The signals include a new safety concern for Kounis syndrome with cefazolin and epiphysiolysis with erdafitinib and a rare renal adverse event with pegylated liposomal doxorubicin. In addition, PRAC requested supplementary information for several other signals, including strabismus with atropine eye drops, angioedema with darolutamide, DRESS syndrome with oxacillin, acute pancreatitis with vortioxetine,...
This is the 19th volume, 12th issue of the EPVC’s monthly newsletter, published in December 2025. It serves as an official communication from the Egyptian Drug Authority (EDA) to healthcare professionals, regulators, and the public regarding drug safety, pharmacovigilance activities, and regulatory updates in Egypt.
This document details the safety signals reviewed and the regulatory actions recommended by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) during its meeting in November 2025.
In a significant regulatory decision, the U.S. Food and Drug Administration (FDA) has approved an update to the label for the long-acting contraceptive Depo-Provera (medroxyprogesterone acetate). The change, finalized in December 2025, adds a formal warning about a potential increased risk of developing meningioma, a type of brain tumor. This action follows emerging scientific evidence...
This is the 19th volume, 11th issue of the EPVC’s monthly newsletter, published in November 2025. It serves as an official communication from the Egyptian Drug Authority (EDA) to healthcare professionals, regulators, and the public regarding drug safety, pharmacovigilance activities, and regulatory updates in Egypt.
Prescriber Update is a quarterly medical safety publication issued by Medsafe, the New Zealand Medicines and Medical Devices Safety Authority. It is intended for healthcare professionals to communicate emerging safety signals, drug risks, regulatory updates, and clinical advice.
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.
Advancing Medication Safety Through Knowledge and Vigilance
