PharmacovigilanceOfficial

PRAC opens Deanxit safety review and assesses immunoglobulin hypersensitivity signal linked to specific batches

🇸🇮 JAZMP · Tue 10 Nov 2026

EMA's safety committee began a referral on flupentixol/melitracen over serious neurological and psychiatric effects, and started a signal assessment of allergic reactions to human normal immunoglobulins.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency started two safety evaluations at its meeting of 26-29 October, according to highlights published by Slovenia's medicines agency, JAZMP.

The first is a review of Deanxit, a fixed-dose tablet combining 0.5 mg of flupentixol, an antipsychotic that blocks dopamine receptors, with 10 mg of melitracen, a tricyclic antidepressant. It is used for depression and anxiety. The review was triggered by reports of serious neurological and psychiatric adverse effects, including tremor, stiffness, restlessness, involuntary movements, and problems with memory and thinking. In some cases symptoms continued after treatment stopped.

These effects are already listed in the product information. The Belgian medicines agency requested the review because of concerns about their severity and duration, long-term disability among patients and the possibility that some effects do not resolve. It also questioned the benefit of combining the two active substances. Deanxit is authorised nationally in EU countries for indications including depression, anxiety, asthenia and psychological disorders presenting with physical symptoms. Medicines containing only flupentixol are not covered. JAZMP notes that Deanxit is not authorised or marketed in Slovenia. PRAC will assess the benefits and risks and decide whether marketing authorisations should be maintained, varied, suspended or revoked.

The second item is a signal assessment of an increased number of hypersensitivity reports linked to certain batches of human polyvalent immunoglobulins. These products are used to prevent infections in patients with antibody deficiencies, including some immune disorders and blood cancers, and to treat certain autoimmune conditions. Reported reactions ranged from rash and itching to potentially life-threatening anaphylaxis and angioedema. In recent months, some EU member states recalled specific batches of Flebogamma DIF, Yimmugo and Gamunex as a precaution.

The cause remains unknown, and it is unclear whether other immunoglobulin products are affected. The review will therefore cover all such medicines, whether given intravenously, subcutaneously or intramuscularly. PRAC will request key data from marketing authorisation holders and weigh it against the available evidence to explore possible causes and decide whether further risk-minimisation measures are needed. EMA will report the outcome of the signal assessment.

What it means for your team

  • Marketing authorisation holders of Deanxit should be ready for a referral that could end in maintained, varied, suspended or revoked authorisations.
  • Immunoglobulin MAHs should expect PRAC data requests covering all human polyvalent products, regardless of route of administration.
  • Pharmacovigilance teams should review hypersensitivity case reports and batch-level signal detection for immunoglobulins, and movement-disorder and persistent-symptom reports for flupentixol/melitracen.
  • Healthcare professionals are reminded to follow existing warnings and patient-monitoring advice, and patients should seek urgent care for signs of an allergic reaction.

Official source: JAZMP ↗

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

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