplements the same as the FDA-approved ones?
- Response: No, over-the-counter pancreatic enzyme supplements are not FDA-regulated and may have inconsistent and unverified enzyme levels. For therapeutic use, patients should only use FDA-approved, prescription-strength products to ensure consistent dosage and quality.
Viokace: Why does Viokace need to be taken with a proton pump inhibitor?
- Response: Viokace is a non-enteric-coated tablet, meaning it lacks the protective coating found on other pancrelipase products. It must be taken with a proton pump inhibitor (PPI) to reduce stomach acid, preventing the digestive enzymes from being destroyed before reaching the small intestine.
Fibrosing Colonopathy: What is fibrosing colonopathy, and how is it related to pancreatic enzymes?
- Response: Fibrosing colonopathy is a rare but serious bowel disorder linked to high doses of pancreatic enzymes, particularly in patients with cystic fibrosis. Healthcare providers emphasize careful dosing to minimize this risk.
Porcine Source: Do all FDA-approved pancreatic enzymes come from a porcine source?
- Response: Yes, all currently FDA-approved pancreatic enzyme products are derived from porcine (pig) sources. Patients with a porcine allergy should discuss alternative options with their doctor, though allergic reactions are rare.
Indications: Which conditions are treated with FDA-approved pancreatic enzymes?
- Response: FDA-approved pancreatic enzymes are indicated for treating exocrine pancreatic insufficiency (EPI) due to various conditions, including cystic fibrosis, chronic pancreatitis, and pancreatectomy (surgical removal of the pancreas).
