Spain’s AEMPS Publishes December 2025 Safety Bulletin

Spanish Agency of Medicines and Medical Devices (AEMPS) has released its Drug Safety Bulletin for December 2025, summarizing updated pharmacovigilance information for medicines marketed in Spain. The bulletin provides guidance for healthcare professionals, regulatory teams, and pharmaceutical companies on signal detection, risk management, and adverse drug reaction (ADR) reporting. (AEMPS Bulletin)

Key Safety Updates

Pediatric Paracetamol Overdose – Serious ADRs, including liver toxicity, were reported due to dosing errors. Clinicians should carefully verify concentrations and correct dosing according to weight.

Tranexamic Acid Intrathecal Errors – Accidental intrathecal administration of intravenous tranexamic acid has caused severe outcomes. Strict SOP adherence is necessary to prevent mix-ups.

Emerging Safety Signals

Based on pharmacovigilance evaluations, AEMPS highlighted safety signals requiring attention:

• Captopril: Insulin autoimmunity and late-onset angioedema
• Cefditoreno: Severe skin reactions and neonatal screening interference
• Dostarlimab and Selpercatinib: Stevens-Johnson syndrome and other severe cutaneous reactions
• Isotretinoin: Acute generalized exanthematous pustulosis (PEGA)
• Simvastatin with Palbociclib or Ribociclib: Increased risk of rhabdomyolysis

These signals guide clinicians and regulatory teams in updating risk management plans and implementing GVP-compliant pharmacovigilance activities.

Updated Risk Prevention Materials

The bulletin also details updated educational and regulatory materials:

• Eculizumab (Bekemv): Controlled distribution requirements removed
• Siponimod (Mayzent): New guidance on immune reconstitution inflammatory syndrome (IRIS)
• NotificaRAM Manual: Updated instructions for ADR reporting in Spain

These tools support structured pharmacovigilance systems, helping teams comply with SOPs, ADR reporting, and risk minimization obligations.

Importance for Regulatory Compliance

Healthcare professionals and pharmaceutical companies should integrate these updates into PSURs/PBRERs, signal detection processes, and broader risk management frameworks. Timely ADR reporting and adherence to GVP standards remain essential to maintain patient safety and regulatory compliance.

Further operational guidance and pharmacovigilance support are available at:
https://baupharma.com/pharmacovigilance-services

Summary

The December 2025 AEMPS Drug Safety Bulletin highlights critical safety signals and updated risk prevention materials. By monitoring such bulletins, pharmaceutical companies and regulatory teams can ensure compliant pharmacovigilance, effective risk management, and timely reporting of ADRs.

For more information: AEMPS Bulletin