PharmacovigilanceOfficial

PRAC starts safety reviews of human immunoglobulins and Deanxit at October 2026 meeting

🇮🇹 AIFA · Fri 30 Oct 2026

AIFA says the EMA safety committee opened a review of hypersensitivity reports linked to immunoglobulin batches and a separate review of Deanxit over serious neurological and psychiatric effects.

The Pharmacovigilance Risk Assessment Committee (PRAC) started two safety evaluations at its 26-29 October 2026 meeting, according to an update the Italian Medicines Agency (AIFA) published on 30 October.

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

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

The AIFA page points to a related PDF with further information and reminds healthcare professionals and others of the importance of reporting suspected adverse reactions. The summary does not give a timetable for either review or say which batches are involved.

As general context, PRAC reviews of this kind assess whether the benefit-risk balance of a medicine or class remains favourable and can lead to recommendations such as label changes or other risk minimisation measures.

What it means for your team

  • Marketing authorisation holders for normal human immunoglobulin products should watch for PRAC scope, batch-related information and any requests for data.
  • Pharmacovigilance teams should check hypersensitivity case handling, including anaphylaxis and angioedema, for immunoglobulin products and be ready to review batch-level reporting.
  • Companies marketing flupentixol/melitracene products in other EU markets should track the review. Deanxit itself is not authorised in Italy.
  • The AIFA page does not set out the review timetable or outcomes, so teams should consult the linked PDF and PRAC publications for details.

Official source: AIFA ↗

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

More Pharmacovigilance All →