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The National Agency for Food and Drug Administration and Control received a notification that on 6 April 2026, the Italian Medicines Agency (AIFA) endorsed a safety recommendation to withdraw medicines containing levamisole from the EU market.

This recommendation was issued by the European Medicines Agency (EMA) safety committee known as the Pharmacovigilance Risk Assessment Committee (PRAC) following an EU-wide review which concluded that the benefits of Levamisole no longer outweigh its risks for the treatment of parasitic worm infections in adults and children.

Levamisole is an anthelmintic agent that acts by stimulating nicotinic acetylcholine receptors in parasitic worms, causing paralysis and subsequent expulsion of the parasites.

The review identified and confirmed leukoencephalopathy as a rare but serious side effect of levamisole. Leukoencephalopathy damages the white matter of the brain, which is made of nerve fibres covered by myelin (a protective layer that allows efficient communication between different parts of the brain). This condition can be debilitating and life-threatening, particularly if left untreated, and its diagnosis is complex.