PharmacovigilanceOfficial

PRAC starts Deanxit review and probes immunoglobulin batch allergy reports

🇪🇺 EMA · Fri 30 Oct 2026

EMA's safety committee opened a referral on flupentixol/melitracen and a review of hypersensitivity clusters across all human normal immunoglobulin medicines at its October meeting.

The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of Deanxit (flupentixol/melitracen), a fixed-dose combination used for depression and anxiety. The meeting ran from 26 to 29 October 2026, and EMA published its highlights on 30 October.

The review follows reports of serious neurological and psychiatric side effects. These include movement disorders such as tremors, stiffness, restlessness and involuntary movements, as well as memory and thinking problems. In some cases symptoms continued after treatment had stopped. EMA has issued a separate start-of-referral communication.

PRAC has also begun reviewing a safety signal on increased reporting of hypersensitivity reactions linked to specific batches of human normal immunoglobulin medicines. Reports range from rash and itching to anaphylaxis and angioedema. Clusters of cases have led to recalls of specific batches of Flebogamma DIF, Yimmugo and Gamunex in certain EU Member States, and those batches have been withdrawn as a precaution.

Investigations so far have not established the cause, and it is unclear whether other immunoglobulin products are affected. The review will therefore cover all human normal immunoglobulin medicines, whether given intravenously, subcutaneously or intramuscularly. PRAC will ask the companies concerned for all relevant data. EMA says it will communicate the outcome.

The highlights page also links to the flupentixol/melitracen and parenteral iron referrals under ongoing referrals. The meeting statistics list 67 single PSUR assessments, 42 risk management plans and 18 post-authorisation safety studies reviewed, and one referral started.

What it means for your team

  • Marketing authorisation holders for human normal immunoglobulins should expect PRAC data requests and prepare batch-level hypersensitivity case data, including complaint and recall information.
  • Holders of flupentixol/melitracen products should follow the referral procedure, as the outcome could change authorisations or product information.
  • Pharmacovigilance teams should check that existing hypersensitivity warnings and monitoring advice for immunoglobulins are being followed, as EMA has reminded healthcare professionals.
  • Quality and supply teams should note the batch-specific recalls and the open question over the cause, since the review could widen to other products.

Official source: EMA ↗

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

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