Marketing authorisation for Litalgin products cancelled for safety reasons in summer 2024 – these products should no longer be used

Finnish Medicines Agency Fimea would like to remind the public that the marketing authorisation holder has terminated the marketing authorisations for Litalgin products due to the risk of agranulocytosis in summer 2024, at which time the products were also withdrawn from pharmacies.

The active substances in Litalgin products (tablet and injection solution) were metamizole and pitofenone. Agranulocytosis is a known, rare adverse effect of metamizole. Agranulocytosis refers to an acute condition involving a severe and dangerous lowered white blood cell count. White blood cells provide immune defence, and a lowered count can lead to serious, including fatal, infections.

Fimea has continued to receive individual reports of suspected adverse effects to the blood cells caused by Litalgin use, some of which have caused serious permanent consequences. Fimea emphasises that Litalgin products should no longer be used, and unused medicines should be returned to a pharmacy, hospital pharmacy or pharmaceutical wholesaler.

More information:

Fimea online news article 14 June 2024 (in Finnish): Litalgin-valmisteiden aiheuttamat valkosoluhaitat suomalaisilla potilailla – myyntiluvan haltija on päättänyt peruuttaa myyntiluvat vakavien valkosoluhaittojen vuoksi