The European Medicines Agency (EMA) has taken a decisive step: its Medicines Safety Committee (PRAC) has recommended the withdrawal from the European market of all medicines based on levamisole, an active ingredient long used to combat infestations with intestinal parasitic worms such as Ascaris lumbricoides and hookworm.
What drugs are involved and where they are sold
The products affected by the recommendation — formalized on February 13, 2026 — are marketed under the names Decaris and Levamisol Arena and are authorized in four European Union countries: Hungary, Lithuania, Latvia and Romania. The review was initiated by the Romanian regulatory agency (NAMMDR).
Why are they withdrawn
The central problem is the risk of leukoencephalopathy, a pathology that damages the white matter of the brain, compromising the transmission of nerve signals. Symptoms can be serious — muscle weakness, speech difficulties, cognitive impairment, ataxia, paresis — and in more serious cases the condition can be fatal. An aspect that complicates the diagnosis is the temporal variability: the disorders can arise after just one dose or appear months after taking it. Neither categories of patients with reduced risk nor effective preventive measures have been identified.
As parasite infections treated with levamisole are generally mild and there are already authorized therapeutic alternatives in the EU, the PRAC concluded that the risks outweigh the benefits.
What happens now
The recommendation will now pass to the CMDh, the body that coordinates the regulatory authorities of the Member States, for the adoption of the final decision. Anyone who has received treatment with levamisole and experiences neurological symptoms is advised to contact their doctor, even if a long time has passed since taking it.
The situation in Italy
In Italy there is no direct risk: AIFA has confirmed that medicines containing levamisole have never been authorized nor marketed in our country.
Sources: EMA / AIFA
