The European Medicines Agency has initiated an immediate withdrawal of all levamisole-containing medications across EU member states following the identification of serious neurological adverse effects. The EMA’s Pharmacovigilance Risk Assessment Committee conducted a rigorous safety evaluation and recommended complete market removal, which was endorsed by the Italian Medicines Agency on April 6, 2026.
Levamisole, traditionally used as an antiparasitic agent, works through immune system modulation—a mechanism that appears linked to its neurological complications. Healthcare providers across Europe have been urged to review patient treatment plans immediately and identify individuals currently using levamisole products.
Regulatory authorities worldwide are monitoring this action closely. Nigeria’s National Agency for Food and Drug Administration and Control issued a public alert to notify domestic healthcare stakeholders of the safety concerns, demonstrating coordinated international pharmaceutical surveillance.
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