PharmacovigilanceOfficial

PRAC opens safety reviews of human immunoglobulin batches and Deanxit, AIFA reports

🇮🇹 AIFA · Fri 30 Oct 2026

AIFA says the EMA safety committee started an assessment of hypersensitivity reports linked to specific normal human immunoglobulin batches and a review of Deanxit at its October meeting.

The Italian Medicines Agency (AIFA) has published an update on the October 2026 meeting of the EMA's Pharmacovigilance Risk Assessment Committee (PRAC), held on 26-29 October. According to AIFA, the committee launched two new safety evaluations.

The first concerns a rise in reports of hypersensitivity reactions associated with specific batches of medicines containing normal human immunoglobulins. AIFA says the reported events vary in severity, from skin manifestations to serious allergic reactions such as anaphylaxis and angioedema. The PRAC will assess the available data to clarify possible causes and determine whether further risk minimisation measures are needed.

The second is a safety review of Deanxit (flupentixol/melitracene), indicated for depression and anxiety. It follows reports of serious neurological and psychiatric adverse effects. AIFA notes that Deanxit is not authorised in Italy.

The agency points readers to a PDF communication, listed under related documents, for more information. It also reminds healthcare professionals and patients of the importance of reporting suspected adverse reactions so that medicines safety can be monitored continuously. The AIFA text does not give timelines for either assessment or say which products or batches are involved.

What it means for your team

  • Marketing authorisation holders of normal human immunoglobulin products should check the full PRAC communication and review batch-level hypersensitivity reports in their safety databases.
  • The immunoglobulin assessment may lead to further risk minimisation measures, but none have been announced yet.
  • Companies holding or distributing flupentixol/melitracene products outside Italy should monitor the Deanxit review for neurological and psychiatric safety implications.
  • Keep adverse reaction reporting channels active, as AIFA stresses the value of spontaneous reports.

Official source: AIFA ↗

Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.

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