The European Medicines Agency (EMA) has updated product information for the cancer drugs darolutamide and gemcitabine to include new safety warnings, following recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) at its 8-11 June 2026 meeting. The changes, published on 6 July 2026, add angioedema as a side effect for darolutamide and strengthen warnings about severe skin reactions for gemcitabine.
For darolutamide, used to treat prostate cancer, the summary of product characteristics and package leaflet will now list angioedema — swelling under the skin in areas such as the face, lips, tongue and throat — as a side effect with frequency "not known", based on spontaneous post-marketing reports. The update aims to alert healthcare professionals and patients to a potentially serious allergic reaction that may require immediate medical attention.
For gemcitabine, a chemotherapy drug, the PRAC recommended adding drug reaction with eosinophilia and systemic symptoms (DRESS) to the list of severe cutaneous adverse reactions already associated with the medicine. The updated wording in section 4.4 of the summary of product characteristics now explicitly names DRESS alongside Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. The text advises that if signs of a severe skin reaction appear, gemcitabine should be withdrawn immediately and not restarted. The package leaflet is also revised to include a warning for patients to seek medical attention if they develop symptoms of serious skin reactions.
The document notes that for gemcitabine, the wording may need to be adapted by marketing authorisation holders to individual products, taking into account existing wording in some nationally authorised products. The changes are part of routine pharmacovigilance signal detection and are expected to be implemented by marketing authorisation holders across the EU.
Patients and healthcare professionals will benefit from clearer warnings that may enable earlier recognition and management of these rare but serious adverse reactions. Marketing authorisation holders for gemcitabine may face administrative burden in adapting the wording to individual product licences. No major financial impact is anticipated, as the updates are standard safety label changes.