The EMA’s Medicines Safety Committee — the PRAC — has recommended the withdrawal from the European Union of all medicines containing levamisole, which has been used for decades in the treatment of parasitic worm infections such asAscaris lumbricoides and thehookworm.
The recommendation was formalized on 13 February 2026 at the end of a European-wide review initiated at the request of the Romanian Medicines Agency (NAMMDR). The medicines involved, marketed under the names Decaris and Levamisol Arena, were authorized in Hungary, Lithuania, Latvia and Romania.
The security problem
The review confirmed the association between the use of levamisole and leukoencephalopathy, a condition that involves damage to the brain’s white matter — the tissue made up of myelin-coated nerve fibers necessary for the efficient transmission of signals between different brain areas. Depending on the location of the lesions, symptoms may include muscle weakness, speech disorders, cognitive difficulties, ataxia, and paresis. In more severe cases, if left undiagnosed and untreated, the condition can be fatal.
The benefits of levamisole-based medicines no longer outweigh the risks for the treatment of parasitic worm infections in adults and children – writes the EMA.
Among the elements that emerged from the analysis, one concerns the temporal variability of onset: symptoms can appear after a single dose and manifest themselves up to several months after treatment, making the diagnostic correlation complex. The review identified neither subgroups of patients at differentiated risk, nor measures capable of effectively reducing the risk.
Regulatory evaluation
To make its recommendation, the PRAC reviewed spontaneous reports of leukoencephalopathy and central nervous system demyelination linked to the use of levamisole — both in the authorized indication and in contexts of off-label or incidental use — as well as the available scientific literature. A group of independent experts in neurology and infectious diseases and the World Health Organization were also consulted.
Given that levamisole is indicated for generally mild parasitic worm infections and there are already therapeutic alternatives authorized for the same indications in the EU, the Committee considered that the benefit-risk profile of the drug no longer justified its continued existence on the market.
Next steps and practical indications
The PRAC recommendation will be forwarded to the CMDh — the coordination group representing EU Member States — for the adoption of the final position. The EMA has also prepared a direct communication to healthcare professionals (DHPC) with the clinical information necessary to manage any previous or ongoing situations.
Patients treated with levamisole who develop neurological symptoms — muscle weakness, difficulty speaking, confusion, coordination problems — are advised to contact their doctor, regardless of how long it has been since taking it. The treating doctors will be able to indicate the appropriate diagnostic paths and, where necessary, provide guidance on the available therapeutic alternatives.
And in Italy?
The Italian Medicines Agency (AIFA) also reported the news of the EMA’s PRAC recommendation, underlining however that in Italy, levamisole-based medicines are neither authorized nor marketed. This means that, unlike some EU countries such as Hungary, Lithuania, Latvia and Romania, in Italy no drugs containing levamisole are sold and there are no products on the market that could expose patients to the neurological risks associated with this active ingredient.
Sources: EMA / AIFA
