PharmacovigilanceOfficial

PRAC reviews allergic reaction signal across all normal human immunoglobulin medicines after batch withdrawals

🇸🇰 ŠÚKL · Fri 30 Oct 2026

EMA's safety committee will examine all normal human immunoglobulin products, whatever the route of administration, after more hypersensitivity reports linked to specific batches, according to ŠÚKL.

The Slovak medicines authority ŠÚKL has published conclusions from the 26–29 October 2026 meeting of the Pharmacovigilance Risk Assessment Committee (PRAC). It highlights a new signal: a higher number of hypersensitivity reports linked to particular batches of normal human immunoglobulin medicines.

Reports suggest that for some batches, hypersensitivity reactions occur more often than expected. Cases ranged from mild skin reactions such as rash and itching to severe, potentially life-threatening events, including anaphylaxis and angioedema. The reports led to batch withdrawals in recent months. These involved Flebogamma DIF, Yimmugo and Gamunex in some EU member states, and the batches were pulled as a precaution. ŠÚKL states that the batches concerned were not placed on the Slovak market.

Hypersensitivity is a known adverse effect of these products, and the product information already says reactions can occur even in patients who tolerated earlier treatment. However, the cause of the increase in reports has not yet been identified. It is also unknown whether other immunoglobulin products could be affected.

PRAC will therefore review all normal human immunoglobulin medicines, including intravenous, subcutaneous and intramuscular products. It will ask marketing authorisation holders for all relevant data and assess them alongside existing data. The aim is to clarify possible causes and decide whether further risk minimisation measures are needed. EMA will report once the review ends.

ŠÚKL says healthcare professionals should keep following the product information, including its patient monitoring recommendations. Patients should seek medical help at once if they develop symptoms such as rash, dizziness, palpitations, wheezing or difficulty breathing, even if they had no earlier reactions. The authority lists 13 brands authorised in Slovakia: CUTAQUIG, Cuvitru, Deqsiga, Flebogamma DIF, Gammanorm, Gamunex, Hizentra, HyQvia, KIOVIG, Octagam, Panzyga, Privigen and Xembify.

What it means for your team

  • Marketing authorisation holders of any normal human immunoglobulin product should prepare for PRAC data requests covering all routes of administration.
  • Quality and PV teams should check batch-level complaint and adverse event data for hypersensitivity trends, including anaphylaxis and angioedema.
  • Regulatory teams should watch EMA's PRAC highlights and the outcome of the review for possible risk minimisation or labelling changes.
  • Supply and market-access teams should note the recent precautionary batch withdrawals, and that no cause has yet been identified.

Official source: ŠÚKL ↗

Article written by VigiEye from the official source (ŠÚKL). AI-assisted; check the source before acting.

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