Haarlem: The European Medicines Agency announced a review of immunoglobulin allergic reactions on 30 October 2026, after its Pharmacovigilance Risk Assessment Committee (PRAC) met from 26 to 29 October. The review covers human normal immunoglobulin medicines tied to specific batches that triggered hypersensitivity reports. Authorities in certain member states have already withdrawn batches of Flebogamma DIF, Yimmugo and Gamunex as a precaution.

EMA said it has seen increased reporting of hypersensitivity reactions linked to specific batches. The immunoglobulin allergic reactions range from rash and itching to anaphylaxis and angioedema. The agency described the recalls as precautionary, but its meeting highlights name no countries and give no batch numbers.

The cause remains unknown. EMA wrote in its published highlights: “It is also not yet clear whether other human normal immunoglobulin medicines could be affected.” For that reason, the review covers all human normal immunoglobulins, whether doctors give them intravenously, subcutaneously or intramuscularly.

The October meeting was a busy one for the committee. According to the agency’s meeting statistics, PRAC discussed four safety signals, 67 periodic safety update reports and one referral. Regulators use such routine reviews to spot patterns that individual doctors and patients cannot see on their own.

PRAC monitors the safety of medicines on the EU market and advises the agency on risk. In this case, the committee will ask the marketing companies for data and assess what they send. It will then decide whether further risk-reduction measures are necessary.

EMA has set no deadline for that decision. The agency said it will communicate further on the outcome of the immunoglobulin allergic reactions review once the committee has finished its assessment.

In the meantime, EMA told healthcare professionals to follow the existing warnings and precautions in the product information, including monitoring patients during treatment. Patients should seek medical attention without delay if they develop a rash, dizziness, palpitations, wheezing or difficulty breathing. That advice applies even to people who have tolerated treatment before.

Human normal immunoglobulin medicines come from donated human plasma and treat patients whose immune systems cannot protect them adequately, among other uses. Hospitals and specialist clinics rely on these products, so batch withdrawals matter most to patients who depend on regular infusions. Any wider immunoglobulin allergic reactions finding could therefore affect supply as well as safety.

The same PRAC meeting also started a referral review of Deanxit, a fixed-dose combination of flupentixol and melitracen used for depression and anxiety. Reports describe serious neurological and psychiatric side effects, including tremors, stiffness, restlessness, involuntary movements and memory and thinking problems. EMA said symptoms persisted after treatment stopped in some cases.

For now, the immunoglobulin allergic reactions review is a data-gathering exercise, not a ruling. The full detail sits in the EMA PRAC meeting highlights, and patients with questions about their own treatment should speak to their doctor or pharmacist before changing anything.