Regulators Review Deanxit Safety and Immunoglobulin Risks
The Pharmacovigilance Risk Assessment Committee is investigating reports of neurological side effects and hypersensitivity reactions.
Updated on Oct. 30, 2026 in Allergies
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The Pharmacovigilance Risk Assessment Committee has launched safety reviews for the antidepressant Deanxit and specific batches of human normal immunoglobulin. These investigations follow reports of movement and memory disorders alongside serious hypersensitivity reactions like anaphylaxis.
Why it matters
The reviews aim to determine the root cause of these health risks, which have already prompted the recall of several immunoglobulin brands across the European Union. Identifying these triggers is critical for preventing further adverse patient reactions.
The Pharmacovigilance Risk Assessment Committee is evaluating reports of neurological conditions such as movement and memory impairment associated with Deanxit. Investigations also target hypersensitivity clusters linked to specific immunoglobulin batches.
The players
Pharmacovigilance Risk Assessment Committee
This is the European Medicines Agency committee responsible for assessing and monitoring the safety of human medicines.
European Medicines Agency
This is an agency of the European Union in charge of the evaluation and supervision of pharmaceutical products.
The details
The committee is requesting comprehensive data from manufacturers to compare against existing evidence for both Deanxit and all human normal immunoglobulin products. Recalls have already impacted specific batches of Flebogamma DIF, Yimmugo, and Gamunex in certain European Union Member States.
Timeline
The Pharmacovigilance Risk Assessment Committee met from October 26 to October 29, 2026.
Health Landscape
These reviews follow the formal process established by the European Union's pharmacovigilance safety monitoring protocols. The investigation mirrors historical efforts to isolate batch-specific risks within the wider pharmaceutical supply chain.
Patients currently prescribed Deanxit or receiving human normal immunoglobulin should monitor for signs of neurological changes or allergic reactions. Consult with a healthcare provider immediately if experiencing symptoms like angioedema or persistent movement disorders.
The takeaway
Ongoing medical reviews highlight the importance of reporting unexpected side effects to healthcare professionals to ensure product safety. Patients are encouraged to track any changes in their health while undergoing treatment and verify the safety status of their specific medication batches.
Further reading
For additional context on safety protocols, visit the Allergies section.
Source note: This article includes information reported by European Medicines Agency (EMA).
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