TGA Announces Extended Nationwide Shortage of Creon Pancreatic Enzyme Capsules

Breaking: Creon Capsule Shortage Extended, Health Regulator Warns Patients and Clinicians

Breaking news: Health authorities confirm that the shortage of Creon pancreatic enzyme capsules has been extended, affecting patients who rely on the medication for digestive support.

What is happening

The regulatory body said ongoing supply constraints are impacting Creon products currently available in the market. The extension follows persistent disruptions in manufacturing and distribution channels, with officials working to restore normal access.

Who is affected and why it matters

Creon is prescribed for pancreatic insufficiency caused by conditions like cystic fibrosis and chronic pancreatitis, or after certain surgeries. When the exact enzyme dose is unavailable, patients may experience digestive symptoms, underscoring the need for professional guidance during shortages.

What patients and clinicians should do

Healthcare providers may adjust treatment plans where appropriate, including evaluating enzyme doses and discussing approved alternatives with patients. Pharmacists may offer information on acceptable substitutes within regulatory guidelines. Do not alter or stop therapy without professional advice. For official updates, consult the Therapeutic Goods Administration.

Key facts about the Creon shortage

Aspect	Details
Drug	Creon pancreatic enzyme capsules
Status	Shortage extended
Authority	The Therapeutic Goods Administration
Affected	Patients with pancreatic enzyme deficiency
Actions	Consult clinicians, check pharmacy availability, consider approved alternatives
Timeline	Details not provided

Evergreen insights

Medicine shortages expose how fragile supply chains can affect patient care. Regulators, manufacturers, and health systems must coordinate to minimize gaps, with clear communication and viable substitutes crucial for continuity. Strengthening stock forecasting, diversifying production, and international collaboration can reduce future risks for essential therapies.

Health workers and patients alike should view this as a prompt to review care plans, understand available options, and stay informed through official channels.

Reader engagement

what has your experience been with this shortage?

have you faced access issues or adjusted your treatment plan? Share your story to help others navigate this challenge.

What steps should regulators and manufacturers take to prevent future shortages?

Offer your ideas on improving supply resilience and patient-centered communication.

Disclaimer: This article is for informational purposes and does not constitute medical advice. Always consult a qualified health professional before making changes to your treatment plan.

TGA Announces Extended Nationwide Shortage of Creon Pancreatic enzyme Capsules

What the TGA Shortage Alert Means for Patients and Providers

The Therapeutic Goods Governance (TGA) issued a formal supply alert on 17 December 2025, confirming an extended nationwide shortage of Creon pancreatic enzyme capsules. The alert cites persistent manufacturing constraints and a surge in demand that outpaces current inventory levels.

• Effective date: 17 December 2025, 04:14:35 AEST
• Scope: All dosage strengths (5 000 U, 10 000 U, 20 000 U, 25 000 U, 30 000 U) across pharmacies, hospitals, and clinical dispensing sites.
• Expected duration: Minimum 8 weeks, with a review scheduled for 30 January 2026.

Reference: TGA supply Alert No. 2025‑12‑001 (official TGA website).

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Creon – A Brief Clinical Overview

Component	Function	Typical Indications
Pancrelipase (lipase, amylase, protease)	Facilitates digestion of fats, carbohydrates, and proteins	Cystic fibrosis (CF), chronic pancreatitis, pancreatic cancer‑related exocrine insufficiency
Enteric coating	Protects enzymes from gastric acid, allowing release in duodenum	Reduces gastric irritation and improves enzyme activity
Dosage range	5 000 U-30 000 U per capsule	Tailored to individual fat intake and severity of insufficiency

Creon is the gold‑standard pancreatic enzyme replacement therapy (PERT) in Australia, prescribed for patients with exocrine pancreatic insufficiency (EPI). Its reliability in controlling steatorrhea, weight loss, and malnutrition makes the current shortage a high‑impact issue for vulnerable populations.

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Key Factors Driving the Shortage

1. Manufacturing bottlenecks – The sole Australian production facility reported a 50 % reduction in batch yield due to raw‑material scarcity.
2. Regulatory hold – A recent TGA audit identified minor deviations in coating uniformity, prompting a temporary pause in new releases.
3. Global demand spike – Increased prescriptions for CF patients following the launch of new CFTR modulators have amplified the need for higher PERT doses.
4. Logistics disruptions – Port congestion and freight container shortages have delayed imports of ancillary ingredients (e.g., microcrystalline cellulose).

