This document is an official communication from the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC). It summarizes the outcomes of their safety review meeting held from September 29 to October 2, 2025.
The PRAC continuously monitors “safety signals”—which are early, potential indications of new side effects or new aspects of known side effects associated with a medicine.
Key Conclusions from the Meeting
The committee reviewed two specific safety signals and made the following recommendations:
1. Signal: Pancreatin – Risk of Infection from Viral Transmission
- What is it? Pancreatin is a medicine containing digestive enzymes, often used by patients with conditions like cystic fibrosis or chronic pancreatitis to aid digestion.
- The Safety Signal: A potential risk that the medicine could transmit viral infections. This is a concern because pancreatin is derived from animal (porcine) pancreatic tissue.
- PRAC Recommendation: The marketing authorization holders (MAHs – the pharmaceutical companies) for all listed brands of Pancreatin must provide supplementary information.
- Deadline for Action: The companies must submit this data by 10 December 2025.
2. Signal: Tirzepatide – Drug Interaction with Warfarin
- What is it? Tirzepatide is a medication used for type 2 diabetes and obesity (marketed as Mounjaro®/Zepbound®).
- The Safety Signal: Evidence suggests that Tirzepatide may decrease the effectiveness of warfarin (and similar blood thinners like coumarin derivatives). This is measured by a decrease in the International Normalised Ratio (INR), which could increase the risk of blood clots.
- PRAC Recommendation: The MAH (Eli Lilly) must provide supplementary information to further investigate this interaction.
- Deadline for Action: The company must submit this data by 7 January 2026.
What Happens Next?
- For the Companies (MAHs): They are legally required to provide the requested data by the specified deadlines. The PRAC will review this information and may decide on further actions, such as requiring updates to the product information (the Summary of Product Characteristics and package leaflet).
- For Healthcare Professionals & Patients:
- Pancreatin: Be aware of the ongoing investigation into the potential, though likely low, risk of viral transmission.
- Tirzepatide: It is crucial to monitor INR levels more closely in patients taking both Tirzepatide and warfarin (or similar blood thinners). Dose adjustments of the blood thinner may be necessary.
In summary, this document shows that the EU’s safety monitoring system is actively investigating two new potential risks. While no immediate label changes have been ordered, the regulatory process has been triggered to gather more data and ensure patient safety.
