The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has launched comprehensive safety reviews regarding neurological side effects associated with the antidepressant ‘Deanxit’ and severe allergic reactions linked to human normal immunoglobulin products. This action follows the collection of adverse event reports across the European Union (EU) and aims to evaluate whether updates to patient safety guidelines and product marketing authorizations are necessary.
PRAC Initiates Re-evaluation Following Reports of Neurological and Psychiatric Side Effects for Deanxit
Following its regular meeting held from October 26 to 29, 2026, the EMA’s PRAC announced on October 30 that it has initiated an official referral procedure for ‘Deanxit,’ a fixed-dose combination of flupentixol and melitracen. Deanxit, prescribed for the treatment of depression and anxiety, has been brought under regulatory scrutiny due to reports of serious neurological and psychiatric side effects.
According to reports and preliminary data submitted to the committee, patients treated with Deanxit have reported significant motor disorders, including tremors, muscle stiffness, restlessness, and involuntary movements. Additionally, cognitive issues such as memory impairment and thought disorders have been observed. A primary safety concern is that these neurological symptoms have persisted in some patients even after treatment was discontinued.
Allergic Reactions and Batch Recalls for Human Normal Immunoglobulin
In addition to the Deanxit review, the PRAC has initiated a safety signal assessment for all human normal immunoglobulin products used to treat immunodeficiency and autoimmune diseases. This decision follows a surge in reports of hypersensitivity (allergic) reactions exceeding expected rates for specific manufacturing batches of these products, which are used to prevent infections in patients with immunodeficiency or hematological cancers.
The severity of reported hypersensitivity reactions ranges from simple skin rashes and itching to life-threatening reactions. These include anaphylaxis—an acute allergic shock—and angioedema, which involves swelling of the face and throat and risks airway obstruction. Consequently, specific batches of products such as Flebogamma DIF, Yimmugo, and Gamunex have been recalled in some EU member states over the past few months as a precautionary measure.
Expanded Investigation and Guidance for Healthcare Professionals and Patients
Despite preliminary investigations, the cause of the cluster of allergic reactions in specific batches has not yet been definitively identified. Therefore, the PRAC has expanded its review to encompass all human normal immunoglobulin products, regardless of the route of administration, including intravenous (IV), subcutaneous (SC), and intramuscular (IM) injections. The committee has requested that relevant pharmaceutical companies submit comprehensive data and will continue to evaluate whether further regulatory measures are required to mitigate risks.
The PRAC advises healthcare professionals to strictly adhere to the warnings and precautions currently specified in the product information and to enhance patient monitoring during the review period. Patients are urged to seek immediate medical attention if they experience suspected allergic symptoms, even if they have previously used the medication without incident.
- Hypersensitivity symptoms requiring immediate medical attention: Skin rash, dizziness, palpitations, wheezing, and shortness of breath.
- Major recalled medicinal products: Specific batches of Flebogamma DIF, Yimmugo, and Gamunex.
- PRAC October Meeting Statistics: 4 safety signals, 67 Periodic Safety Update Reports (PSURs), and 42 Risk Management Plans (RMP) reviewed.
Ongoing Referral Procedures and PRAC October Meeting Statistics
The PRAC’s list of ongoing referrals for October also includes the safety re-evaluation of parenteral iron-containing medicinal products, underscoring the committee’s rigorous ongoing safety oversight of major injectables and combination therapies within the Eurozone.
During the meeting held from October 26 to 29, 2026, the PRAC reviewed a total of 4 safety signals, including 1 new and 3 existing ones. Furthermore, the committee meticulously reviewed 67 Periodic Safety Update Reports (PSURs) covering both centralized and nationally authorized medicines, as well as 42 Risk Management Plans (RMPs)—including those for 10 new drugs—and 18 post-authorization safety study (PASS) protocols and results.
Future Procedures and Official Sources
The European Medicines Agency plans to publish its final safety recommendations and any necessary changes to marketing authorizations within the Eurozone once the scientific evaluation by the PRAC is concluded. This report is based on official announcements from the European Medicines Agency.
List of Official Sources:
- European Medicines Agency (EMA) – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26 – 29 October 2026 (Published: October 30, 2026): https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-26-29-october-2026