This document is an official publication from the European Medicines Agency (EMA) detailing the safety recommendations made by its Pharmacovigilance Risk Assessment Committee (PRAC) following its meeting from 27–30 October 2025. It outlines newly identified safety “signals” (potential risks) associated with specific medicines and the regulatory actions required.
1. Purpose and Audience
- Purpose: To inform Marketing Authorisation Holders (MAHs), regulatory bodies, and healthcare professionals about new safety concerns and mandate updates to product information or request further study.
- Audience: Primarily pharmaceutical companies (MAHs), National Competent Authorities (NCAs) in EU member states, and the Committee for Medicinal Products for Human Use (CHMP).
2. Regulatory Context
- PRAC assesses safety signals from databases like EudraVigilance and scientific literature.
- Its recommendations are binding. MAHs must implement them within specified timelines.
- For Centrally Authorised Products (CAPs), recommendations are endorsed by the CHMP. For Nationally Authorised Products (NAPs), the Co-ordination Group (CMDh) is informed.
- MAHs are legally required to keep product information (SmPC and package leaflet) updated with current scientific knowledge.
3. Key Recommendations Summary
The recommendations are divided into three categories:
A. Updates to Product Information (Section 1)
Three medicines require immediate updates to their official product information (Summary of Product Characteristics and Package Leaflet). MAHs must submit a variation application within 2 months of publication.
- Bosutinib (used in leukemia)
- Signal: Cutaneous vasculitis (inflammation of skin blood vessels).
- Action: Add “Cutaneous vasculitis” as an Uncommon side effect (affects up to 1 in 100 people) in the product information.
- Datopotamab deruxtecan (“Datroway”, used in cancer)
- Signal: Anaphylactic reaction (severe, life-threatening allergy).
- Action:
- Add warnings to monitor patients closely during infusion and have emergency equipment ready.
- Add “Anaphylactic reaction” as a side effect with “frequency not known” to the product information.
- Mandate permanent discontinuation of treatment if a serious reaction occurs.
- Epcoritamab (“Tepkinly”, used in lymphoma)
- Signal: Hypogammaglobulinaemia (low levels of infection-fighting antibodies).
- Action:
- Add warnings to monitor immunoglobulin (Ig) levels before and during treatment.
- Add “Hypogammaglobulinaemia” as a Very Common side effect (affects more than 1 in 10 people) to the product information.
B. Requests for Supplementary Information (Section 2)
For two medicines, the PRAC requires the MAHs to provide a more detailed analysis in their next Periodic Safety Update Report (PSUR).
- Nemolizumab (for skin conditions): Further assess the signal of Erythema multiforme (a type of skin rash). PSUR due by 6 December 2025.
- Selumetinib (for cancer): Further assess the signal of Photosensitivity reaction. PSUR due by 18 December 2025.
C. Other Recommendations for Ongoing Monitoring (Section 3)
For two other substances, the PRAC has concluded that routine monitoring in future PSURs is sufficient for now, with no immediate action required.
- Adalimumab (for autoimmune diseases): Continue monitoring the signal of Morphoea (a skin hardening condition).
- Sulfasalazine (for arthritis and bowel disease): Continue monitoring the signal of Idiopathic intracranial hypertension (increased brain pressure).
4. Important Procedural Notes
- Each signal has a unique EPITT number (European Pharmacovigilance Issues Tracking Tool) for official tracking.
- A PRAC Rapporteur (a designated expert from a member state) leads the assessment for each signal.
- The document emphasizes that generic medicine manufacturers must comply with the same timelines as the innovator (originator) companies unless stated otherwise.
Conclusion
This document is a critical output of the EU’s pharmacovigilance system. It demonstrates the proactive monitoring of medicine safety after they reach the market. The recommendations directly lead to updated warnings for healthcare professionals and patients, ensuring that the known risk profile of these medicines is accurate and complete. The required actions range from immediate label changes to further data collection, depending on the strength and urgency of the safety signal identified.
