EMA’s PRAC reviews Deanxit following reports of persistent neurological effects and investigates batch-linked hypersensitivity reactions involving immunoglobulin medicines.
Written By: Anshu Gupta, PharmD
Reviewed By: Pharmacally Editorial Team
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has initiated a safety review of Deanxit following reports of serious neurological and psychiatric side effects. Separately, the committee is investigating increased reporting of hypersensitivity reactions associated with specific batches of human normal immunoglobulin medicines, including products that have undergone precautionary batch withdrawals in certain European Union (EU) Member States.
PRAC Starts Safety Review of Deanxit
The EMA, through its PRAC, has started a review of Deanxit (flupentixol/melitracen), a fixed-dose combination medicine used to treat depression and anxiety. The review follows reports of serious neurological and psychiatric side effects in patients receiving the treatment.
The reported cases involve movement disorders, including tremors, muscle stiffness, restlessness and involuntary movements, alongside problems affecting memory and thinking. In some patients, these symptoms persisted after treatment was discontinued, raising concerns about their duration and potential long-term consequences.
Although neurological and psychiatric side effects are already listed in the product information, the Belgian medicines agency triggered the review over concerns about their severity, duration, prolonged disability and the possibility that some effects may be irreversible. The agency also questioned the benefits of combining flupentixol and melitracen in a single formulation.
The PRAC will assess all available evidence to evaluate Deanxit’s overall benefit-risk balance. Depending on its findings, the review could result in the marketing authorisations being maintained, varied, suspended or revoked.
PRAC Investigates Hypersensitivity Signals Linked to Human Normal Immunoglobulins
In a separate safety assessment, the PRAC has started reviewing increased reporting of hypersensitivity reactions associated with specific batches of human normal immunoglobulin medicines.
These medicines are used to prevent infections in people who do not have sufficient antibodies, including patients with certain immune disorders and blood cancers. They are also used to treat conditions in which the immune system attacks the body’s own tissues.
Hypersensitivity reactions are recognised adverse effects of immunoglobulin treatment, and existing product information warns that serious reactions can occur even in patients who have previously tolerated therapy. However, recent reports indicate that these reactions may be occurring more frequently than expected with specific batches of certain products.
Reported reactions range from rash and itching to serious, potentially life-threatening events, including anaphylaxis and angioedema. Clusters of these cases have prompted precautionary withdrawals of specific batches of Flebogamma DIF, Yimmugo and Gamunex in certain EU Member States.
Investigations have not yet established the cause of these clusters. It also remains unclear whether other human normal immunoglobulin medicines could be affected.
The PRAC’s assessment will cover all human normal immunoglobulin medicines, irrespective of their administration route, including intravenous, subcutaneous and intramuscular formulations. The committee will request relevant data from marketing authorisation holders and assess the available evidence to investigate possible causes and determine whether additional risk-reduction measures are necessary.
Recommendations for Healthcare Professionals
The EMA has reminded healthcare professionals to follow existing product information warnings and precautions for human normal immunoglobulin medicines, including recommendations for monitoring patients during treatment.
Patients should seek medical attention without delay if they experience symptoms suggestive of hypersensitivity, such as rash, dizziness, palpitations, wheezing or difficulty breathing. These precautions remain important even in patients who have previously received immunoglobulin treatment without experiencing an adverse reaction.
The EMA will communicate further information following the outcome of the PRAC assessments.
Clinical Interpretation
The Deanxit review raises questions about the long-term safety and overall benefit-risk balance of a fixed-dose antidepressant and antipsychotic combination. The persistence of movement disorders and cognitive symptoms after treatment discontinuation makes the duration and potential reversibility of these effects important considerations. The review will also examine whether the therapeutic benefits justify the risks associated with combining the two active substances. However, reported cases alone do not establish causality.
The immunoglobulin investigation highlights a different pharmacovigilance concern: a batch-associated increase in hypersensitivity reporting involving products used across several clinical indications. The precautionary withdrawals and reports of severe allergic reactions reinforce the importance of existing monitoring measures. By extending its assessment across all human normal immunoglobulin medicines and administration routes, the PRAC aims to determine whether the signal is limited to particular batches or has broader implications for product safety. The underlying cause remains undetermined.
Reference
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26 – 29 October 2026, EMA, 30 October 2026
About the Writer
Anshu Gupta (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, regulatory affairs, and medical writing. She has presented research at academic conferences and completed certifications in Good Clinical Practice (GCP), ICH-GCP, and drug safety. Passionate about clinical trials and evidence-based medicine, she is committed to translating scientific evidence into accurate, reliable, and accessible healthcare content.
