Summary
The EMA’s PRAC has started reviewing reports of serious neurological and psychiatric effects linked to Deanxit, and increased allergic reactions associated with specific batches of human normal immunoglobulins. The reviews are investigations; the committee has not announced conclusions.
The European Medicines Agency (EMA) says its Pharmacovigilance Risk Assessment Committee (PRAC) has started two medicine-safety reviews: one concerning reports of serious neurological and psychiatric effects in people taking Deanxit, and another concerning increased allergic reactions reported with specific batches of human normal immunoglobulin medicines. The committee discussed the issues at its 26–29 October 2026 meeting.
These reviews are part of medicines monitoring: a safety signal is information suggesting a possible new association, or a new aspect of a known association, that warrants investigation. Starting a review is not the same as reaching a conclusion about a medicine’s risks.
Review of Deanxit reports
Deanxit is a fixed-dose combination of flupentixol and melitracen used to treat depression and anxiety. The reports prompting the review include movement disorders such as tremors, stiffness, restlessness and involuntary movements, as well as problems with memory and thinking. EMA says that in some reported cases, symptoms continued after treatment was stopped.
PRAC has begun a referral concerning flupentixol/melitracen-containing medicines. The review will assess the reported effects; the meeting highlights do not give a final assessment or announce a change to the medicines’ regulatory status.
Immunoglobulin reactions and batch withdrawals
Human normal immunoglobulins are antibody preparations used to help prevent infections in people who do not have enough antibodies, including some people with immune disorders or blood cancers. They are also used for conditions in which the immune system attacks the body’s own tissues. These medicines can be given intravenously, subcutaneously or intramuscularly.
Hypersensitivity reactions are already a known side effect, and product information warns that serious reactions can occur even in people who have tolerated treatment before. The new review concerns reports that such reactions may be occurring more frequently than expected with specific batches of some products. Reported reactions range from rash and itching to anaphylaxis, a sudden severe allergic reaction, and angioedema, rapid swelling that can affect the face or throat.
EMA says clusters of reports led to precautionary recalls in recent months of specific batches of Flebogamma DIF, Yimmugo and Gamunex in certain EU Member States. Those batches have been withdrawn from the market. PRAC’s review covers all human normal immunoglobulin medicines, not only the products named in connection with those recalls. It will request relevant data from the companies and assess it alongside available evidence to investigate possible causes and whether further risk-reduction measures are needed.
Advice while the reviews continue
EMA reminds healthcare professionals to follow existing product-information warnings and precautions, including monitoring patients during treatment. It advises patients to seek medical attention without delay if they experience signs such as rash, dizziness, palpitations, wheezing or difficulty breathing, even if they have previously received treatment without such a reaction.
The immediate regulatory significance is that PRAC is examining both reported adverse effects and, for immunoglobulins, a possible batch-related pattern. The committee has not yet established the cause of the immunoglobulin reaction clusters or whether other immunoglobulin medicines could be affected; EMA says it will communicate the outcome of the review.