Europe’s medicines regulator has launched reviews into two separate safety concerns: a long-established antidepressant linked to serious neurological side effects, and a spate of unexpected allergic reactions to certain batches of a widely used immune treatment. The decisions came out of the latest meeting of the Pharmacovigilance Risk Assessment Committee (PRAC), the European Medicines Agency’s safety arm, held in Amsterdam from 26 to 29 October.
What PRAC Actually Does
PRAC is the committee responsible for keeping an eye on the safety of medicines once they are already on the market. Approval is never the end of the story. Rare side effects often only surface when a drug is taken by hundreds of thousands of patients, far more than any clinical trial can include. When a worrying pattern emerges, PRAC can order a formal “referral” which involves a structured scientific review that can end in new warnings, restrictions, or in the most serious cases, a product being pulled from sale.
A Closer Look at Deanxit
The first review concerns Deanxit, a combination medicine of flupentixol and melitracen used to treat depression and anxiety. It has been on the market in parts of Europe for decades. PRAC has acted after reports of serious neurological and psychiatric problems in people taking it.
The side effects flagged include movement disorders, including tremors, stiffness, restlessness and involuntary movements, as well as difficulties with memory and thinking. More concerning still, in some cases the symptoms did not go away even after patients stopped taking the drug. That possibility of lasting harm is almost certainly what prompted the committee to act now rather than simply update the warning label.
One of Deanxit’s two ingredients, flupentixol, belongs to a class of older antipsychotic drugs already known to carry a risk of movement disorders, so the signal is biologically plausible. PRAC will now weigh whether the medicine’s benefits still outweigh its risks, and for which patients.
Allergic Reactions to Immunoglobulin Batches
The second review is arguably far more urgent. It concerns human normal immunoglobulin — antibody preparations made from donated human blood plasma. These medicines are a lifeline for people whose bodies cannot make enough antibodies of their own, including patients with certain immune disorders and blood cancers, and they are also used to calm conditions in which the immune system attacks the body’s own tissues.
Allergic reactions to these products are a known risk, and the labelling already warns that serious reactions can happen even in people who have tolerated the treatment before. But PRAC has picked up something new: reactions appear to be happening more often than expected with specific batches of certain brands. The reported cases range from rashes and itching to anaphylaxis (a sudden, life-threatening allergic reaction), and angioedema, a rapid swelling under the skin that can affect the face and throat.
Clusters of these cases have already led to batches of three products, Flebogamma DIF, Yimmugo and Gamunex, being recalled in some EU member states as a precaution. Crucially, investigators have not yet worked out what is causing the problem, nor whether other immunoglobulin products might be affected. For that reason, PRAC has cast its net wide: the review will cover all human normal immunoglobulin medicines, however they are given, whether into a vein, under the skin or into a muscle.
What Patients and Doctors Should Do
The agency has not told anyone to stop treatment. Instead, it is reminding healthcare professionals to stick to the existing precautions, including monitoring patients while the medicine is being given. Patients, for their part, are advised to seek medical help straight away if they notice signs of a rash, dizziness, palpitations, wheezing or breathing difficulties, even if they have never reacted before. PRAC will request data from the manufacturers and report back once it has reached a conclusion.
Both reviews are reminders that drug safety is a continuous process rather than a one-off verdict. The quiet, methodical work of committees like PRAC is how the rare problems that slip through initial testing eventually get caught.
European Medicines Agency (2026). Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26–29 October 2026. 30 October 2026. https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-26-29-october-2026
EMA start of referral — flupentixol/melitracen-containing medicinal products: https://www.ema.europa.eu/en/medicines/human/referrals/flupentixol-melitracen-containing-medicinal-products