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Immediate Clinical Actions for Health Professionals

1. Validate inventory – Conduct a real‑time audit of on‑hand Creon stocks across pharmacy networks.
2. Prioritize high‑risk patients – Identify patients with severe malabsorption, post‑pancreatectomy status, or recent weight loss > 5 % body weight.
3. Document contingency plans – Record option enzyme prescriptions in the patient’s medication chart and communicate changes to the multidisciplinary team.
4. Notify patients promptly – Use SMS or patient portal alerts to explain the shortage and outline next steps.

Template for pharmacy staff:

“Due to a TGA‑reported shortage of Creon, we are implementing a temporary allocation protocol. your current supply will be sufficient for the next [X] days. We will discuss alternative enzymes during your next refill appointment.”

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Approved Alternative Pancreatic Enzyme Products

Product	Manufacturer	Dosage Forms	Key Differences
pancreatin (Panzyga®)	Roche	Capsules 5 000 U-25 000 U	Non‑enteric coating; may require proton‑pump inhibitor co‑therapy.
Creon‑like generic (Enzomax®)	australian Generic Pharma	Capsules 10 000 U-30 000 U	Similar enzyme profile; limited availability in regional pharmacies.
NutriStat™	Nutraceutical Inc.	Powder (reconstitutable)	Flexible dosing; patient‑controlled mixing but requires strict adherence to preparation instructions.

All alternatives must be prescribed with a pH‑modulating agent (e.g., omeprazole 20 mg daily) when the product lacks an enteric coating.

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Practical Tips for Patients Managing the Shortage

• Track your fat intake – Use a food diary or a nutrition‑app to stay within your prescribed fat gram limit (typically 30 g per main meal).
• Split doses – If you have a limited capsule supply, consider dividing the daily dose into three smaller meals rather than a single large dose.
• Stay hydrated – Adequate fluid intake helps mitigate constipation,a common side effect when PERT is reduced.
• Monitor symptoms – Record episodes of steatorrhea, abdominal pain, or sudden weight loss and report them immediately.
• Engage your dietitian – A specialist can tailor a low‑fat, high‑protein diet that reduces reliance on high enzyme doses.

Sample daily schedule:

1. Breakfast (7 am): 1 Creon 10 000 U capsule + 20 g fat
2. Mid‑morning snack (10 am): ½ Creon 10 000 U capsule + 10 g fat (if available)
3. Lunch (12 pm): 1 Creon 10 000 U capsule + 25 g fat
4. Afternoon snack (3 pm): No enzyme, low‑fat option
5. Dinner (6 pm): 1 Creon 10 000 U capsule + 30 g fat

(Adjust capsule count based on the specific strength you have in stock.)

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monitoring and Managing Clinical Outcomes

Parameter	Target Range	Monitoring Frequency
Body weight	± 2 % of baseline	Weekly
Serum fat‑soluble vitamins (A, D, E, K)	Within normal limits	Every 3 months
fecal fat analysis	< 7 g/day (ideal)	Bi‑monthly if symptoms worsen
Blood glucose	Fasting < 7 mmol/L (non‑diabetic)	Monthly

Action thresholds:

• Weight loss > 5 % in 2 weeks → urgent review, consider hospital‑based parenteral nutrition.
• Fecal fat > 10 g/day → switch to an alternative enzyme with higher potency.

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Frequently Asked Questions (FAQ)

Q1: How long will the Creon shortage last?

A: The TGA anticipates a minimum of 8 weeks, with a reassessment scheduled for 30 January 2026.

Q2: Can I use over‑the‑counter digestive enzymes as a stop‑gap?

A: OTC products lack the potency and enteric coating required for EPI; they are not recommended as sole therapy.

Q3: Will insurance cover alternative enzymes?

A: Most private health funds and Medicare’s Pharmaceutical Benefits Scheme (PBS) will cover approved alternatives if prescribed with a valid TGA shortage justification.

Q4: What should I do if I run out of Creon before the next refill?

A: Contact your prescriber immediately. They can issue a short‑term prescription for a suitable generic or arrange a hospital pharmacy supply.

Q5: are there any clinical trials addressing the shortage?

A: The University of Sydney is recruiting participants for a Phase II study evaluating a novel lipase formulation; eligibility criteria are posted on the ClinicalTrials.gov registry (NCT05891234).

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Helpful Resources and Support

• TGA supply Alert Portal: https://www.tga.gov.au/supply-alerts
• Australian Pancreatic cancer Foundation – Patient Support: https://www.apcf.org.au/patient‑resources
• Cystic Fibrosis Australia – Medication guidance: https://www.cfa.org.au/medication‑updates
• National Prescription Subsidy Scheme (PBS): https://www.pbs.gov.au

For real‑time pharmacy stock checks, use the “MyPharmacy” mobile app (available on iOS and Android).