EMA recommends withdrawal of levamisole medicines from the EU market after PRAC review links the drug to rare but serious leukoencephalopathy risk, citing unpredictable onset and safer alternatives
Written By: Pharmacally Medical News Desk
The European Medicines Agency (EMA) has recommended the withdrawal of medicines containing levamisole from the European Union following a safety review that identified a rare but serious neurological risk. EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the benefits of levamisole no longer outweigh its risks for treating parasitic worm infections in adults and children.
PRAC confirmed that levamisole can cause leukoencephalopathy, a potentially life-threatening condition involving damage to the brain’s white matter. Evidence reviewed by the committee showed that the reaction may occur even after a single dose, with symptoms appearing weeks or months after treatment. The onset was considered unpredictable, and no effective risk-minimisation measures or vulnerable patient groups were identified.
Several clinical reports have documented a direct link between levamisole exposure and severe white-matter brain injury consistent with leukoencephalopathy. A recent 2025 case report described a 49-year-old woman who developed fatal multifocal inflammatory leukoencephalopathy after exposure to levamisole-adulterated cocaine.
Another 2025 case series detailed progressive neurological decline in patients with levamisole-induced leukoencephalopathy, with multifocal white-matter lesions on imaging and poor clinical outcomes despite corticosteroid therapy, supporting a causal relationship between levamisole and inflammatory demyelination of the central nervous system.
Earlier literature also reports cases of levamisole-related demyelinating leukoencephalopathy occurring even with isolated levamisole exposure, reinforcing that the drug itself can trigger serious and sometimes irreversible neurological injury.
Given that levamisole is used for generally mild parasitic worm infections and that safer alternative anthelminthic medicines are available in the EU, regulators determined that continued use is not justified.
The recommendation was supported by spontaneous safety reports, published scientific literature, and input from independent experts in infectious diseases and neurology, along with consultation from the World Health Organization.
Levamisole is an oral anthelminthic typically administered as a single dose. It works by stimulating nicotinic acetylcholine receptors in parasites, leading to paralysis and expulsion of the worms. In the EU, levamisole-containing products are authorised in Hungary, Lithuania, Latvia, and Romania under the trade names Decaris and Levamisol Arena.
EMA advised patients previously treated with levamisole to seek medical attention if they develop neurological symptoms such as muscle weakness, speech difficulties, confusion, or problems with movement coordination. These effects may occur even after a single dose and may appear weeks or months after treatment.
EMA also advised clinicians that levamisole-associated leukoencephalopathy may present with varied neurological symptoms, including cognitive dysfunction, language impairment, ataxia, and paresis. Given the identified safety risk, healthcare professionals should consider alternative anthelminthic therapies where appropriate.
The review was initiated at the request of Romania’s medicines agency under Article 31 of Directive 2001/83/EC. PRAC’s recommendation will now be assessed by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).
CMDh represents EU Member States along with Iceland, Liechtenstein, and Norway, and is responsible for maintaining harmonised safety standards for medicines authorised through national procedures across the region. The CMDh will adopt a final position based on PRAC’s assessment.
Reference
EMA recommends withdrawal of marketing authorisations for levamisole medicines, 13 February 2026, https://www.ema.europa.eu/en/news/ema-recommends-withdrawal-marketing-authorisations-levamisole-medicines
PRAC recommends withdrawal of marketing authorisations for levamisole medicines, 13 February 2026, https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-9-12-february-2026
