EMA Opens Safety Review of Immunoglobulin Batches

The European Medicines Agency's drug-safety committee opened two new reviews at its late-October meeting: one into a cluster of allergic reactions tied to specific batches of human normal immunoglobulin products already pulled from several EU markets, and a separate one into Deanxit, a combination antidepressant-anxiolytic sold under national licences in a handful of EU states. EMA published the highlights from the Pharmacovigilance Risk Assessment Committee's 26-29 October 2026 meeting on 30 October.

The immunoglobulin signal

Human normal immunoglobulin (IVIG/SCIG) products are pooled-plasma preparations used to treat primary immunodeficiency, certain autoimmune and neurological conditions, and other indications across dozens of brands. Hypersensitivity is a known, already-labelled risk for the class, and EMA's highlights note that current labelling already warns of serious reactions even in patients who have tolerated the product before. What changed at this meeting is scale and pattern: PRAC says clusters of hypersensitivity cases in recent months have been traced to specific batches, prompting precautionary recalls in certain EU Member States of named batches of Flebogamma DIF (Grifols), Yimmugo (Octapharma) and Gamunex (Grifols). The committee has now opened a formal review of the signal rather than treating the recalls as isolated, batch-level actions.

A separate complication for anyone tracking this space: the EU has also been managing a broader, unrelated human normal immunoglobulin supply shortage, which EMA's own shortage page attributes to manufacturing capacity and plasma-collection constraints, not a safety or quality defect, with an expected easing around mid-2026. RA/QA teams should keep the two issues distinct — a hospital pharmacy managing both a supply constraint and a hypersensitivity-driven batch withdrawal for the same product class needs separate escalation paths for each.

A parallel signal in the US

The EU signal is not occurring in isolation. AABB, the US blood-and-biotherapies association, reported on 7 October 2026 that FDA is separately investigating hypersensitivity reports tied to an IGIV lot in the United States. Regulatory News has not confirmed whether the US and EU signals involve the same manufacturer, lot, or root cause, and neither agency's public materials reviewed for this story draw that connection explicitly. The two concurrent reviews are reported here as a parallel development in the same product class, not as a confirmed single event.

The Deanxit review

PRAC's second new review concerns Deanxit, Lundbeck's fixed-dose combination of flupentixol (an antipsychotic) and melitracen (a tricyclic antidepressant), authorised nationally — not through the EU's centralised procedure — in a number of Member States including Belgium, Luxembourg, Spain, Greece, Cyprus, Malta and Austria, where it is used for anxiety and depressive symptoms. The product is not approved in Denmark, where Lundbeck is headquartered, nor in the UK, US or Australia. EMA's highlights attribute the review to reports of serious neurological and psychiatric side effects; the agency has not yet published the number or geography of those reports.

What RA/QA teams should watch

• Pharmacy and hospital supply chains carrying Flebogamma DIF, Yimmugo or Gamunex should confirm with their national competent authority whether their specific batch is among those already recalled, rather than assuming the PRAC review covers all lots of these products.
• Don't conflate the hypersensitivity signal with the ongoing EU immunoglobulin shortage — EMA treats them as separate issues with separate causes, and conflating them in an internal escalation or patient communication risks misdiagnosing the operational response needed.
• Sponsors with nationally authorised products in multiple EU states, as Deanxit is, should note that a PRAC safety review can proceed even without a centralised marketing authorisation triggering it — national-only licensure does not place a product outside EU pharmacovigilance oversight.

Frequently asked questions

What did PRAC start reviewing on human normal immunoglobulin products?

A safety signal on hypersensitivity reactions tied to specific batches, after clusters of cases led to precautionary recalls of named batches of Flebogamma DIF, Yimmugo and Gamunex in certain EU Member States.

Is this the same issue as the ongoing EU immunoglobulin shortage?

No. EMA treats the supply shortage, attributed to manufacturing and plasma-collection capacity, as a separate matter from the newly opened hypersensitivity signal review.

What is the Deanxit review about?

A PRAC review of Lundbeck's flupentixol/melitracen combination, nationally authorised in several EU states, following reports of serious neurological and psychiatric side effects.

What happens next?

EMA says it will communicate further once the immunoglobulin review concludes. Neither review had reached a recommendation as of this report.