Europe bans levamisole-containing medicines: which products and countries are affected

©Roberto Sorin via Unsplash

The European Medicines Agency (EMA) has taken a decisive step forward: its Pharmaco vigilance Risk Assessment Committee (PRAC) has recommended the withdrawal of all levamisole-based medicines from the European market. Levamisole is an active substance long used to combat infestations by intestinal parasitic worms such as roundworms (Ascaris lumbricoides) and hookworms.

The products covered by this recommendation, formalized on February 13, 2026, are marketed under the names 'Decaris' and 'Levamisol Arena'. They're authorized in four European Union countries: Hungary, Lithuania, Latvia and Romania. The review was initiated by the Romanian Medicines Agency (NAMMDR).

Why are they being withdrawn?

The central concern is the risk of leukoencephalopathy, a pathology that damages the brain's white matter and compromises the transmission of nerve signals. Symptoms can be severe - muscle weakness, language disorders, cognitive impairment, ataxia, paralysis - and, in the most severe cases, the disease can be fatal. A complicating factor in diagnosis is the variability of onset times: disorders may occur after a single dose, or manifest themselves several months after dosing. No category of patients at reduced risk has been identified, and no effective preventive measures have been established.

Given that parasitic infections treated with levamisole are generally benign, and that alternative thearapeutic alternatives are already authorized in the EU, the PRAC concluded that the risks outweigh the benefits.

What next?

The recommendation will now be forwarded to the CMDh (Coordination Group for Mutual and Decentralized Recognition Procedures), the body responsible for coordinating member states' regulatory authorities, for a final decision. Anyone who has been treated with levamisole and develops neurological symptoms is advised to consult their doctor, even if it has been a long time since they took the drug.

(©GreenMe.it 2026/Managing editor: Julie Morgan - The Press Junction/Picture: Roberto Sorin via Unsplash)