European Medicines Agency begins safety reviews for Deanxit and immunoglobulin medicines
On 30 October 2026, the European Medicines Agency announced that its Pharmacovigilance Risk Assessment Committee started two safety reviews following its meeting from 26 to 29 October 2026. The committee is examining Deanxit, a medicine containing flupentixol and melitracen used for depression and anxiety, after patients reported movement disorders, memory problems, and thinking issues that sometimes persisted after stopping treatment. In addition, the committee is reviewing human normal immunoglobulin medicines due to a higher number of reported allergic reactions than expected. These severe hypersensitivity cases led to recent recalls of specific batches of Flebogamma DIF, Yimmugo, and Gamunex in some European Union member states. Patients taking these treatments need to remain aware of potential side effects, while healthcare professionals are advised to follow existing product warnings and monitor patients during treatment. The committee will evaluate data from marketing authorization holders to decide if new safety steps are necessary across the European Union.
What was announced
The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency launched two safety reviews following its meeting held between 26 and 29 October 2026.
The first review focuses on Deanxit, a fixed-dose combination drug containing flupentixol and melitracen authorized for depression and anxiety. The decision follows reports of serious neurological and psychiatric side effects. Patients experienced tremors, stiffness, restlessness, involuntary movements, and memory problems. In several instances, these side effects continued after patients stopped taking the medicine.
The second review examines human normal immunoglobulin medicines. These products are given to patients with low antibody levels, immune disorders, or blood cancers. The committee noted an unexpected surge in reported allergic reactions linked to specific batches. Reactions ranged from skin rashes to severe conditions such as anaphylaxis and angioedema. Certain batches of Flebogamma DIF, Yimmugo, and Gamunex were already withdrawn from the market in selected European Union member states.
What it means
The review for Deanxit will determine whether additional safety measures or changes to product information are required across European Union countries. Patients noticing movement issues or memory difficulties should consult their medical provider.
For immunoglobulin therapies, the investigation covers all forms of administration, including intravenous, subcutaneous, and intramuscular injections. The committee plans to collect and evaluate data from pharmaceutical companies to identify the cause of the allergic reactions. The agency advises patients to seek immediate medical care if they experience symptoms like dizziness, sudden rash, wheezing, or difficulty breathing during or after treatment.
What the announcement does not tell us
The announcement does not state how long either safety review will take or when final decisions will be issued. It does not clarify whether other immunoglobulin brands beyond Flebogamma DIF, Yimmugo, and Gamunex might be affected.
Additionally, the agency does not state the exact cause of the increased allergic reactions. The document also leaves out the total number of patients affected by side effects from Deanxit or the recalled immunoglobulin batches.
How this was written
This analysis was written with AI from the official announcement below, using only facts that announcement states. The quoted wording is European Medicines Agency News’s own. Always check the original before acting on anything here.
PRAC starts review of depression and anxiety medicine Deanxit (flupentixol/melitracen)PRAC has started a review of Deanxit, a fixed-dose combination medicine for treating…, Agenda Agenda of the PRAC meeting 26 - 29 October 2026Draft Reference Number: EMA/PRAC/227255/2026…, PRAC statistics: November 2026 Monthly figures for PRAC outcomes based on the draft agenda. , PRAC statistics:…, Ongoing referrals Procedure: Flupentixol/melitracen-containing medicinal products - referralProcedure: Parenteral iron-containing medicinal products - referral, Glossary Safety signal assessments. A safety signal
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