This document is a European Medicines Agency (EMA) publication, specifically from the Pharmacovigilance Risk Assessment Committee (PRAC).
It details new safety information for several medicines, based on recommendations adopted in September 2025.
The document provides the exact wording that must be added to the official product information (the Summary of Product Characteristics for healthcare professionals and the Package Leaflet for patients) for the following drugs and their identified safety concerns:
- Dabrafenib & Trametinib (brands: Tafinlar, Mekinist, Finlee, Spexotras): Addition of tattoo-associated skin reactions as a potential side effect.
- Diazoxide: Addition of necrotising enterocolitis neonatal (a severe intestinal condition) as a risk for newborns, including warnings and monitoring advice.
- Dinutuximab beta (brand: Qarziba): Addition of atypical haemolytic uraemic syndrome (a serious blood/clotting disorder) as a potential side effect.
- Osimertinib (brand: Tagrisso): Addition of Hepatitis B virus reactivation as a risk, including recommendations for monitoring and management.
- Somatrogon (brand: Ngenia): Addition of lipoatrophy (localized fat loss) at the injection site, with advice to rotate injection sites to prevent it
In short, this is an official regulatory update mandating changes to drug labels to inform healthcare providers and patients about newly recognized risks.
